Positive Pregnancy Test Research Articles

Comparison of the assisted reproductive technology outcomes between conventional IVF and ICSI with donor oocytes in normozoospermic patients

There is no evidence for the superiority of conventional in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) using donor oocytes. This retrospective descriptive study aimed to compare the outcomes of conventional IVF (n = 506) and ICSI (n = 613) with donor oocytes in (n = 968) normozoospermic patients. Although the fertilization rate was statistically higher in the ICSI group (p < 0.001), conventional IVF provided better results than ICSI with respect to embryo quality (number of grade A embryos, p < 0.001). In addition, we observed more blastocysts in the conventional IVF group (p < 0.001) and more good quality embryos were obtained for cryopreservation compared to ICSI (p < 0.001). Regarding clinical results, there were no statistical significant differences in the positive pregnancy test, clinical pregnancy and clinical miscarriage rates between IVF and ICSI. However, the implantation rate was statistically higher when IVF was performed (50.4% vs. 43.0%, p = 0.031, OR (95% CI): 1.185 (1.050–2.530)). In conclusion, with the use of normozoospermic samples in our oocyte donation programme, IVF offers more embryo efficiency and increased implantation rates than ICSI.

Pre-conception 25-hydroxyvitamin D (25(OH)D) and fecundability.

Is pre-conception 25(OH)D associated with the per cycle probability of conception, i.e fecundability, in a prospective cohort study? There are suggestive associations of high 25(OH)D (at least 50ng/ml) with increased fecundability and low 25(OH)D (<20ng/ml) with reduced fecundability, but the estimates were imprecise. Vitamin D has been associated with reproductive function and fertility in animal studies, but few human studies exist. This community-based prospective cohort study included 522 women attempting to become pregnant between 2010 and 2016. The women completed online daily and monthly diaries until a positive home pregnancy test was observed or 12months had elapsed. The study included women from central North Carolina who were aged 30-44 with no history of infertility, with no more than 3 months of attempt time at recruitment. Women recorded vaginal bleeding so that the ongoing number of attempt cycles could be counted and used to quantify a woman's pregnancy attempt time. Blood collected at the study entry was analysed for 25(OH)D using liquid chromatography tandem mass spectrometry. Associations with fecundability were estimated with a log-binomial discrete time-to-event model. Among 522 women, 257 conceived during the study. The mean age was 33years and the mean 25(OH)D was 36ng/ml. There was an estimated 10% higher fecundability with each 10ng/ml increase in 25(OH)D (fecundability ratio (FR) 1.10, 95% CI: 0.96, 1.25). The suggestive dose-response association with the continuous measure of 25(OH)D was driven by women in the lowest and the highest categories of 25(OH)D. Compared to women with 25(OH)D of 30-40ng/ml, women below 20ng/ml had an estimated 45% reduction in fecundability (FR (CI): 0.55 (0.23, 1.32)), and women with at least 50ng/ml had an estimated 35% increase in fecundability (FR (CI): 1.35 (0.95, 1.91)). Across these three categories (25(OH)D of <20ng/ml, 30-40ng/ml and > 50ng/ml), the probability of taking longer than 6months to conceive was, respectively, 51% (17%, 74%), 28% (17%, 39%) and 15% (10%, 37%). While the distribution of 25(OH)D was wide, the number of observed cycles with high 25(OH)D (N = 107) or low 25(OH)D (N = 56) was small. Our findings are consistent with prior reports of reduced fertility in women with 25(OH)D concentrations below the clinically defined deficiency level (20ng/ml). Further studies are needed to evaluate the possible reproductive benefits of considerably higher 25(OH)D concentration (>50ng/ml). This research was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health (NIH) under award numbers R00HD079659 and R01HD067683 and supported in part by the Intramural Research Program of the National Institute of Environmental Health Sciences, under projects ES103086, ES049003 and ES044003. ClearBlue ovulation predictor kits were generously donated to AMZJ and AJW by Swiss Precision Diagnostics. Drs Wilcox and Jukic report non-financial support from Swiss Precision Diagnostics during the conduct of the study; Dr Jukic reports non-financial support from Theralogix, LLC, outside the submitted work. Otherwise there are no competing interests. N/A.

A Higher Estradiol Rise After Dual Trigger in Progestin-Primed Ovarian Stimulation Is Associated With a Lower Oocyte and Mature Oocyte Yield in Normal Responders.

Background: Prior studies have shown that patients with a >10% estradiol (E2) rise after trigger had more oocytes retrieved than plateauing or decreasing E2 responders. However, multiple follicles develop at different stages of maturation during controlled ovarian stimulation (COS) and may exhibit different responses to trigger. The association between the magnitude of E2 increase and oocyte retrieval outcomes is still unclear.Methods: This was a retrospective cohort study of 2,898 women undergoing their first COS cycles with normal response from January 2014 to December 2017 at a tertiary-care academic medical center. Patients were categorized into five groups according to the percentage increase in E2 levels before and after dual trigger: <10.0%, 10.0–19.9%, 20.0–29.9%, 30.0–39.9%, and ≥40.0%. Univariable and multivariable linear regression analysis were performed to explore the association between E2 increase and oocyte/mature oocyte yield, while logistic regression was used to assess its effect on low oocyte/mature oocyte yield (<10th percentile).Results: The post-trigger E2 increase was negatively associated with both oocyte yield (P-trend < 0.001, adjusted P-trend = 0.033) and mature oocyte yield (P-trend < 0.001, adjusted P-trend = 0.002). Compared with a <10.0% E2 increase after trigger, patients with a ≥40.0% rise had fewer mature oocyte yield [adjusted mean absolute difference [MD] = −5.2, 95% confidence interval [CI]: −8.2–−1.8] and higher risk of low mature oocyte yield (adjusted odds ratio [OR] = 1.64, 95% CI: 1.04–2.60), whereas no statistical significance was found in oocyte yield (adjusted MD = −2.7, 95% CI: −6.1–0.8) and low oocyte yield (adjusted OR = 1.48, 95% CI: 0.96–2.28). In addition, the rates of implantation, positive pregnancy test, clinical pregnancy, ongoing pregnancy, pregnancy loss, and live birth were comparable among the 1,942 frozen embryo transfer cycles with embryos originating from different groups of E2 increase (all P > 0.05).Conclusions: A higher E2 rise after dual trigger is independently associated with a lower oocyte and mature oocyte yield in normal responders. Further studies are needed to explore the efficacy of individualized time interval from trigger to oocyte retrieval based on the magnitude of E2 increase after trigger.

Recurrent Idiopathic Subglottic Stenosis in Multiple Pregnancies: A Case Report

Introduction: Idiopathic subglottic stenosis (ISS) is a type of central airway obstruction primarily affecting adult Caucasian females. Its rarity and similar clinical presentation to asthma contribute to its frequent misdiagnosis. Timely treatment of ISS is crucial for pregnant patients who are at risk for emergent surgeries necessitating ventilation and intubation.&#x0D; Case: A 29-year-old, previously healthy female reported new onset dyspnea on exertion and a dry, non-productive cough to her family physician. Clinical exam was unremarkable; however, pulmonary function testing revealed a moderate, fixed airway obstruction. Endoscopy visualized subglottic stenosis 1.7 cmdistal to her vocal cords and surgical intervention using CO2 laser dilatation was scheduled with Otolaryngology. However, the patient received a positive pregnancy test prior to her elective surgery dateand after consideration of risks and benefits to mother and fetus, the surgery was postponed to her second trimester. Unfortunately, the patient miscarried her fetus and was scheduled for an emergent dilatation and curettage (D&amp;C). She was successfully bag-mask ventilated during the D&amp;C and subsequently underwent surgery for ISS with full resolution of her symptoms. In subsequent follow-up, the patient reported a return of dyspnea coinciding with another positive pregnancy test. ISS recurrence was diagnosed; however, as symptoms were mild, a repeat surgery was postponed until the patient safely delivered her child.&#x0D; Discussion: This case illustrates the difficulties in the diagnosis and management of ISS in pregnant patients during their childbearing years as surgical intervention will impact both the mother and fetus.

Rationale and design of two prospective, multicenter, observational studies on reproductive outcome in women with recurrent failures after spontaneous or assisted conception: OTTILIA and FIRST registries

BackgroundSpontaneous pregnancy loss and implantation failure after assisted reproductive technologies (ART) are very common occurrences. Although 50–60% of all cases remains unexplained, various predisposing factors, including thrombophilias, have been identified. Thus, the potential benefit of a prophylaxis with low-molecular-weight heparins in improving outcomes has been often investigated over the years. However, the majority of studies are observational and results from randomized clinical trials (RCTs) are inconclusive, probably due to heterogeneity and limited sample size. To cover these unmet needs and to have further data mainly based on the real-life clinical management, we designed these multicenter registries.MethodsOTTILIA (Observational sTudy on antiThrombotic prevention in thrombophILIA and pregnancy loss) and FIRST (recurrent Failures in assIsted Reproductive Techniques) registries are two prospective, multicenter, observational studies to evaluate pregnancy or ART outcomes in consecutive women with previous reproductive failures after spontaneous or assisted conception, respectively. All enrolled women are observed from their first visit after positive pregnancy test (OTTILIA) or before commencing a new ART cycle (FIRST) until the end of pregnancy or ART procedure (negative pregnancy test/end of pregnancy, if successful cycle), respectively. Data are collected by means of questionnaires and recorded in a central database. Follow-up investigations are performed during hospital stay, routine clinical follow-up visits or telephone interviews. Primary outcome is live birth rate in the OTTILIA register and clinical pregnancy rate in the FIRST.DiscussionAlthough RCTs are the ‘gold standard’ for evaluating treatment outcomes, we believe that our registries represent a valid alternative in improving knowledge on mechanisms involved in reproductive failures and supporting future clinical decisions.Trial registrationNCT 02385461, retrospectively registered 5 March 2015 (OTTILIA); NCT 02685800, registered 10 February 2016 (FIRST).

A multicenter, randomized, phase III study comparing the efficacy and safety of follitropin alpha biosimilar and the original follitropin alpha

ObjectiveThe aim of the present study was to investigate the therapeutic equivalence between the follitropin alpha biosimilar and the reference medication in women undergoing assisted reproductive technologies (ART). Study designThis multicenter, randomized (1:1), embryologist-blinded, parallel-group, comparative phase III study involved 110 women aged 20–35 years old with tubal and/or male factors of infertility. All of the subjects underwent controlled ovarian hyperstimulation (COH) using a gonadotropin-releasing hormone antagonist (GnRH-ant) protocol. Over the 5-day fixed-dose regimen, the women received 150 IU/day of follitropin alpha biosimilar (n = 55) or original follitropin alpha (n = 55), followed by dose adaptation. The primary endpoint for assessing the therapeutic equivalence was the number of retrieved oocytes using a pre-determined clinical equivalence margin of ± 3.4 oocytes. ResultsSimilar numbers of oocytes were retrieved in both groups: 12.16 ± 7.28 in the follitropin alpha biosimilar group and 11.62 ± 6.29 in the original follitropin alpha group, with mean difference of 0.546 ± 1.297 oocytes (95% confidence interval [CI]: -2.026, 3.116), p = 0.002 (intention-to-treat [ITT] population). Additionally, no statistically significant differences were found for secondary endpoints: the onset of biochemical (34.7% and 36.7%, p = 0.883), clinical pregnancy (26.5% and 32.7%, p = 0.507), delivery (26.5% and 24.5%, p = 0.817) and take-home baby rate (28.6% and 26.5%, p = 0.816) for the follitropin biosimilar and original follitropin groups (per-protocol [PP] population). Ovarian hyperstimulation syndrome was observed in subjects with a positive pregnancy test in 0% and 3.64% of cases and after triggering ovulation in 7.27% and 3.64% for the follitropin biosimilar and original follitropin groups, respectively. ConclusionsThis study demonstrated similar therapeutic equivalence and safety profiles between the follitropin alpha biosimilar and the reference follitropin in women who underwent COH in GnRH-ant cycles. Trial registration number1. Name of the registry: ClinicalTrials.gov. Trial registration number: NCT03088137. Date of registration: 02.03.2017, retrospectively registered. Trial conducted between 08.02.2017 and 17.08.2018, the date of enrollment of the first participant – 08.02.2017. 2. Name of the registry: Russian Ministry of Health, grls.rosminzdrav.ru. Trial registration number: RCT 754. Date of registration: 26.10.2016, prospectively registered.

Effect of Adding L-Carnitine to Clomiphene Resistant PCOs Women on the Ovulation and the Pregnancy Rate

Background: polycystic ovary (PCO) syndrome is an endocrionologic disorder that affecting about 6-10% of women in their reproductive age. Conception rate with clomiphene citrate treated cycles is about 40% only and the number of ovulated oocyte decrease significantly with repeated cycles of ovulation. Objective: evaluation of the effectiveness of usage of clomiphene citrate with L-carnitine (LC) in induction of ovulation in clomiphene citrate resistant patients. Patients and Methods: Randomized controlled study included a total number of 50 women with clomiphene-resistant PCOs. They were divided into 2 groups, group (A) where patients received 100 to 150 mg clomiphene citrate from day three until day seven of the cycle and L-carnitine (LC) 3g daily till positive pregnancy test and group (B) received 100 to 150 mg clomiphene citrate with placebo. Results: There was statistically significant difference (p-value 17 mm and E2 on day of HCG injection. Conclusion: Adding L-carnitine to clomiphene from the follicular phase and extending through the luteal phase in patients with clomiphene-resistant PCOS, at the given dose and duration, may be of beneficial to the quality of ovulation and the clinical pregnancy rate.

Hysteroscopic treatment of Asherman's Syndrome

Objective: To assess achievement of hysteroscopic treatment for Asherman’s Syndrome(AS), also called ‘intrauterine adhesions(IUAs) or Intrauterine synechiae’. Method: Retrospectively,27 patients with AS were enrolled in our study at ankara liv hospital between 2017-2019 . These patients were evaluated with hysteroscopically then they had adhesiolysis at the same session. Monopolar knife was used for adesiolysis and the operation was gone on until adequate cavity enlargement was achieved. Intrauterine device (IUD) was placed in the new occurred cavity and combined hormonal therapy(high dose estrogen and progesteron) was given for two months. American Fertility Society classification was used for scoring of IUAs. After IUD was taken out, they were called and their menstrual pattern and fertility status were learned. If their symptoms were recurred they were hysteroscopically evaluated again. Results: 27 patients were hysteroscopically diagnosed as AS . 15of them had reproductive problems and other 12 patients had only menstrual abnormality. 13 patients had pregnancy related curettage, 4 patients had dilatation and curratage(D&C) for their menstrual problems. After hysteroscopic treatment, 6 of 12 patients with only menstrual abnormality had normal menstual pattern, 2 of them did not have normal period but a little bit better(from amenorrhoea to hypomenorrhoea). 8 of 15 infertile patients had positive pregnancy test(live born:6, spontaneous abortion:2). And also all these pregnant womens were seconder infertile patients. Conclusions: Hysteroscopy is the most useful technique for diagnosis and treatment for Asherman’s Syndrome. And also, hysteroscopic procedure has positive effect on pregnancy rate and menstrual regularity

Evaluation of Endometrial Scratching by Hysteroscope or Pipelle curette on The Outcome of Assisted Reproduction

IntroductionEndometrial scratching (or injury) is defined as intentional damage to the endometrium. The objective of this study was to investigate the effect of the method of endometrial scratching by hysteroscope or pipelle curette on the outcome of assisted reproduction. Scratching had done in the follicular phase of the preceding cycle to embryo transfer in infertile women aged 20-40 years.MethodsIn this study, 225 ICSI cycles were studied and divided into three groups: - hysteroscope group (75) scratching by scissor, pipelle group (75) scratching by pipelle curette, control group (75) no scratching had done. For each woman in hysteroscope and pipelle groups an appointment was scheduled on day7–14 of the cycle before the planned start of COS to perform endometrial scratching.ResultsThere were statistical significant differences between women in the pipelle group, hysteroscope group and control group as regard positive pregnancy test P value = 0.046, clinical pregnancy P value = 0.042, ongoing pregnancy P value = 0.039 and implantation rate P value = 0.044. With further analysis to each intervention group separately with control group, there were statistical significant differences between women in the pipelle group and control group. There was improvement in pregnancy rates in hysteroscope group than control group but with no statistical significant differences. ConclusionEndometrial scratching performed in the follicular phase of the preceding cycle to ovarian stimulation by pipelle curette or hysteroscope is associated with improved clinical and ongoing pregnancy rates in infertile women undergoing ICSI

Uterine Radial Artery Resistance Index Predicts Reproductive Outcome in Women with Recurrent Pregnancy Losses and Thrombophilia.

Uterine radial artery resistance index (URa-RI) by Doppler ultrasound may reflect the changes in the uteroplacental circulation and be associated with adverse events in early pregnancy. Recurrent pregnancy losses (RPL) are associated with thrombophilia, and anticoagulation treatment with low molecular weight heparin improves pregnancy outcome in women with RPL and thrombophilia. A retrospective cohort study was conducted in 139 pregnant women with 3 or more RPL and thrombophilia. The relationship between pregnancy outcome and dynamic changes of URa-RI was analyzed in 116 women who delivered a liveborn infant and 23 who miscarried the index pregnancy. Patients were on preconception low molecular weight heparin, low-dose aspirin (81mg per day), and prednisone treatment. URa-RI was measured during periovulation time, at the time of positive pregnancy test, and then repeated every two weeks until 32-week gestation or the time of miscarriage. The URa-RI at 8-week gestation was significantly higher in women who miscarried the index pregnancy than those who delivered alive born infant (0.51±0.08 vs. 0.42±0.03, P<0.001). Receiver operating characteristic curve analysis demonstrated that URa-RI of 8 wk gestation effectively distinguished women who miscarried from those who had a live birth with an area under the curve of 82.6% (95% CI 69.01-97.17). After adjusting for covariates including age, BMI, and number of miscarriages, multiple logistic regression models showed that each 0.1 unit increase of URa-RI of 8 wk gestation was associated with 18.70-point increase in the risk of miscarriage (OR19.70, 95%CI 4.26-91.1, P<0.001), and women with an URa-RI≥0.45 had an OR of 49.48 (95% CI 8.01-307.95; P<0.001) for miscarriage compared to those who had URa-RI<0.45. In women with RPL and inherited thrombophilia, increased URa-RI at 8-week gestation was associated with spontaneous abortion independent of other risk factors while they were on anticoagulation treatment.

Does Sperm DNA Fragmentation test in Cases of Male Factor Infertility Improve ICSI outcome?

Background: Sperm DNA fragmentation is an uprising factor af- fecting male fertility and some previous results have shown signifi- cant effect of SDF on ART techniques outcomes. Objective: To study effect of DNA fragmentation testing and treat- ment on ICSI outcome among infertile couples with male factor in- fertility. Patients and Method: After approval of ethics committee,prospec- tive control randomized study was conducted among a total of 106 infertile couples arranged for intracytoplasmic sperm injection (ICSI) due to male factor. Males were divided by simple random allocation into 2 groups. Group I included 53 males that were tested for DNA fragmentation test (Halo test). Group II included 53 males that were directly offered ICSI cycle.Infertile couples were evaluated as regard to fertilization rate, day 5 embryo transfer, positive pregnancy test, clinical pregnancy evaluated by visible sac with viable fetus on ultra- sonographic assessment and delivery of normal viable baby. Results: Men with initially negative DNA fragmentation test and those with positive DNA fragmentation test who responded well to treatment were found to have higher fertilization ratio of M2 ova, day 3 grade I embryo, blastocyte, positive pregnancy test and positive clin- ical pregnancy compared to non responders to treatment. There was no statistically significant difference between testicular and ejaculated sperm ICSI outcome among males with persistent sperm DNA frag- mentation test. Conclusion: Sperm DNA fragmentation is an important factor that significantly affects ICSI outcome. None of testicular or ejaculated sperm is superior regarding ICSI outcome among males with DNA fragmentation.

&lt;p&gt;No association between the presence of periodontal disease and poor IVF outcomes: a pilot study&lt;/p&gt;

Background: Periodontal disease can lead to bacteremia with release of cytokines, affecting implantation in women trying to conceive through in vitro fertilization (IVF). A potential association between maternal periodontal disease and poor IVF outcomes has been described.Objective: The aim of the study is to assess whether pre-existing periodontal disease has any effect on IVF parameters.Method: A pilot study composed of 34 women was conducted at a tertiary care center. Prior to IVF, dental examination, IVF parameters were collected.Results: Thirty-four women participated in the study. The outcomes of 28 women (82.3%) were analyzed. Out of the 28 patients, 17 patients had a positive pregnancy test (60.7%) with a total of 13 live births (46.4%) and 4 pregnancy losses (14.3%). Plaque and bleeding index scores were both lower in patients who achieved pregnancy after IVF yet did not reach statistical significance (p=0.309 and 0.422). Comparison of mean values for the different infertility parameters showed no significant differences among women with different IVF outcomes (p>0.05). Different degrees of inflammation of the gingiva did not have an effect on the different clinical parameters and the live birth rates.Conclusion: The evidence provided by the present study does not support the hypothesis. Addressing the status of oral health before any infertility treatment remains to be elucidated.

Compliance with daily, home-based collection of urinary biospecimens in a prospective, preconception cohort.

Exposures in the periconceptional environment may impact fertility and future health. Assessing time-varying exposures during the periconceptional window requires identifying approximate fertile windows around ovulation. In this prospective cohort study, we instructed women in daily cervical fluid observation and interpretation to identify incipient ovulation; they used this information to time daily urine collection for both partners. Timing and completeness of collection were compared to expert review. One hundred seventy couples planning pregnancy enrolled from community volunteers from 2011 to 2015; women were taught the Peak Day method to identify fertile windows. Both partners collected daily urine specimens from the first day of fertile-quality fluid (estimator of the beginning of fertile window). Men discontinued on the estimated day of ovulation/conception +2 days; women continued through the onset of next menses, or positive pregnancy test at estimated day of ovulation/conception +18 days. We compared dates from samples with participants' fertility charts to determine proportion correctly collected. Also, expert reviewers judged on which days urine should have been collected, determining investigator-identified sampling days. One hundred sixty-nine couples submitted 6,118 urine samples from 284 cycles. Reviewers and participants agreed in 87% of cycles for the date of the beginning of the fertile window ±3 days (65% exact-day agreement); agreement on ovulation date, ±3 days, was 93% (75% exact-day agreement). Five thousand three hundred twenty-nine female samples were expected based on investigator-identified sampling days, and 4,546 were collected, of which 82% were correctly collected on expected days. Fifty-nine percent of male samples were correctly collected relative to investigator-identified sampling days. Intensively-scheduled, biologically-triggered, at-home biospecimen collection can successfully be targeted to the periconceptional window and completed in a longitudinal cohort study.

Predictive Value of Single Serum Progesterone Level for Viability in Threatened Miscarriage.

Bleeding is commonly seen during early pregnancy, and predicting the outcome of pregnancy in such cases is a difficult task. The aim of our study was to evaluate the predictive value of single serum progesterone level for finding the viability in threatened miscarriage and to determine the cut-off value for a viable ongoing pregnancy. This was a prospective study in which patients attending the OPD with early pregnancy and bleeding were recruited. Inclusion criteria were period of amenorrhoea less than 12weeks, complaints of bleeding per vaginum with or without lower abdominal pain and positive urine pregnancy test or serum beta HCG. Multiple pregnancies, inevitable miscarriage, ectopic pregnancy, molar pregnancy and pregnancy achieved by artificial reproductive techniques were excluded from this study. A detailed clinical examination was done, and routine investigations along with serum progesterone were done. Patients were followed up by serial ultrasound for viability, and their outcome was recorded. A total of 150 patients with early pregnancy threatened miscarriage were enrolled for this study. Of the patients studied, 105 (70%) had a viable pregnancy and 45 (30%) had non-viable pregnancies. The mean serum progesterone was higher in the viable pregnancy, 17.97 ± 7.75ng/ml, compared to non-viable group, 6.21 ± 2.86ng/ml. The area under curve was calculated, and a cut-off value of 10.08ng/ml was obtained. 83.8% of viable pregnancies had serum progesterone more than or equal to 10.08ng/ml which was statistically significant. A single value of progesterone is useful in predicting the viability of the ongoing threatened pregnancy. Serum progesterone with a cut-off value of 10.8ng/ml was found to have a positive predictive value of 95.7% and negative predictive value of 70.7% with an accuracy of 86%.

The Influence of Poverty on Teen Pregnancy in Texas

The purpose of this proposed study is to better understand the relationship between poverty and teen pregnancy in the state of Texas. The aim is to show that adolescents are more likely to get pregnant if they reside in a low-socioeconomic environment when compared to adolescents who do not live in a low economic area. Using the family structural theory, we will view the important dynamics of how poverty and teen pregnancy affects the household and means of avoiding contraception. A descriptive, retrospective study design will be used to assess the relationship between poverty and the occurrence of teen pregnancy, in adolescent females, in Texas. A total of 168 participants will be utilized to conduct this research. Participants aged from 13 through 19 from all ethnicities who live in Houston, Texas without pre-existing diseases will be included in the study. Data will be conducted by a positive pregnancy test and the Harris County Admissions form to determine annual income, number of pregnancies, and members within the household. A chi-square analysis will be used to determine the correlation between poverty and teen pregnancy. This study will bring awareness to the healthcare community and facilitate a broader outlook on teen pregnancy.

SAT-LB044 HCG as a Predictor of Pregnancy Evolution in Patients Undergoing IVF

Human chorionic gonadotropin (hCG) levels in early pregnancy are predictive for pregnancy outcome after an embryo transfer (ET), however prognostic values are not consistent due to the different timing of the hCG sampling. The aim of this study is to establish a cutoff value of hCG as a predictor of a viable pregnancy, 10 days after performing a blastocyst ET. A cross-sectional, retrospective study was carried out in IVF cycles performed in our center between 2017 and 2018. Cycles included were fresh ET and frozen-thawed ET of blastocyst stage embryos that ended with a positive pregnancy test. Pregnancy was defined as a rise in hCG above 20 IU/L. All measurement of hCG levels were performed 10 days after the ET. A transvaginal ultrasound was performed on week 6 to confirm pregnancy. Pregnancies through preimplantation genetic test were excluded. A probable viable pregnancy was defined as a pregnancy greater than 12 weeks of gestational age, and a non-viable pregnancy as a positive hCG blood test with the consequent results: early miscarriage, biochemical pregnancy and ectopic pregnancy. Biochemical pregnancy was diagnosed if no sign of pregnancy was evident on ultrasound examination, miscarriage as pregnancy loss after ultrasonic visualization of a gestational sac. Ectopic pregnancies were diagnosed by transvaginal ultrasound. Results were not adjusted by multiple pregnancy. A level of statistical significance <5% was used. A total of 241 cases were included. Patients were classified according to their evolution in: Viable pregnancy: Pregnancy greater than 12 weeks of gestational age and pregnancy resulting in live birth. Non-viable pregnancy: Miscarriage, biochemical pregnancy and ectopic pregnancy. Out of the 241 cases, 161 patients presented viable pregnancies versus 80 patients with non-viable pregnancies; 43 miscarriages, 32 biochemical pregnancies, 5 ectopic pregnancies. An optimal hCG value was proposed as a predictor of pregnancy prognosis, comparing initial hCG values with the final outcome of the case. Cutoff values were proposed every 20 miU/mL from values of 80 mIU/mL up to 360 mIU/mL. For each value the Recall and the Precision were defined and graphed in a “PR” curve. The optimal cutoff value calculated, where the proportion of true positives is very high with respect to the amount of false positives, corresponds to 140 mIU/mL, statistically significant; p<0.0000. There was no statistical difference in hCG levels between fresh and frozen cycles. Considering that there is a statistically significant relationship between hCG values <140 miU/mL and non-viable pregnancies, an hCG value greater than or equal to 140 mIU/mL 10 days after performing a blastocyst stage ET can be used as a predictor of a pregnancy with a good prognosis during the first trimester, helping to better advice and monitor patients. Unless otherwise noted, all abstracts presented at ENDO are embargoed until the date and time of presentation. For oral presentations, the abstracts are embargoed until the session begins. s presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.

SAT-443 Osilodrostat Has No Clinically Relevant Effect on the Pharmacokinetic (PK) Profile of a Monophasic Oral Contraceptive in Healthy Females Receiving Cortisol Replacement Therapy

Background: Osilodrostat, a potent oral 11β-hydroxylase inhibitor, is in Phase 3 development for endogenous Cushing’s syndrome (CS). As CS occurs mostly in females of childbearing age, it is important to determine the effect of osilodrostat on oral contraceptives (OCs). We report the effect of multiple osilodrostat doses on the PK profile of a single OC dose in healthy females on cortisol replacement. Methods: This Phase 1, single-center, open-label, three-period, drug-drug interaction study enrolled healthy, non-smoking females aged 18-50 y with regular menstrual cycles. A single OC dose, containing ethinyl estradiol (EES) 30 μg and levonorgestrel (LVG) 150 μg, was given on day (D) 1 of treatment period 1 (TP1; D1-7). In TP2 (D8-19), osilodrostat 30 mg twice daily was given with hydrocortisone 20 mg daily; a second OC dose was given on D15. Hydrocortisone was tapered/discontinued during TP3 (D20-28). Primary variable: AUClast (area under curve from time 0 to last measurable concentration) and Cmax (peak plasma concentration) of EES and LVG, calculated from a 120h OC PK profile on D1 and D15. Secondary endpoints: osilodrostat PK; safety/tolerability of OC and osilodrostat co-administration. Results: 24 subjects were enrolled (mean ± SD age, 37 ± 7 years; Caucasian, 96%). EES and LVG AUClast were similar when OC was given with osilodrostat (n=19) vs alone (n=24) [geometric mean: EES, 541 vs 537 pg∙h/mL; LVG, 44900 vs 42300 pg∙h/mL]. Insignificant decreases in Cmax were seen for OC with osilodrostat vs alone (geometric mean: EES, 51.6 vs 59.8 pg/mL; LVG, 3360 vs 3800 pg/mL). Apparent total clearance, t½ (half-life) and tmax (time to Cmax) were similar with and without osilodrostat for EES and LVG, except for a small increase in t½ of LVG with osilodrostat (26.4 vs 22.9 h). For osilodrostat PK (n=19), geometric means for AUCτ (AUC to end of dosing period at steady state) and Cmax, and median tmax, were 1620 ng∙h/mL, 299 ng/mL, and 1.0 h, respectively. Most (92%) subjects received both OC doses; 83% completed osilodrostat treatment. At the end of TP3 (2 days after last hydrocortisone dose), 79% of subjects had ACTH-stimulated serum cortisol below the protocol-defined threshold, although all had normal unstimulated levels at study end; these results may be related to high osilodrostat doses, hydrocortisone supplementation, timing of first stimulation test after last hydrocortisone dose or another factor. Other common AEs: nausea (46%), headache and nasopharyngitis (both 38%). Four (17%) subjects discontinued due to: palpitations, n=1; throat tightness, n=1; asthenia and exhaustion, n=1; positive pregnancy test, n=1 (not confirmed by ultrasound). Conclusion: Concomitant treatment of osilodrostat (highest dose used in Phase 3 trials) with a single OC dose did not result in clinically relevant changes in OC PK parameters, suggesting that OC can be given with osilodrostat and provide adequate contraception.

Corifollitropin- compared to daily r-FSH in for patients undergoing intracytoplasmic sperm injection: Clinical trial study.

BackgroundThe current treatment regimen for ovarian stimulation in Intracytoplasmic sperm injection (ICSI) patients is daily injections of Gonadotropins. Recombinant DNA technologies have produced a new recombinant molecule that is a long-acting Follicle Stimulating Hormone (FSH), named corifollitropin alfa. A single injection of long-acting FSH can replace seven daily FSH injections during the first week of controlled ovarian stimulation (COS) and can make assisted reproduction more patients-friendly. There is limited data with different results in this area.ObjectiveTo compare the effectiveness of long-acting FSH vs. daily r-FSH in terms of pregnancy and safety outcomes in women undergoing ICSI cycles.Materials and MethodsIn this clinical trial study, 109 women who were the candidates for ICSI at azzahra hospital were divided in two groups. The first group received 150 units of daily Gonal-f from second or third day of menstruation. The second group received a 150IU corifollitropin alfa on the second or third day of mensuration, and the treatment continued from day eighth of stimulation with Gonal-f based on the ultrasound finding. Both the groups received GnRH antagonist from fifth day of stimulation. Two groups were compared in terms of number of dominant follicles, number of oocytes, stimulation duration, total number of embryos, number of transferred embryos, and success rate of pregnancy.ResultsNo significant difference was found between the two groups in terms of stimulation duration, number of follicles, number of oocytes, total number of embryos, and number of transferred embryos. Moreover, pregnancy outcomes including chemical pregnancy rate (positive pregnancy test), clinical pregnancy rate (detection of fetal heart), the rate of ovarian hyper-stimulation syndrome, multiple-pregnancy, ectopic pregnancy, and miscarriage didn't have a significant difference between the two groups.ConclusionAs corifollitropin alfa was as effective as r-FSH, it could be used as an alternative to ovulation stimulation method in patients undergoing ICSI.

Laparoscopic Reversal of Tubal Sterilization; A Retrospective Study Over 135 Cases.

Objectives: To evaluate the pregnancy and delivery rates of laparoscopic tubal reanastomosis.Study Design: From 2003 to 2013, 135 laparoscopic tubal reversals were performed according to the four stitch technique. The parameters studied, included positive pregnancy test, miscarriage, ectopic pregnancy, termination of pregnancy, term delivery, post-operative time to conception, post-operative hysterosalpingography, and spermogram.Results: From the 135 patients operated, 93 fulfilled the inclusion criteria. The age of patients varied from 27 to 47 years old. All ages combined, positive β-HCG blood sample rate was 75.3% (95% CI: 65.0–83.4%) and term delivery 52.7% (95%CI: 42.1–3.0%). The age-adjusted pregnancy and delivery rates were as follows: 27–35 y.o. (n = 23) 95.7% (95%CI: 76.0–99.8%) and 73.9% (95%CI: 51.3–88.9%),36–39 y.o. (n = 40) 77.5% (95%CI: 61.1–88.6%) and 47.5% (95%CI: 31.8–63.7%),40–42 y.o. (n = 19) 68.4% (95%CI: 43.5–86.4%) and 52.6% (95%CI: 29.5–74.8%),43–47 y.o. (n = 11) 36.4% (95%CI: 12.4–68.4%) and 27.3% (95%CI: 7.3–60.7%).Conclusions: In our series the pregnancy and delivery rates after laparoscopic reversal of tubal sterilization is estimated at 75.3 and 52.7%, respectively. For women with tubal sterilization and no other infertility factors, reanastomosis can restore anterior natural fertility related to age. Laparoscopic reversal should be proposed systematically to patients and performed by well-trained laparoscopists, avoiding potentially the inconvenient and adverse outcomes of an IVF treatment. Although, it may seem a more cost-effective technique compared to robotically assisted reversal, a prospective randomized trial could answer this question.

Reassessing the role of the human chorionic gonadotropin (hCG) discriminatory zone in the evaluation of patients with a pregnancy of unknown location

Objective This study aimed to determine the usefulness of the Human Chorionic Gonadotropin (hCG) Discriminatory Zone (DZ) (defined as the serum hCG value above which an intrauterine gestational sac is consistently seen on ultrasound in normal pregnancies1) as a diagnostic tool in the evaluation of patients presenting symptomatically (lower abdominal pain and/or vaginal bleeding) with a pregnancy of unknown location (PUL). A PUL is defined as a clinical scenario where a woman has a positive pregnancy test and no evidence of either intrauterine pregnancy or ectopic pregnancy on transvaginal ultrasound2. This objective will be achieved in this study by asking three questions: Firstly, how useful is the DZ in identifying an ectopic pregnancy? Secondly, how useful is the DZ in identifying a failed intrauterine pregnancy? And third, can a patient with an hCG level above DZ levels and a PUL following the initial scan can progress to a live, intra uterine pregnancy? Methods A retrospective chart review of ultrasound records at one, large urban hospital in Auckland, New Zealand identified 97 patients with lower abdominal pain and/or vaginal bleeding, who had serum hCG testing and transvaginal ultrasound performed within 12 hours of initial hospital presentation. The following information was recorded: hCG level, initial ultrasound findings, follow up outcomes, age, gravida and parity. Statistical analysis using Kruskal-Wallis and Wilcoxon were then performed. Results In total, 97 women met the criteria and were included in the study. Twenty-seven women had an hCG level of 1000 IU/L or higher, with true PUL on ultrasound. Of these, three went on to develop a normal intrauterine pregnancy, three were ectopic and 20 were miscarriages. The highest hCG value with a true PUL that progressed to a live intrauterine pregnancy was 2767 IU/L. The hCG discriminatory zone showed wide variability in hCG values and no statistically significant difference between median hCG values in the initial transvaginal ultrasound groups. The difference in median hCG values were found to be statistically significant between the final outcome groups of IUP, miscarriage and ectopic. However, the large overlap in values across the groups shows that hCG has low specificity. Conclusion This study recommends limited reliance on the hCG DZ and raises awareness of the high variability of hCG values. The hCG DZ was not shown to be useful in this study in the evaluation of women with a pregnancy of unknown location.