End In Miscarriage Research Articles

Statutory leave for early pregnancy loss: A comparative study

Pregnancy loss prior to fetal viability is a common experience for women worldwide – 1 in 4 pregnancies end in miscarriage. Increased recognition of the impact of such loss has put the issue of statutory leave in this context on the policy and legislative agenda in an increasing number of jurisdictions. This article seeks to help inform these debates by presenting the findings of a comparative study of jurisdictions which have introduced such leave. From this, the article identifies two main approaches: leave based on the sick leave model and leave based on the compassionate leave model. The article argues that both models have strengths and limitations. What works in each individual jurisdiction will depend, among other factors, on the way in which the jurisdiction in question addresses the issue of leave more broadly. However, regardless of the model adopted, the article argues that some form of statutory leave for miscarriage and other pregnancy loss should be introduced on the basis that such leave serves to reinforce the equality agenda, provides a chance for care and recovery following pregnancy loss, and serves an important expressive and educative goal in ensuring better understanding of the impact of pregnancy loss on those who experience such loss.

Biochemical markers for prediction of the first half pregnancy losses: a review.

26% of all pregnancies end in miscarriage, and up to 10% of clinically diagnosed pregnancies, and recurrent pregnancy loss is 5% among couples of childbearing ages. Although there are several known causes of pregnancy loss in the first half, including recurrent pregnancy loss, including parental chromosomal abnormalities, uterine malformations, endocrinological disorders, and immunological abnormalities, about half of the cases of pregnancy loss in its first half remain unexplained. The review includes observational controlled studies (case-control or cohort, longitudinal studies, reviews, meta-analyses), which include the study of biochemical factors for predicting pregnancy losses in the first half, in singlet pregnancy. The Newcastle-Ottawa Scale (NOS) was used to assess the research quality. Finally, 27 studies were included in the review, which has 134904 examined patients. The results of the review include estimates of β-human chorionic gonadotropin, progesterone, pregnancy-associated protein - A, angiogenic vascular factors, estradiol, α-fetoprotein, homocysteine and CA-125 as a predictors or markers of the first half pregnancy losses. It may be concluded that to date, research data indicate the unavailability of any reliable biochemical marker for predicting pregnancy losses in its first half and require either a combination of them or comparison with clinical evidence. A fairly new model shall be considered for the assessment of α-fetoprotein in vaginal blood, which may have great prospects in predicting spontaneous miscarriages.

Improving access, understanding, and dignity during miscarriage recovery in British Columbia, Canada: A patient-oriented research study.

Approximately 15%-25% of clinical pregnancies end in miscarriage, with more than 15,000 miscarriages occurring annually in British Columbia, Canada. Despite the significant rates of loss, research and health care services for pregnancy loss remain scarce in British Columbia. This study aimed to (1) aid miscarriage recovery through the identification and sharing of equitable pregnancy loss care practices and supports and (2) present policy recommendations to improve prenatal care guidelines and employment standards for pregnancy loss. This research took a patient-oriented methodological approach alongside people with lived/living experience(s) of miscarriage recovery in British Columbia to evaluate access to health care during pregnancy loss, societal understanding of miscarriage, and treatment options that foreground dignity. The mixed-methods design of this research included policy research on prenatal care guidelines, policy research on provincial and territorial employment legislation for bereavement leave, semi-structured interviews (n = 27), and a discovery action dialogue (n = 4). The findings of this research demonstrate the need for improved prenatal care guidelines for early pregnancy loss, follow-up care after a miscarriage, mental health screening and supports, and bereavement leave legislation. This article includes recommendations to improve equitable access to pregnancy loss care, bereavement leave legislation, and future research in this area.

How to Minimize Future Fertility Risks Associated with the Surgical Management of Miscarriage

Miscarriage is a distressing event that can have a profound and lasting impact on a woman’s physical and emotional well-being. Although the causes of miscarriage are not always clear, it is estimated that up to 20% of all pregnancies end in miscarriage. After a miscarriage, women may experience a range of emotions, including grief, guilt, and anxiety. In some cases, medical intervention may be necessary to remove any remaining tissue from the uterus, prevent infection, and reduce the risk of complications. Surgical management is often recommended for incomplete or recurrent miscarriage. However, traditional surgical procedures can lead to the development of intrauterine adhesions, which can cause further complications and fertility problems. Intrauterine adhesions occur when scar tissue forms inside the uterus, usually as a result of damage to the uterine lining. This can cause the walls of the uterus to stick together, making it difficult for a fertilized egg to implant and grow, and potentially leading to infertility. To minimize the risk of intrauterine adhesions and preserve future fertility, ultrasound-guided manual vacuum aspiration (USG-MVA) has been developed as an alternative approach to traditional surgical management of miscarriage. USG-MVA is a minimally invasive procedure that involves using a handheld syringe to remove any remaining tissue from the uterus under ultrasound guidance. The use of ultrasound guidance ensures accurate catheter placement, leading to complete evacuation of the uterine contents and minimizing discomfort by reducing the number of suction catheters passes and unnecessary endometrial damage. USG-MVA has been shown to be a safe and effective method for managing miscarriages while preserving future fertility. The procedure is effective and can be performed in an outpatient setting, reducing the need for hospitalization, and minimizing associated costs. Additionally, USG-MVA has been found to have a lower risk of intrauterine adhesions compared to traditional surgical evacuation.

Yolk sac size and shape, Gestational sac size, and embryonic Heart Rate as prognostic factors of first trimester Pregnancy Outcome.

Background; Around 15-20% of pregnancies end in miscarriage. The yolk sac initially forms at around 5 weeks gestation and may be viewed via ultrasonography. Both the yolk sac and fetal heart rate can be utilized as predictors of first trimester gestation result, Aim and objectives; to determine the relationship between early abortion and each of the ultrasound characteristics measured during the first trimester (gestational sac size, yolk sac size, and fetus heart activity). Subjects and methods; This prospective cohort research was done on 200 pregnant women in their first trimester with a week of gestation of between 5 and 6 weeks at Al-Azhar University's department of obstetrics and gynecology. Result; According to the ultimate conclusion of ultrasonographic findings in the study group, 5 (2.5%) of the 34 fetus losses were missed abortions (fetal pole without detectable pulsations), 10 (5%) were blighted ovaries, 7 (3.5%) were partial miscarriages, and 12 (6%) were complete miscarriages. conclusion; During the first trimester of pregnancy, the monitoring of these characteristics (FHR, YS diameter and shape, and GS diameter) proven to be a great, useful, and non - invasive tool in the evaluation, prognosis, and follow-up of pregnant women. When the gestational sac diameter, CRL, and embryo heart rate were recorded all at the same time, they were able to determine the prognosis of the first trimester better than when each characteristic was used separately.

Adverse pregnancy and birth outcomes in sexual minority women from the National Survey of Family Growth

Few studies have examined how multiple marginalized identities are associated with adverse pregnancy and birth outcomes, especially for Black and Hispanic sexual minority women. Sexual minorities are people who identify as lesbian, gay, bisexual or transgender (LGBT). The purpose of this study was to examine differences in adverse pregnancy (i.e., miscarriage) and birth outcomes (i.e., preterm birth, low birthweight, and stillbirth) in a national sample of women by race and ethnicity, and sexual minority status (LGBT identification and same-sex sexual behavior). We conducted a cross-sectional analysis of the National Survey of Family Growth (NSFG). The unit of analysis was pregnancy, not participants. In this study, we examined pregnancies to participants who identified as heterosexual, lesbian, and bisexual, by race and Hispanic ethnicity. We also studied sexual behaviors to categorize participants as women who have sex with women (WSW) and women who have sex with men (WSM). Outcomes included preterm birth, low birthweight, miscarriage, and stillbirth. We employed logistic and linear regression analyses for analyses using STATA. We studied 53,751 pregnancies, and 9% of these occurred in people who identified as heterosexual, but had engaged in sexual activity with a female partner (heterosexual-WSW), 7% in those identifying as bisexual, and 1% to women who identified as lesbian. Pregnancies ended in preterm birth (10.7%) and low birthweight (9.0%), stillbirths (2-4%), and miscarriages (17-21%) in sexual minority women. We observed that pregnancies reported by Hispanic lesbian women had a higher birthweight (β = 10.71, SE = 4.1, p-value = 0.01) compared to infants born to Hispanic heterosexual-WSM. Pregnancies to lesbian women were significantly more likely to end in stillbirth (aRR = 3.58, 95% CI 1.30,9.79) compared to heterosexual-WSM. No significant differences were noted in risk of adverse birth outcomes by sexual orientation for NH Black or Hispanic women. In this sample, preterm births were less likely to occur among heterosexual-WSW than in heterosexual-WSM. Pregnancies to lesbians and bisexual women were more likely to end in miscarriage or stillbirth than heterosexual WSM. Lesbian Hispanic women reported higher birthweights compared to heterosexual-WSM Hispanic women. More research should be done to further understand these findings.

O-302 Lower expression of AHCY is associated with increased miscarriage risk

Abstract Study question Are alterations in the transcript levels of genes from the methionine cycle associated with maternal associated miscarriage risk? Summary answer Lower expression of AHCY is associated with a greater number of prior pregnancy losses What is known already Around 15% of pregnancies end in miscarriage, and the risk of recurrence increases with each pregnancy loss. Aberrant differentiation (decidualization) of endometrial stromal cells into specialised decidual cells to accommodate implantation is a key maternal factor for miscarriage risk. Our previous work identified secretory changes in cysteine and methionine metabolites upon decidualization. The methionine cycle contributes to vital cellular functions, including producing methionine for proliferation, regulating cell differentiation, and S-adenosylmethionine (SAM) production. SAM is required for protein, RNA and DNA methylation, thereby influencing pathways at the metabolic, epigenetic, and proteomic levels. AHCY clears S-adenosylhomocysteine (SAH), reducing its inhibition of methylation. Study design, size, duration Endometrial biopsies (n = 250) were collected during the luteal phase (LH + 6-11). Patients were grouped based on their miscarriage history. Accordingly, expression of genes from the methionine cycle were quantified using RT-qPCR. Participants/materials, setting, methods Endometrial biopsies were obtained, with written informed consent, from women attending the Implantation Clinic at University Hospitals Coventry and Warwickshire NHS Trust, following transvaginal ultrasounds to exclude uterine pathology. Isolated RNA was converted into cDNA. Expression of AHCY, AMD1, BHMT2, CBS, MAT2A, MAT2B, and MTR were normalised to L19. Statistical analysis was performed in Graphpad Prism; with significance accepted at p < 0.05. AHCY was silenced in an endometrial cell line to determine its effect on decidualization. Main results and the role of chance This study reports a distinct reduction in expression of methionine cycle genes (MAT2A, AHCY, AMD1, MTR, BHMT2) in the late-luteal phase of the cycle consistent with a reduction in proliferation. By plotting percentile graphs based on the statistical distribution in gene expression for each day of the luteal phase, comparisons have been made between groups. AHCY expression is significantly reduced in patients with increasing number of prior miscarriages, particularly between 0-2 and 5+ previous miscarriages (p = 0.0334). Neither patient age nor BMI are a factor in this reduced expression. In contrast, there is a stromal specific increase in AHCY upon decidualization in vitro, suggesting it is required in the decidua. Silencing AHCY in an endometrial cell line significantly reduces PRL expression upon decidualization. Reduction in AHCY may lead to a decreased “methylation potential” as SAH cannot be cleared. SAH accumulation inhibits methylation, and limits SAM production, thus compounding its effect. Decreased methylation potential could prevent differentiation of the stromal compartment, resulting in lower levels of PRL, and altering decidual timing. Therefore, an embryo may implant into a tissue primed for disintegration, resulting a miscarriage. In summary, AHCY may contribute to aberrant decidualization augmenting the risk of miscarriage. Limitations, reasons for caution Results are based on endometrial biopsies from an implantation clinic, therefore studies into biopsies from women with normal reproductive histories should also be analysed. Further functional studies are needed to ascertain the mechanism of action of AHCY in miscarriage. Wider implications of the findings This study identified that a decrease in AHCY in whole endometrial tissue is associated with increased risk of miscarriage. Further, silencing AHCY perturbed decidual marker expression. Thus, AHCY may act as a biomarker for atypical decidualization, and the clearance of SAH may be a potential treatment. Trial registration number N/A

Our Experience in Approaching and Managing Pregnant Ladies Infected with COVID 19 at Prince Ali Hospital in Jordan

Our experience in approaching and managing pregnant ladies infected with covid 19at Prince Ali hospital in Jordan. Introduction: A new type of coronavirus was discovered in Wuhan, China in late. In Jordan, the first case was declared on the third of March 2020. Concerns about its implication on pregnant women wellbeing although the presentation of the disease varies from mild to severe. Pregnant women are more likely to get infected by SARS-CoV-2. Material and Methods: This descriptive cross - sectional study among pregnant women was performed at Prince Ali hospital from June 2020 until January 2021. A sample (n = 100) was selected using convenience sampling. We used Microsoft Excel (version 16.0) for descriptive statistical analysis. We used counts (frequency) to describe nominal variables. Results: We managed 100 pregnant women with COVID-19 aged 21–39 years at the Prince Ali hospital between June 2020 and January 2021, out of 1000 pregnant women who were admitted during that period. Fifteen patients were in their 1st trimester (15%), 31 in their 2nd trimester (31%) and 54 in their 3rd trimester (54%). Among the 100 pregnant women with COVID-19 on admission, 66 patients (66%) were asymptomatic, and 34 patients (34%) were symptomatic. 91 pregnant women completed their pregnancy, resulting in a live birth. Four pregnancies- (4%) ends in miscarriage, no vertical transmission was observed. Caesarean sections were performed in 21 patients (21%) due to obstetric indications. No maternal deaths and no ICU admissions was among our hospitalised patients. Conclusion: Pregnant women with COVID-19 have a low risk of experiencing severe disease and a lower likelihood of having complications as we noticed in our study.

Early pregnancy loss: Invisible but real.

One of every five pregnancies ends in miscarriage, disputing the common misconception that miscarriage is rare. Early pregnancy loss has a complex impact on women's mental health, requiring compassionate, trauma-informed care. This article explores the emotional and psychological impacts of miscarriage, and strategies for nurses to support the needs of patients after a miscarriage.

Antidepressant use in pregnancy and severe cardiac malformations: Danish register-based study.

Studies restricted to live births may underestimate severe teratogenic effects. We address the limitation by including data from both prenatal and postnatal diagnoses of cardiac malformations. Register-based study. Denmark. 364012 singleton pregnancies from 2007 to 2014. We used data from five nationwide registries. Exposure to antidepressants was measured using redeemed prescriptions. Pregnancies with cardiac malformations that end in miscarriage, termination, stillbirth, postnatal death or cardiac surgery <1year of birth were classified as severe cardiac malformations (SCM). Propensity scores with adjusted prevalence ratios (PRs) were calculated. SCM were reported in 972 of 364012 pregnancies overall and in 16 of 4105 exposed. For venlafaxine, the PR for SCM was 2.13 (95% confidence interval [CI] 0.89-5.13), 1.73 (95% CI 1.08-2.77) for other cardiac malformations, and there was a cluster of hypoplastic left heart syndromes (HLHS) (crude PR 17.4 [95% CI 6.41-47.2]), none of which ended in a live birth. For HLHS, the absolute risk increase was 4.4/1000 and the number needed to harm was 225. For selective serotonin reuptake inhibitors, the PRs were 1.09 (95% CI 0.52-2.30) and 1.38 (95% CI 1.00-1.92) for SCM and other cardiac malformations, respectively. Pregnancy exposure to venlafaxine is associated with an increased risk of severe cardiac malformations but with a low absolute risk. Potential mechanisms include direct effects or confounding by indication. Venlafaxine exposure is a marker for risk pregnancies for which fetal echocardiography may be considered. Exposure to venlafaxine is associated with an increased risk of cardiac malformations but with a low absolute risk.

Methods for managing miscarriage: a network meta-analysis.

Methods for managing miscarriage: a network meta-analysis.

Association between vaginal microbiota and risk of early pregnancy miscarriage

Approximately 15 % of clinically recognized pregnancies end in miscarriage. To explore the vaginal microbiota profile in women diagnosed with early pregnancy miscarriage (including missed miscarriage [M] or empty-sac miscarriage [E]), the microbial community structure in vaginal fluid was evaluated by Illumina MiSeq sequencing of the 16S rRNA gene V4 region and compared with that in women with normal pregnancy (P). Taxa identified in samples from the P, E, and M groups formed distinct clusters. The M group had the highest bacterial species richness and diversity, with lower Lactobacillus levels and higher Bacteroides, Halomonas, Miscellaneous-Crenarchaeota, Bacillus, Staphylococcus, Escherichia/Shigella, and Acetobacter levels than in the other two groups. The vaginal community-state types differed significantly among the three groups (P = 0.02) but were similar between the P and E groups (P = 0.21). Moreover, we identified an optimal marker set composed of 12 operational taxonomic units based on a random forest model that distinguished the M and P groups, with areas under the receiver-operating characteristic curve of 86.76 % and 93.33 % in the training and test groups, respectively. In conclusion, this study highlights that patients with early pregnancy miscarriage had a significantly different vaginal microbiota profile. Microbial markers analyzed by RT-qPCR may be applied for the etiological diagnosis of miscarriage. Further studies should be performed to elucidate the possible mechanism of special strains affecting miscarriage during early pregnancy.

Treatment of Couples Experiencing Pregnancy Loss: Reauthoring Loss from a Narrative Perspective

ABSTRACT Pregnancy loss is a traumatic event that affects many families. 1 in 5 pregnancies end in miscarriage, and 1–2 out of every 100 births are stillbirths. Mothers report depression, shame, and guilt following a pregnancy loss. They also report a lack of social and emotional support, as Western culture tends to discourage mothers from grieving. Additionally, the impact on partners often goes unnoticed, as pregnancy loss is primarily framed as a birth parent’s issue. As couples struggle to deal with the emotions of pregnancy loss, many approach the process of grieving in ways that inhibit healing, which can negatively impact their relationship. Given the potential difficulties, many couples seek therapy to help them with the challenges that may follow pregnancy loss. However, there is a lack of literature that discusses how to systemically treat pregnancy loss. This article aims to address that gap by presenting a narrative approach to treating pregnancy loss. Narrative therapy is a natural fit when treating grieving couples as it allows them to coauthor their story of loss and coauthor a story of healing. Narrative therapy provides a space for couples to share their story, externalize problems related to the loss, find unique outcomes to support an alternative story, and solidify a new narrative related to their pregnancy loss.

Systems Pharmacology-Based Research on the Mechanism of Tusizi-Sangjisheng Herb Pair in the Treatment of Threatened Abortion.

Threatened abortion (TA) is a common complication with high incidence in the first trimester of pregnancy, which will end in miscarriage if not treated properly. The Chinese herbs Cuscutae Semen (Tusizi in Chinese) and Herba Taxilli (Sangjisheng in Chinese) first recorded in the ancient classic medical book Shennong Bencao Jing are effective and widely used as an herb pair for the treatment of TA, while the active ingredients and the functional mechanism of Tusizi-Sangjisheng herb pair treating TA are still unknown. In order to exploit the relationship between those two herbs and TA, systems pharmacology analysis was carried out in this study. A total of 75 ingredients of Tusizi-Sangjisheng were collected from Traditional Chinese Medicine System Pharmacology Database and Analysis Platform (TCMSP). 12 bioactive compounds were screened, and 153 directly related targets were predicted by systematic models. Besides, Gene Ontology (GO) enrichment analysis and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analysis were used to systematically explore the potential mechanisms of Tusizi-Sangjisheng treating TA. Meanwhile, Compound-Target (C-T), Target-Disease (T-D), and Target-Pathway (T-P) networks were constructed to further quest the underlying functional mechanisms of Tusizi-Sangjisheng. As a result, 31 targets and 3 key pathways were found to be directly related to TA that includes mitogen-activated protein kinases (MAPKs), phosphatidylinositol-3-kinase/protein kinase B (PI3K-Akt), and transforming growth factor-β (TGF-β) signaling pathways. The results in this study may provide some valuable clues about the molecular mechanisms of the efficient Chinese herb pair Tusizi-Sangjisheng in the treatment of TA.

Men living through multiple miscarriages: protocol for a qualitative exploration of experiences and support requirements

IntroductionUp to 1 in 4 pregnancies and 1 in 20 subsequent pregnancies end in miscarriage. Despite such prevalence the psychosocial effects are often unrecognised and unsupported. In the absence of...

Role of Maternal Age and Pregnancy History in Risk of Miscarriage: Prospective Register-based Study

(BMJ. 2019;364:I869) Miscarriage is unfortunately a relatively common pregnancy outcome. Various studies have reported that 12% to 15% of pregnancies end in miscarriage. However, these rates may not be accurate as some women experience miscarriage without ever realizing they were pregnant and differences exist among studies regarding the definition of miscarriage versus stillbirth. Several risk factors for miscarriage have been reported, but maternal age seems to have the strongest association. The youngest mothers have a slightly increased risk while older women have a much greater risk than younger women. There might also be an association between previous pregnancy complications and miscarriage risk. This population-based study aimed to evaluate the rate of miscarriage and its association with maternal age and pregnancy history among Norwegian women.

Partial Hydatidiform Mole and Coexistent Live Fetus: A Case Report and Review of the Literature.

Twin pregnancy of a hydatidiform mole with a coexistent live fetus is very rare, and complete molar pregnancy is involved in most cases. A partial molar pregnancy almost always ends in miscarriage due to a triploid fetus. Here, we report a case of a 32-year-old Chinese woman with ultrasound diagnosis of a partial molar pregnancy. Amniocentesis suggested mosaicism, but the fetus was morphologically normal. The woman chose to continue the pregnancy after fully understanding the risk. The infant was delivered prematurely, and the presence of a large single placenta with molar changes. The baby’s peripheral blood chromosomes were diploid, and the pregnant woman had no serious complications. The diagnosis, management, and monitoring of this condition will remain challenging because of its rarity. Partial hydatidiform mole combined with pregnancy can result in delivering of a normal fetus and live birth under proper management.

Early Miscarriage: Morphological Data Useful to Clinical and Nosographic Classification

The most frequent complication of the pregnancy is miscarriage. One in five pregnancies ends in miscarriage and the risk of recurrence increases with the increase of previous spontaneous abortions. In the present article an original checklist is shown to classify the causes of abortion based on morphological criteria that can be highlighted on abortive tissue. These histopathological elements are useful in distinguishing fetal from maternal causes of spontaneous abortions and those are used for a nosographic classification.

The hegemonic role of biomedical discourses in the construction of pregnancy loss

Background and problemPregnancy is constructed as a joy-filled and natural experience with a taken-for-granted expectation that the outcome will be a healthy baby. However, in South Africa approximately 1 in 4 pregnancies end in miscarriage and the stillbirth rate is 24 per 100 live births. Despite the overwhelming statistics, reproductive loss is considered a cultural taboo and continues to be silenced in various ways by the medical fraternity and society in general. AimOur study aimed to demonstrate the role that biomedical discourses play in shaping both women’s experiences of reproductive loss as well as how those close to them respond to these losses. The study was located within a social constructionist framework. MethodsSeven South African women were recruited via snowball sampling to participate in in-depth interviews. A discourse analysis was conducted to deconstruct hegemonic discourses implicit in the participants’ dialogues. FindingsThe adoption of medical framing of miscarriage and the social awkwardness of loss framed the participants talk about their miscarriages. Our study highlights the centrality of biomedical discourses in influencing both the experiences of our participants as well shaping social discourses. The adoption of the medical framing of miscarriage were identified in the following themes: no answers to first trimester miscarriage and the normalization of miscarriage. The social awkwardness of loss were identified as lack of cultural scripts, lack of acknowledgement and unhelpful words and actions. ConclusionThe paper highlights the power inherent in medicine and demonstrates how this hegemony pervades societal understandings of reproductive loss. Caught in this crossfire are grieving mothers with few alternatives in terms of their grief processes.

Physiological, hyaluronan-selected intracytoplasmic sperm injection for infertility treatment (HABSelect): a parallel, two-group, randomised trial

SummaryBackgroundSperm selection strategies aimed at improving success rates of intracytoplasmic sperm injection (ICSI) include binding to hyaluronic acid (herein termed hyaluronan). Hyaluronan-selected sperm have reduced levels of DNA damage and aneuploidy. Use of hyaluronan-based sperm selection for ICSI (so-called physiological ICSI [PICSI]) is reported to reduce the proportion of pregnancies that end in miscarriage. However, the effect of PICSI on livebirth rates is uncertain. We aimed to investigate the efficacy of PICSI versus standard ICSI for improving livebirth rates among couples undergoing fertility treatment.MethodsThis parallel, two-group, randomised trial included couples undergoing an ICSI procedure with fresh embryo transfer at 16 assisted conception units in the UK. Eligible women (aged 18–43 years) had a body-mass index of 19–35 kg/m2 and a follicle-stimulating hormone (FSH) concentration of 3·0–20·0 mIU/mL or, if no FSH measurement was available, an anti-müllerian hormone concentration of at least 1·5 pmol/L. Eligible men (aged 18–55 years) had not had a vasovasostomy or been treated for cancer in the 24 months before recruitment and were able, after at least 3 days of sexual abstinence, to produce freshly ejaculated sperm for the treatment cycle. Couples were randomly assigned (1:1) with an online system to receive either PICSI or a standard ICSI procedure. The primary outcome was full-term (≥37 weeks' gestational age) livebirth, which was assessed in all eligible couples who completed follow-up. This trial is registered, number ISRCTN99214271.FindingsBetween Feb 1, 2014, and Aug 31, 2016, 2772 couples were randomly assigned to receive PICSI (n=1387) or ICSI (n=1385), of whom 2752 (1381 in the PICSI group and 1371 in the ICSI group) were included in the primary analysis. The term livebirth rate did not differ significantly between PICSI (27·4% [379/1381]) and ICSI (25·2% [346/1371]) groups (odds ratio 1·12, 95% CI 0·95–1·34; p=0·18). There were 56 serious adverse events in total, including 31 in the PICSI group and 25 in the ICSI group; most were congenital abnormalities and none were attributed to treatment.InterpretationCompared with ICSI, PICSI does not significantly improve term livebirth rates. The wider use of PICSI, therefore, is not recommended at present.FundingNational Institute for Health Research Efficacy and Mechanism Evaluation Programme.