4.5 Editorial Material

Preface: Emerging importance of real world evidence in reproductive medicine

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Article Obstetrics & Gynecology

The Fischer protocol for assisted reproductive technology treatment: Real-world data experience comparing elective single versus double embryo transfer with or without comprehensive chromosome screening

Vera Baukloh et al.

Summary: This report presents real-life data from two clinics using the Fischer protocol for cycle programming in patients undergoing assisted reproductive technology (ART) treatment. The study found that ovarian stimulation using the Fischer protocol provides consistent and optimal ART outcomes. However, high rates of multiple implantation were observed, especially when transferring two embryos to patients aged over 39 years. Live birth rates were higher after comprehensive chromosome screening (CCS) compared to untested embryos. Therefore, the recommendation is to implement a single embryo transfer policy, particularly for women under 34 years of age with favorable ART treatment conditions.

BEST PRACTICE & RESEARCH CLINICAL OBSTETRICS & GYNAECOLOGY (2023)

Article Obstetrics & Gynecology

Intergenerational trends in reproduction: Infertility and pregnancy loss

Andrea M. F. Woolner et al.

Summary: This review article provides a summary of current evidence on intergenerational trends in infertility and pregnancy loss. Evidence suggests intergenerational trends between mothers and daughters for age at menopause, endometriosis, polycystic ovarian syndrome (PCOS), male factor infertility, and miscarriage. Limited evidence exists on a predisposition to stillbirth between mothers and daughters and on paternal transmission of risk. The majority of studies have significant limitations, highlighting the need for high-quality research to understand the heritability of infertility and pregnancy loss and its implications for clinical practice.

BEST PRACTICE & RESEARCH CLINICAL OBSTETRICS & GYNAECOLOGY (2023)

Article Obstetrics & Gynecology

Male infertility and gonadotropin treatment: What can we learn from real-world data?

Sandro C. Esteves et al.

Summary: Evidence-based gonadotropin therapy effectively restores spermatogenesis and fertility in male infertility disorders associated with hypogonadotropic hypogonadism. However, its use to improve fertility in men with idiopathic oligozoospermia or nonobstructive azoospermia remains controversial. Real-world data research suggests that gonadotropin therapy may be more effective in managing selected male infertility patients, with potential gains for all parties involved.

BEST PRACTICE & RESEARCH CLINICAL OBSTETRICS & GYNAECOLOGY (2023)

Article Obstetrics & Gynecology

Quality of clinical prediction models in in vitro fertilisation: Which covariates are really important to predict cumulative live birth and which models are best?

David J. McLernon et al.

Summary: The improvement in IVF cryopreservation techniques has led to an increase in elective single embryo transfer, reducing multiple pregnancy rates. Clinical prediction models are useful in estimating couples' chances of success and guiding future treatment. This review discusses different models for predicting cumulative live birth and recommends when and which models should be used.

BEST PRACTICE & RESEARCH CLINICAL OBSTETRICS & GYNAECOLOGY (2023)

Article Obstetrics & Gynecology

Live birth is not the only relevant outcome in research assessing assisted reproductive technology

Zheng Wang et al.

Summary: In assisted reproductive technology (ART) research, live birth is considered an important outcome but its interpretation can be misleading when solely focused on. This review presents an overview of the definitions of live birth and demonstrates through clinical examples the impact of variations in live birth on research findings, highlighting the importance of considering other outcomes such as multiple pregnancy, pregnancy loss, and maternal and offspring health outcomes. A holistic outcome assessment beyond live birth is necessary to inform evidence-based decision making in ART research.

BEST PRACTICE & RESEARCH CLINICAL OBSTETRICS & GYNAECOLOGY (2023)

Review Obstetrics & Gynecology

Association between the number of oocytes and cumulative live birth rate: A systematic review

Ana Raquel Neves et al.

Summary: The literature regarding the association between the number of oocytes retrieved and the cumulative live birth rate (CLBR) is conflicting. Some studies suggest a continuous increase in CLBR with more oocytes retrieved, while others find a plateau. The association between oocyte number and CLBR varies according to patients' age.

BEST PRACTICE & RESEARCH CLINICAL OBSTETRICS & GYNAECOLOGY (2023)

Article Obstetrics & Gynecology

Treatment algorithms for high responders: What we can learn from randomized controlled trials, real-world data and models

Panagiotis Drakopoulos et al.

Summary: A high ovarian response refers to a greater number of follicles and/or oocytes compared to a normal response. It can be diagnosed before oocyte pick-up when there are >18-20 follicles ≥11-12 mm, or after oocyte pick-up when >18-20 oocytes have been retrieved. Women with a high response are at high risk of ovarian hyperstimulation syndrome (OHSS). Appropriate management strategies, such as individualized gonadotropin dosing, monitoring, and choice of protocols, can greatly reduce the risk of high response.

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Article Obstetrics & Gynecology

Number of oocytes and IVF outcomes: Real-world evidence

Sesh K. Sunkara

Summary: Randomized controlled trials (RCTs) are the gold standard for studying the effect of interventions and establishing causal relationships. Real-world evidence (RWE) from real-world data (RWD) involves a heterogeneous patient population in real-world settings and provides complementary evidence to RCTs. This review examines the association between the number of oocytes following ovarian stimulation and IVF outcomes, shaping current IVF practices.

BEST PRACTICE & RESEARCH CLINICAL OBSTETRICS & GYNAECOLOGY (2023)

Article Obstetrics & Gynecology

Use of a recombinant human follicle-stimulating hormone:recombinant human luteinizing hormone (r-hFSH:r-hLH) 2:1 combination for controlled ovarian stimulation during assisted reproductive technology treatment: A real-world study of routine practice in the Russian Federation

Yulia Koloda et al.

Summary: Two observational studies in the Russian Federation examined the patient demographics and outcomes of ovarian stimulation using a combination of recombinant human follicle-stimulating hormone and recombinant human luteinizing hormone. The studies showed a clinical pregnancy rate of 30.4% per cycle and a live birth rate of 25.8% per cycle. No new safety concerns were reported.

BEST PRACTICE & RESEARCH CLINICAL OBSTETRICS & GYNAECOLOGY (2022)

Article Obstetrics & Gynecology

Real-world evidence analysis of the follicle- stimulating hormone use in male idiopathic infertility

Daniele Santi et al.

Summary: Male idiopathic infertility poses a challenge in infertility management. While FSH treatment has shown increased pregnancy rates, its indiscriminate use lacks clinical evidence in idiopathic infertility. Real-world data can provide valuable insights for optimizing treatment in male idiopathic infertility.

BEST PRACTICE & RESEARCH CLINICAL OBSTETRICS & GYNAECOLOGY (2022)