Chorionic Gonadotropin Research Articles

New tumor markers for testicular cancer - in the here and now and in the future

Germ cell tumors of the testis are the most common tumor entities in young men. Since the introduction of platinum-based chemotherapy in the 1970s, most patients can be cured despite the aggressiveness of germ cell tumors. Optimal serum tumor markers are required for diagnostics, therapy monitoring and aftercare, and these are subject to high requirements. The conventional testicular tumor markers human chorionic gonadotropin (hCG), alpha fetoprotein (AFP) and lactate dehydrogenase (LDH) only meet these requirements with insufficient sensitivity (30-70%). The markers investigated in recent decades, such as PLAP, CEA and NSE, have not become established. Currently, miRNA-371 is being researched in particular. Reliable findings are available for initial staging with significantly better specificities of miRNA-371 compared to conventional tumor markers. Further prospective studies are being conducted for other possible clinical applications, such as follow-up care, therapy monitoring or residual tumors, in order to investigate the revolutionary potential of miRNA-371 in these areas as well. Research is also currently being conducted on circulating tumor cells (CTCs) and cell-free DNA (cfNA) in various areas of application. With regard to germ cell tumors of the testis, however, these analyses are still in their infancy, but it is hoped that this will provide a further sufficient opportunity to use serum tumor markers.

Vaginal cytology during the estrous cycle and early pregnancy of ewes

Changes in vaginal epithelial cells and blood progesterone and estrogen concentrations were compared between estrous cycle and early pregnancy in multiparous Sanjabee ewes. Twenty non-pregnant ewes were synchronized with intravaginal insertion of a controlled internal drug release (CIDR) device which was in place for 7 days, intramuscular administration of a GnRH analog (Alarelin acetate; 12.5 µg) at the time of CIDR insertion (Day -7), a PGF2α analog (D-cloprostenol sodium; 125 µg) and 500 I.U. of human chorionic gonadotropin (hCG) at the time of CIDR removal (Day 0). At Day 0, all ewes were introduced to four fertile rams and observed for estrous signs. Ewes exhibiting estrous signs were divided into two groups: MATED (confirmed pregnant with transrectal ultrasound scanning at Day 35) and NOT-MATED (confirmed non-pregnant with transrectal ultrasound scanning at Day 35). Vaginal smears and blood samples were taken daily and every other day, respectively, from the beginning of estrus for 20 days for cytology and hormone assay. Based on the results, during days 0 and 1 of the estrous cycle, only the percentages of intermediate cells differed between the groups (P < 0.05). During days 2 to 4, there was no difference in the cell populations between the groups (P ≥ 0.05). During days 5 to 16, the percentages of all cell types except the parabasal cells differed between the groups (P < 0.05). During days 17 to 20, the percentages of all types of vaginal epithelial cells differed between the groups (P < 0.05). Progesterone concentrations increased gradually from days 0 to 14 of the estrous cycle in both groups, however, they decreased significantly afterward in the NOT-MATED group. Estrogen concentrations changes showed an opposite pattern to that of progesterone in the study groups. Collectively, vaginal cytology can be used as a useful tool in assessing hormonal and physiological characteristics of the female reproductive system and thus provides a more accurate understanding of the physiology of estrous cycle and early pregnancy in ewes, which can be used to improve reproductive management.

A case report on renal metastasis as an unusual presentation of choriocarcinoma

BackgroundChoriocarcinoma is an aggressively invasive neoplasm, characterized by its rapid proliferation and propensity for metastasis to distant organs via hematogenous dissemination. Lungs (80%), vagina (30%), pelvis (20%), liver (10%), and brain (10%) are the most frequently metastasized organs. Renal metastases are very rare. The clinical manifestations of choriocarcinoma varies depending on the site of disease, making diagnosis challenging. In this report, we provide a clinical case of choriocarcinoma with metastases to the renal and pulmonary systems, displaying symptoms akin to those observed in ectopic pregnancy.Case presentationA 27-year-old female, G2P1, with a previous history of full-term pregnancy in 2018, presented to the hospital with the onset of vaginal bleeding and accompanying abdominal aches. Investigations uncovered a left adnexal mass with a human chorionic gonadotropin (hCG) level of 77,4 mIU/mL and a left pulmonary nodule measuring 31 mm x 21 mm. Laparoscopy was performed due to the high suspicion of an ectopic pregnancy. However, no visible villi were identified during the surgery, and postoperative blood hCG levels continued to rise. A diagnostic curettage also failed to reveal any villi, maintaining the suspicion of a persistent ectopic pregnancy. Following two ineffective courses of methotrexate therapy, the patient was referred to our facility. Prior to her referral, an ultrasound had indicated a mass in the right kidney. However, upon arrival at our hospital, subsequent ultrasonography failed to detect any renal masses. Despite two months of outpatient monitoring, there was a sudden and significant increase in her serum hCG levels. An emergency laparoscopy was performed, revealing no pregnancy-related lesion. After surgery, the patient’s hCG levels dropped dramatically to less than one-tenth of the original amount. Multisite enhanced computed tomography(CT)revealed suspicious lesions in both the renal and pulmonary regions. Upon thorough multidisciplinary consultation, a diagnosis of choriocarcinoma was entertained. Consequently, the patient successfully underwent eight cycles of chemotherapy and has remained recurrence-free for the past year.ConclusionsThis case underscores the potential for choriocarcinoma in women of reproductive age who exhibit radiological signs of renal masses. Early and accurate diagnosis, followed by prompt intervention, is essential to prevent needless surgery procedures.

Boric acid supplementation promotes the development of in vitro-produced mouse embryos by related pluripotent and antioxidant genes.

Boric acid (BA) is an important mineral for plants, animals and humans that assists metabolic function and has both positive and negative effects on biological systems. The present study aimed to investigate the effects of different concentrations of BA added to the culture media, the quality and in vitro development potential of mouse embryos. Superovulated C57Bl6/6j female mice were sacrificed ∼18 hours after human chorionic gonadotropin (hCG) injection. Single-cell-stage embryos were collected from the oviduct, divided into experiment groups and cultured in embryo medium with supplemented BA+ in 5% CO2 at 37 °C until 96 hours at the blastocyst stage. The blastocyst development rates of 0, 1.62 × 10-1, 1.62 × 10-2, 1.62 × 10-3 and 1.62 × 10-4 µM BA were 51.52%, 73.47%, 77.36% and 81.13%, respectively. The in vitro development rates were significantly higher in the 1.62 × 10-3 (p < 0.05) and 1.62 × 10-4 µM BA groups than in the control group (p < 0.001). These results indicated that low BA doses influenced embryo development by positively affecting in vitro development rates, embryo cell numbers, biochemical parameters and development at the molecular level by pluripotent and antioxidant genes. Therefore, BA seems to play an important role on in vitro embryo development.

Does hCG-trigger in the mild stimulation protocol for endometrial preparation have any effect on pregnancy outcome in frozen-thawed embryo transfer?

BackgroundRecent literature has explored the role of human chorionic gonadotropin (hCG) triggering in frozen embryo transfer (FET) cycles with natural endometrial preparation. Despite this, the impact of hCG triggering on pregnancy outcomes following endometrial preparation with mild stimulation (mST) using Letrozole and Gonadotropins remains inadequately characterized. This study aimed to elucidate the effects of hCG-trigger on pregnancy outcomes in mST-FET cycles.MethodsIn the present retrospective cohort study, the pregnancy outcomes of 409 eligible patients who underwent FET cycles with endometrial preparation using a mild ovarian stimulation protocol by letrozole plus low dose gonadotropins at the Royan Institute between 2020 and 2022, were investigated. The study population were segregated into two distinct groups according to type of ovulation: the spontaneous ovulation group (n = 138) and the hCG-trigger group (n = 271). The pregnancy outcomes including implantation and clinical pregnancy rates (CPR) and live birth rates (LBR) were compared between two groups. The multivariable logistic regression was performed to detect the most significant variables related to the LBR in the mST-FET cycles.ResultsDemographic and baseline characteristics were comparable between groups. No significant difference was found in terms of implantation rate (0.65 ± 0.32 vs. 0.60 ± 0.30, P-value: 0.31), CPR (37% vs. 39.7%, P-value: 0.53), and LBR (35.5% vs. 37.3%, P-value: 0.74) in the spontaneous ovulation and hCG-trigger groups, respectively. The logistic regression analysis revealed that only the stage of the transferred embryo exhibited a significant relationship with LBR (blastocyst vs. cleavage: odds ratio (OR); 2.33, 95% confidence interval (CI):1.41–3.86, P-value = 0.001).ConclusionPregnancy outcomes in the mST-FET cycles, including implantation rate, CPR, and LBR are comparable in cycles with or without hCG triggering. Based on the findings from multivariate regression analysis, the sole significant predictive factor for the LBR was the transfer of blastocyst embryos. It is recommended that these results be examined and discussed in future prospective studies with a larger sample size, considering the lack of comparable research in this field.

A case report of late detection of primary mediastinum herm cell tumor

Germ cell tumors are rare malignant neoplasms. Extragondal localization accounts for about 10% of all germ cell tumors, with up to 3% being mediastinal. The low incidence, along with a nonspecific clinical presentation, complicates initial diagnosis and leads to delays in diagnosis and the initiation of specific treatment. Primary care plays a crucial role in detecting such tumors and in patient routing. At the outpatient stage, the patient should be examined and referred to a specialized facility for specific treatment as quickly as possible. For differential diagnosis at the initial stages between mediastinal germ cell tumors and lymphoproliferative diseases, mediastinal sarcomas, thymomas, and others, monitoring tumor markers is necessary: alpha-fetoprotein (AFP), beta-human chorionic gonadotropin (beta-HCG), and lactate dehydrogenase (LDH). When these markers are elevated and time is critical, it is permissible to start specialized antitumor treatment without histological confirmation.Currently, it is also important to consider the role of the new coronavirus infection, which complicates differential diagnosis at the initial stages. This article presents a clinical case of late detection of a germ cell tumor and attempts to conduct systemic therapy in the context of the disease’s complicated progression.

Pregnancy-related hormonal changes and thyroid growth: do they have an impact on the higher incidence of differentiated thyroid cancer in women?

To analyze whether pregnancy could play a role in the higher prevalence of differentiated thyroid carcinoma (DTC) in women. Estrogens strongly modify thyroid economy by increasing iodine clearance, thyroid hormone requirement and production. Human chorionic gonadotropin (hCG) contributes to the increased thyroid hormone synthesis. Both estrogens and hCG can interfere with the regulation of thyroid volume and with thyroid nodule development and progression. The potential effect of hCG is exclusively related to its weak agonistic activity on TSH receptor. Estrogen implication on normal and nodule-derived thyrocyte growth has been demonstrated in vitro and in animal models. Furthermore, there is solid clinical evidence showing a promoting effect of pregnancy on thyroid volume and nodule development. Two metanalysis, one including retrospective and another prospective observational studies, failed to show an association between pregnancy and DTC. A large pooled prospective analysis using multivariable-adjusted Cox proportional hazard models did not demonstrate an association between DTC and parity. Similarly, no association between PTC occurrence and parity was observed in a prospective cohort analysis by linkage to the statewide Surveillance, Epidemiology, and End Results (SEER). The presently available evidence does not support an involvement of pregnancy in DTC etiology.

Effect of progesterone concentration on hCG trigger day on clinical outcomes after high-quality single blastocyst transfer in GnRH antagonist cycles.

To investigate whether progesterone levels on the human chorionic gonadotropin (hCG) trigger day are associated with clinical outcomes in fresh cycles and the first frozen-thawed cycles (the freeze-all strategy) following the transfer of a high-quality single blastocyst. This single-center retrospective analysis was conducted on patients undergoing in vitro fertilization with the gonadotropin-releasing hormone (GnRH) antagonist protocol from January 2017 to December 2023. The study included the first and second oocyte retrieval cycles with progesterone levels ≤2 ng/ml on hCG trigger day. Clinical pregnancy rates and early miscarriage rates were compared among groups using curve fitting, threshold effect analysis, and multivariable regression. When progesterone levels were between 1 and 2 ng/ml, the pregnancy rate in fresh cycles was only 51% of that in cycles with progesterone levels ≤1 ng/ml (95% CI: 0.33, 0.79, p = 0.0028). And the pregnancy rate decreased by 25% (95% CI: 0.51, 1.09) for frozen cycles, although there was no statistically significant (p = 0.1273). When cycle types were used as a binary variable in multivariate regression analysis, it was found that the clinical pregnancy rate in frozen cycles was 1.84 times higher than in fresh cycles (OR = 1.84, 95% CI: 1.38-2.47). For progesterone levels between 1 and 2 ng/ml, the clinical pregnancy rate in frozen cycles was 2.90 times that of fresh cycles (OR = 2.90, 95% CI: 1.59, 5.29, p = 0.0015). Progesterone levels on hCG day had no impact on the clinical pregnancy rate in thaw cycles, nor did they affect miscarriage rates in fresh or thaw cycles (p > 0.05). When progesterone levels on hCG trigger day were between 1 and 2 ng/ml, the clinical pregnancy rate for frozen-thawed cycles of high-quality single blastocyst transfer using an GnRH antagonist protocol significantly surpasses that of fresh cycles, thus elective frozen embryo transfer after the freeze-all strategy is recommended.

Unexpected early pregnancy during myomectomy followed by successful term delivery: A case report.

Leiomyoma, also known as uterine fibroid, is a non-malignant tumor originating from the uterus's smooth muscles. It is the most common benign tumor in the female genital tract, exhibiting varying size and form that can distort the uterus's shape. Uterine fibroids affect 2.7-10.7% of pregnant women and can lead to increased risks during pregnancy, such as miscarriage, placental abruption, preterm labor, and fetal malpresentation. Myomectomy is a surgical intervention for uterine fibroids, but it has drawbacks, including hemorrhage, fever, infection, ureter ligation, adhesive disorders, and unplanned hysterectomy. In this case report, we present a 32-yr-old woman with a large leiomyoma who underwent laparotomy myomectomy due to abdominal pain and heavy menstrual bleeding. 4 wk after the myomectomy, she was referred to the Obstetric Clinic of Ayatollah Taleghani hospital, Tehran, Iran complaining of delayed menstruation. Her beta-human chorionic gonadotropin test was positive. Ultrasound revealed a fetus with an estimated gestational age of 6 wk and 4 days. The pregnancy continued with no complications. At 38 wk of gestation, she underwent a cesarean section and delivered a healthy newborn. This case report supports previous publications that have demonstrated the safety of myomectomy during pregnancy.

Drug treatment of true gynecomastia in overweight adult men

BACKGROUND: True gynecomastia is associated with excess body mass, which is caused by an imbalance of androgens/estrogens. Therefore, there is an interest in evaluating the possibility of drug therapy for this condition through the use of antiestrogens or aromatase inhibitors.AIM: To evaluate the possibility of drug therapy for true gynecomastia in adult men with excess body mass through the use of clomiphene or letrozole.MATERIALS AND METHODS: A retrospective study included men with newly developed gynecomastia and excess body mass who sought medical help at the Endocrinology Research Center from January 2020 to May 2024, and received either clomiphene therapy or letrozole for a period of 4 weeks. All patients were evaluated for the condition of their breast glands, total bilirubin, liver transaminases, creatinine, urea, luteinizing hormone, prolactin, sex hormone-binding globulin, estradiol, total testosterone, alpha-fetoprotein, and chorionic gonadotropin. The baseline level of statistical significance was set at p&lt;0.05.RESULTS: With clomiphene treatment, no statistically significant differences were found in the evaluated parameters, except for estradiol and testosterone levels, which increased. Clomiphene therapy worsened the condition of three patients (13% (95% CI 2,8;33,6)) - they experienced breast pain that was not present at the time of prescription. With letrozole treatment, there was a positive trend - all evaluated parameters significantly improved. Comparing the changes in the studied parameters, it was found that letrozole treatment had a better effect in terms of the severity of gynecomastia (-1[0;-1] degree), reduction in estradiol levels (-31,7[-8,8;-90,8] pmol/l), and also reduced the number of patients willing to undergo surgical removal of gynecomastia (-63,4% (95% CI -46,9;-77,9)).CONCLUSION: The use of an aromatase inhibitor reduces the severity of gynecomastia and decreases the number of patients willing to undergo surgical removal.

Rare forms of ectopic pregnancy in the rudimentary horn and ovary. How not to miss the main thing?

This article presents two cases of ectopic pregnancy in the ovary and rudimentary horn, which had a life-threatening course. Despite availability of modern high-quality diagnostics, determining the condition remains challenging, because the definitive diagnosis is established and confirmed only intraoperatively. Hence, the clinical picture can be used primarily in making a diagnosis and choosing an appropriate treatment strategy. Rare localizations, such as in the ovary and rudimentary horn, which cause difficulties in making a diagnosis, should not be overlooked. If an ectopic pregnancy is not detected promptly and the risks are underestimated, death may occur. Two clinical cases clearly demonstrate timely diagnosis, regardless of additional examination methods (e.g., pelvic ultrasound, human chorionic gonadotropin test), and adequate choice of access and scope of surgical intervention. Moreover, the lack of awareness among women about this type of pathology should be considered. Patients often do not complain, do not remember the date of their last menstruation, do not monitor their menstrual cycle, and do not seek medical help in a timely manner. The combination of several factors can lead to fatal events. In this study, both cases of ectopic pregnancy with a rare localization ended favorably.

8462 Synergistic Outcomes Of hCG And GLP1-RA Combination Therapy: Improved Body Composition And Carbohydrate Metabolism

Abstract Disclosure: F. Comite: None. K. O'Malley: None. Objective: Precision medicine prevents and reverses diseases of aging by way of systematic analysis of body composition and extensive blood biomarkers. Andropause, the age-related reduction of free testosterone (FT) in males, elicits symptoms primarily of muscle loss, decreased libido, and diminished energy. Exogenous testosterone therapy (TTx) subsequently increases lean body mass (LBM) and improves both libido and energy levels in affected males. More recently, stimulation of endogenous testosterone from the testes, human Chorionic Gonadotropin (hCG) has emerged as a compelling physiologic alternative to TTx. Common comorbidities to andropause are DMII and/or obesity. Recent literature surrounds the use of GLP-1 receptor agonists to improve insulin sensitivity in these disorders of carbohydrate metabolism. A primary benefit secondary to GLP-1 use is reduction of fat mass; however, concerns of this monotherapy surround loss of muscle.[1] Remarkably, when treated adjunctly with GLP-1s, hCG therapy significantly mitigates muscle loss while maintaining optimal carbohydrate biomarkers. The efficacy and benefits of hormonal optimization through hCG therapy simultaneous to GLP-1 intervention were investigated. Methods: In this retrospective analysis, a cohort of 20 males ≥30 years of age were reviewed at baseline timepoints and 18 months post treatment-initiation. Participants underwent biweekly hCG and weekly GLP-1 subcutaneous injections. Exclusion criteria restricted use of alternative GLP-1/GIP combination medication. Paired T-Tests were used to determine a relationship between LBM, FT, percent body fat (PBF), fasting glucose (FG), fasting insulin (FI), and HbA1c at each timepoint. Results: Body composition analysis as shown via bioelectrical impedance proved baseline PBF (mean=24.60) significantly reduced post-treatment (p&amp;lt;0.05, mean=18.08) for all participants. In addition, relevant carbohydrate metabolic biomarkers FG, FI, and HbA1c provided significant reductions (p&amp;lt;0.05). Initial FT (mean=67.76) and LBM (mean=150.36) increased significantly at follow-up (p&amp;lt;0.05) with values of 167.55 and 154.91, respectively. Discussion: Using metrics of precision medicine, our interpretation reveals a promising combination therapy for males experiencing andropause. The novel use of hCG to optimize FT levels enhances muscle, while simultaneously, fat loss and reversal of harmful carbohydrate metabolic markers resultant from GLP-1 therapy are achieved. Muscle loss due to overall weight loss is thus ameliorated. Our findings merit further investigation of the magnitude of downstream improvements, particularly in energy and libido.

8764 A Unique Case of Infertility in a Patient with NCCAH

Abstract Disclosure: M. Paravastu: None. R. Patel: None. Background: Non-Classic Congenital Adrenal Hyperplasia (NCCAH) in women often presents with hirsutism, acne, menstrual dysfunction, or infertility. Subfertility in patients with NCCAH can be attributed to menstrual disorders including oligomenorrhea or secondary amenorrhea. We report a unique case in which a patient with NCCAH with consistently normal menstrual cycles is experiencing infertility. Case Description: A 31 y/o female with no PMH was referred to our Endocrinology Clinic for evaluation of Infertility and elevated 17-Hydroxyprogesterone levels (17OHP). Patient has been having trouble conceiving for the past 2 years, no prior successful pregnancies. She started menstrual cycles at age 17, she reports having regular menstrual cycles. Prior to our evaluation, she was seen in Reproductive Endocrinology who completed hormonal and imaging evaluation. Elevated 17OHP: 286ng/dL. Rest of hormonal workup within normal range. Normal Pelvic Ultrasound. Hormonal workup was repeated in our clinic. 17OHP is elevated at 617.01ng/dL. Rest of lab work returned normal with DHEAS:218.9mcg/dL, TSH: 2.826mcUnits/mL, Free Testosterone: 5.4pg/mL, Prolactin:11.7ng/mL, Beta HCG: negative, LH: 13.5mUnits/mL, FSH: 5.3mUnits/mL, Estradiol 79pg/mL. Cosyntropin stimulation test was completed. Baseline AM 17OHP:469.78ng/dL, Baseline Cortisol: 17.9mcg/dL. 17OHP 30 minutes-post:1216.4ng/dL, Cortisol 30 minutes-post: 18.5mcg/dL. 17OHP 60 min-post: 1051ng/dL, Cortisol 60 minutes post:16.4 mcg/dL. Given Inconclusive Cosyntropin stimulation test results, Genetic Testing was recommended. Genetic testing returned positive for NCCAH, patient’s husband is not a carrier of this gene. She was started on Hydrocortisone therapy for treatment of infertility. Shortly after she started on hydrocortisone therapy, patient did successfully conceive, however the pregnancy later resulted in a miscarriage. Conclusion: Subfertility in patients in NCCAH is thought to be due to menstrual irregularities including oligomenorrhea or secondary amenorrhea. We report the first case of a woman with diagnosis of NCCAH who is experiencing infertility despite having normal menstrual cycles. Presentation: 6/1/2024

7426 Tamoxifen-Induced Ovarian Hyperstimulation in a Pre-Menopausal Patient with Breast Cancer History: Spontaneous Resolution with Conservative Management

Abstract Disclosure: S. Gondi: None. M. Contento: None. A. Leiter: None. Background: Tamoxifen is a selective estrogen receptor modulator (SERM) that competitively binds to estrogen receptors (ER) on tumors and inhibits the effect of estrogen, which is used in the treatment and prevention of ER-positive breast cancer. Tamoxifen therapy has been reported to increase serum estrogens and cause ovarian hyperstimulation in premenopausal women, but knowledge on how to manage these conditions is limited. Clinical Case: A 36-year-old pre-menopausal female with history of malignant neoplasm of the right breast (ER positive) who completed neoadjuvant chemotherapy, lumpectomy, and radiation, on tamoxifen for seven years presented with new-onset oligomenorrhea. Laboratory testing done by the patient’s gynecologist revealed total estrogen 2,723 pg/mL (reference range [RR] 34-501), testosterone 132 ng/dL (RR 8-60), anti-Mullerian hormone 12.7 ng/mL (RR for age 0.66-8.75), ovulation-phase follicle stimulating hormone 11.5 mIU/mL (RR 4.7-21.5) and luteinizing hormone (LH) 63.3 mIU/mL (RR 14-95.6). Further workup revealed that ovarian tumor markers alpha-fetoprotein and serum human chorionic gonadotropin and other labs including dehydroepiandrosterone sulfate, progesterone 17-OH, lactate dehydrogenase, prolactin, and thyroid stimulating hormone were normal. Transvaginal ultrasound (TVUS) showed a new 2.8 x 1.9 x 2.3 cm complex left ovarian cyst, which, along with the elevated estrogen level, was concerning for ovarian hyperstimulation. Treatment with LH-releasing hormone (LHRH) agonists, surgical consultation, and discontinuation of tamoxifen were offered as potential management strategies, but the patient opted for observation and continued tamoxifen. Two months later, estradiol was 989 pg/mL (RR 85-498), and then three months later decreased to 152 pg/mL with repeat TVUS showing resolution of the left ovarian cyst. The patient’s oligomenorrhea resolved with resumption of regular menstrual cycles. Conclusion: While it is well-known that tamoxifen causes elevated serum estrogen levels and can lead to ovarian hyperstimulation, there is limited research on the management of these side effects. Treatment strategies in past cases have included oophorectomy or medical management with LHRH agonists or gonadotropin-RH agonists. However, this case demonstrates that a tamoxifen-induced ovarian cyst and high estrogen levels can resolve on its own with continued tamoxifen treatment. Conservative management with monitoring via imaging and repeat estrogen levels may be sufficient in management of pre-menopausal women with tamoxifen-induced ovarian hyperstimulation. Presentation: 6/1/2024

Evaluation of Synthetic GnRH-Analog Peforelin with Regard to Oocyte Differentiation and Follicular Development in C57BL/6J Mice.

In biomedical research, ovulation induction is a critical step in the reproductive biology of laboratory animals. This study evaluates the efficacy of peforelin, a synthetic gonadotropin-releasing hormone (GnRH) analog, in comparison to pregnant mare serum gonadotropin (PMSG, synonym: eCG), traditionally used for ovulation induction in mice. PMSG is derived from the serum of pregnant horses, and its production is becoming increasingly problematic due to animal welfare concerns and regulatory restrictions. The aim of this study was, therefore, to evaluate an ethically acceptable and less invasive alternative to PMSG. Female C57BL/6J mice, aged 3-4 weeks, were divided into two groups to receive either peforelin at three different concentrations or PMSG, followed by an injection of human chorionic gonadotropin (hCG) to induce ovulation. Key outcomes included the number and quality of oocytes collected, fertilization rates, ovary morphology, and follicular differentiation. Although the number of oocytes was significantly lower in the peforelin cohort, the fertilization rate was high. Ovarian morphology was not significantly altered compared to the PMSG cohort. This study showed that peforelin is suitable for superovulation in mice. These results suggest that peforelin could be an ethically acceptable alternative to PMSG stimulation for inducing superovulation in mice.

Understanding the effect of acupuncture on nausea and vomiting during pregnancy from a metabolic perspective: study protocol for a single-blinded randomized controlled trial

BackgroundAcupuncture is an effective complementary therapy for nausea and vomiting during pregnancy (NVP). Nevertheless, the utilization of acupuncture for NVP has been minimally explored in current scholarly research, with a paucity of systematic randomized clinical trials (RCTs) in it. We aim to evaluate the effects of acupuncture on NVP after assisted reproductive techniques (ART) and explore the metabolism-related mechanism of the efficacy.MethodsThis single-blind, randomized, controlled trial will randomize 68 patients with NVP after ART to a traditional acupuncture (tACP) or a sham acupuncture (sACP) group. The tACP group will receive tACP thrice a week for 2 weeks with a day interval between sessions, while the sACP group will undergo the same number of nonpenetrative acupuncture at non-acupoints for the same period. Pregnancy-specific quantification of emesis will be used to evaluate symptom severity. Routine blood and urine tests, liver and kidney function tests, human chorionic gonadotropin, nuchal translucency thickness, and embryonic development measured using ultrasound will be used to evaluate safety during pregnancy. Non-targeted metabolomic analysis will be performed to explore the association between metabolic changes and clinical symptoms.DiscussionThis study will elucidate the effects and safety of acupuncture in treating NVP in women undergoing ART. The results of this study will contribute to optimizing acupuncture therapies by combining the body and auricular points and exploring the underlying therapeutic mechanism using a metabolomics approach.Trial registrationChinese Clinical Trial Registry, ChiCTR2300075259.

B-032 Evaluation of Assay Performance for Atellica CI 1900 analyzer in Routine Chemistry, Division of Laboratory Medicine, UMMC

Abstract Background The Atellica® CI 1900 (Siemens Healthiness) is a stand-alone, integrated clinical chemistry and immunoassay analyzer. Method verification has been done on this analyzer for 14 parameters based on the guideline of the Clinical and Laboratory Standard Institute (CLSI). Methods The method evaluation protocol consisted of determination of imprecision based CLSI EP 15-A3; CLSI EP06-A2 protocol was used for verification of linearity and method comparison was carry out in between Atellica® CI 1900 with our current Atellica® Solution based on CLSI EP09-A2 protocol. Method comparison data was analyzed by using statistical software, MedCalc. The data were used to calculate bias for Sigma metrics determination. Results Total of 14 analytes including sodium, potassium, chloride, creatinine, urea, alkaline phosphatase, total bilirubin, triglyceride, uric acid, glucose, thyroid stimulating hormone, free-thyroxine, human chorionic gonadotropin and carcinoembryonic antigen were tested. The results showed the repeatability and total imprecision were within acceptable limit as per manufacturer claims for all analytes. It was demonstrated that the analytical system operates within the claimed linearity ranges as stated in the information for use (IFU). Passing - Bablok analysis show the bias for all analytes were within our laboratory pre-set quality specification. The intercept and slope with 95% CI for Passing-Bablok analysis as shown in table 1. Sigma metrics were determined for each assay using the coefficient variation determined from precision study and bias obtained from the method comparison study. It showed that the Sigma for 14 analytes ranging from 3 to more than 6 with more than 93% assay has sigma scores more than 4. Conclusions Atellica® CI 1900 shows acceptable precision and bias for all analytes that evaluated. The analyser is fully comparable with Atellica® Solution. We conclude that Atellica® CI 1900 demonstrates good performance capabilities, making this analyzer suitable for low-to-medium volume laboratory.

A-337 The Utility of Urinary Human Chorionic Gonadotropin Testing in the Emergency Department

Abstract Background Human chorionic gonadotropin (hCG) levels are measured in both urine and blood as an indication of suspected pregnancy, and assessment of progress of conception. It is also measured in the investigation of patients presenting with acute abdomen and suspected of ectopic or molar pregnancy. This study reviewed the utility of urine pregnancy test in a large university teaching hospital. Methods Results of all urinary hCG tests (using hCG Combo Pregnancy kit, MEDLINE, IL) performed as point of care in the emergency department during the year 2023 were obtained. Corresponding plasma hcG levels performed (Total β-HCG Alinity immunoassay, Abbott Diagnostics, IL) were also obtained. Analysis of hCG testing outcomes were assessed. Results A total of 2848 urinary hCG tests were performed during the study period. The majority 2113 (74.2%) of samples were negative for hCG whereas 835 samples (29.3) were positive. Among the positive hCG urine samples, 401 patients (48%) had plasma hCG requested and performed. Plasma hCG values ranged from &amp;lt; 2.4 (26.5) to 219,462.5 mIU/mL (median 16,872.35 mIU/mL). One plasma sample with corresponding positive urinary hCG result had plasma hCG level &amp;lt;2.4 mIU/mL which is below the detection limit of the assay suggesting a false positive urinary hCG result. Among the 13 patients with serial plasma hCG values, only one patient exhibited doubling (48 hours) hCG values when less than 13,000 mIU/mL. One patient had a declining serial hCG plasma values suggesting failing conception. The remaining patients with consecutive plasma hCG values cannot be assessed as either the time gap was excessive or hCG values were markedly elevated (&amp;gt; 30,000 mIU/mL). Conclusions Although the utility of urinary hCG testing in the emergency department appeared appropriate, unnecessary repeat analysis with appropriate plasma request represented 3.2%. An electronic test request duplicate notification may help resolve this unnecessary repeat.

B-144 Sigma Metrics for Vitros Reproductive Endocrinology Assays Across Multiple Fluid Levels

Abstract Background Sigma metrics assess laboratory quality by incorporating precision, accuracy and total error allowed (TEa). Sigma metrics report quality on a scale of 0 to 6, with 6 representing the World-Class quality. QuidelOrtho developed a novel approach using big data analytics for the objective and automated calculation of Sigma metrics across thousands of Vitros® Analyzers running in real laboratory conditions. This approach was previously used to report the Sigma metric performance for 115 assays using data from 2022. A limitation of that study is the metrics were reported for a single fluid that was selected for medical relevance. However, reproductive endocrinology assays have complex medical utilization and there is a benefit to understanding Sigma metrics at multiple levels. The aim of this poster is to provide additional data on the Sigma metrics for reproductive endocrinology assays. Methods The methods follow the previous approach using the same Python algorithm to extract QC data from Jan. to Aug. 2022 (inclusive). Up to seven QC fluid lots were selected for each analyte. Metrics were calculated for each set of QC data that originated from a single analyzer, reagent lot and calibration curve; the median Sigma metric is reported in the Results. Proficiency testing limits were utilized as TEa limits where available, with preference to CLIA 2024 limits. Results Sigma metrics are reported for multiple fluids for the following assays: estradiol, follicular stimulating hormone, luteinizing hormone, progesterone, prolactin, testosterone, human chorionic gonadotropin, and thyroid stimulating hormone. All fluids examined report Sigma metrics greater than 4, which is considered “Good” performance. An exception is luteinizing hormone which has Sigma metrics = 1.9 at the lowest reported concentration. Conclusions Vitros reproductive endocrinology assays report strong Sigma metrics across multiple concentrations, indicating they are highly capable of achieving results within the allowable error.

B-113 Beckman Coulter DxI 9000 immunoassay analyzer assay performance meets new CLIA 2024 performance goals with highest proportion of Six Sigma performance amongst all major manufacturers

Abstract Background The Clinical Laboratory Improvement Act (CLIA) proficiency testing (PT) criteria will be updated in July 2024 with some goals tightening by up to 40%. It is assumed, but not known, that all assays and instruments will be able to achieve these goals. Using these new CLIA 2024 goals, estimates of current instrument group performance from an international proficiency testing (PT) survey have shown significant differences in quality, calling into question which assays can achieve the new CLIA goals. Currently, the highest performing diagnostic instrument achieves only 35.2% 6-Sigma, while the majority of instruments have less than 15% 6-Sigma performance indicating a higher probability of future PT failures. Methods Eighteen assays that will be governed by new CLIA 2024 goals were assessed for Sigma metric performance on the DxI 9000 immunoassay analyzer: Alpha Fetoprotein (AFP), Beta hCG, Carcinoembryonic antigen (CEA), Cortisol, Creatine Kinase MB (CK-MB), Estradiol, Ferritin, Folate, Follicle-Stimulating Hormone (FSH), Prolactin, Para-thyroid hormone (PTH), Total Prostate specific antigen (Total PSA), Testosterone, Thyroid Stimulating Hormone (TSH), Total Triiodothyronine (TT3),high sensitivity Troponin I, Total Thyroxine (TT4) and Vitamin B12. Precision and bias were determined following CLSI EP5 and EP9 guidelines, measured across 3 reagent lots. CLIA 2024 PT criteria provides the allowable total error for the standard Sigma-metric calculation: Sigma-metric = (TEa - |bias|) / SD Performance of the other major analyzers was assessed using the methodology introduced in 2006 by Westgard JO and Westgard SA. The Sigma-metric predicts future problems with PT and potential optimization of QC procedure opportunities, including fewer Westgard Rules, control levels, even reduced QC frequency and materials leading to less cost and time saved. Results Half (50%) of the assays on DxI 9000 achieves 6-Sigma, outperforming all other major manufacturers in the market who range from only 5% to 35% 6-Sigma. Further, over 78% of the DxI 9000 performance was 4Sigma and higher. Less than 8% of performance fell below 3-Sigma, which was observed at the extreme ends of the reportable range. Conclusions The DxI 9000 assay performance is well designed to meet CLIA 2024’s new PT criteria and has the highest prevalence of 6-sigma assay performance observed on market when compared to the top 5 major instrument manufacturers. Assays with Sigma metrics at 4-Sigma and higher are unlikely to face analytical PT difficulties and can be optimized for reduced Westgard Rules, control levels, and potentially even QC frequency.