Consistency in treatment effects and statistical significance between early-stage pregnancy endpoints and live birth in randomized controlled trials of infertility: a systematic meta-epidemiological study.

Importance: Live births are the 'gold standard' for assessing infertility treatments but are less frequently reported than clinical pregnancy. Identifying approaches to interpret randomized controlled trials (RCTs) without live birth data is essential.

Objective: To evaluate the correlation between treatment effects and the consistency of statistical significance in conclusions drawn from live birth versus early-stage pregnancy endpoints (an umbrella term defined as biochemical, clinical, or ongoing pregnancy) in RCTs reporting both outcomes.

Weighing Parenthood Wishes: A Conjoint Analysis of Criteria to Prioritize Infertile Couples for Publicly Funded Fertility Treatment.

BackgroundParenthood is a key life goal for many, but infertility affects about 1 in 6 globally. While fertility treatments offer solutions, their high costs limit access. Many health systems provide public funding, yet budget constraints prevent fully funded access, often leaving patients with significant out-of-pocket costs.

Considering minimal clinically important differences in assisted reproductive technology.

Objective: To address the reporting of minimal clinically important differences (MCIDs) in the published literature and investigate the utility of absolute and relative differences when defining this parameter.

Design: Expert opinion.

Subjects: Not applicable.

Recommendation to improve the rigor and impact of nonrandomized studies of interventions in fertility treatment research.

Objective: To provide a framework for conducting rigorous nonrandomized studies of interventions in fertility treatment research, addressing their role as complements to randomized controlled trials (RCTs) in evaluating treatment outcomes.

Design: Multidisciplinary expert consensus on best practices for nonrandomized studies of interventions, informed by advancements in novel methodologies, including causal inference.

Subjects: Patients undergoing assisted reproductive technologies (ARTs) procedures, such as ovarian stimulation, laboratory techniques, and embryo transfer.

Up-regulated microRNAs in blastocoel fluid of human implanted embryos could control circuits of pluripotency and be related to embryo competence.

Purpose: The paper aims to investigate the biological role of microRNAs secreted by preimplantation embryo into the blastocoel fluid and to detect a distinctive molecular signature for identifying embryos with the highest implantation potential.

Methods: We carried on a multicenter retrospective study involving five European IVF centers. We collected 112 blastocoel fluid samples from embryos on day 5 post-fertilization, cultured individually, along with data on blastocyst grade and embryo transfer outcomes.

A video clip detailing the patient journey on the day of oocyte retrieval in addition to the standard of care: a randomized controlled trial.

Study Question: Can a video clip detailing the patient journey decrease women's anxiety on the day of their first oocyte retrieval?

Summary Answer: The video clip does not affect women's anxiety on the day of their first oocyte retrieval.

What Is Known Already: IVF triggers anxious reactions in women and men, with peaks of anxiety on the day of (especially the first) oocyte retrieval as shown by reliable questionnaires and biomarkers of distress. Several trials showed that videos with preparatory information reduce women's and men's anxiety for out-patient procedures.

The presence, clarity, and consistency of definitions in pregnancy outcomes in infertility trials: a systematic review.

Study Question: How frequently do infertility trials report live birth and pregnancy, and how consistently were their definitions reported?

Summary Answer: One-third of 1425 infertility trials published in the last decade reported live birth, with one in eight reporting clinical pregnancy, ongoing pregnancy, and live birth concurrently; absent, ambiguous, or heterogeneous definitions were common.

What Is Known Already: Absent or inconsistent outcome definitions in randomized controlled trials (RCTs) limit their interpretation and complicate subsequent evidence synthesis. While reporting live birth in infertility trials has been a long-running recommendation, the extent to which this is adhered to, and the temporal trend of adherence, is unclear.

Trial characteristics, geographic distribution, and selected methodological issues of 1425 infertility trials published from 2012 to 2023: a systematic review.

Study Question: What are the trial characteristics, geographic distribution, and selected methodological issues of randomized controlled trials (RCTs) in infertility published from 2012 to 2023?

Summary Answer: Of the 1425 infertility RCTs, over two-thirds focused on IVF, nearly two-fifths did not use pregnancy or live birth as the primary outcome, a third lacked a primary outcome, a half were unregistered, and just over half were conducted in China (22%), Iran (20%), or Egypt (10%).

What Is Known Already: RCTs are the main source of evidence on the effectiveness of interventions. Knowledge about RCTs in infertility from the recent past will help to pinpoint research gaps and prioritize the future research agenda.

International multistakeholder consensus statement on post-publication integrity issues in randomized clinical trials by Cairo Consensus Group.

The number of retractions of randomized clinical trials (RCTs) following post-publication allegations of misconduct is increasing. To address this issue, we aimed to establish an international multistakeholder consensus on post-publication integrity concerns related to RCTs. After prospective registration (https://osf.

Development and validation of a gonadotropin dose selection model for optimized ovarian stimulation in IVF/ICSI: an individual participant data meta-analysis.

Background: The ovarian response to gonadotropin stimulation varies widely among women, and could impact the probability of live birth as well as treatment risks. Many studies have evaluated the impact of different gonadotropin starting doses, mainly based on predictive variables like ovarian reserve tests (ORT) including anti-Müllerian hormone (AMH), antral follicle count (AFC), and basal follicle-stimulating hormone (bFSH). A Cochrane systematic review revealed that individualizing the gonadotropin starting dose does not affect efficacy in terms of ongoing pregnancy/live birth rates, but may reduce treatment risks such as the development of ovarian hyperstimulation syndrome (OHSS).

A Cost-Effectiveness Analysis of Gonadotropins Used for Ovarian Stimulation during Assisted Reproductive Technology Based on Data from the French Nationwide Claims Database (SNDS).

Objective: Various gonadotropins are used for ovarian stimulation (OS). This study investigated the cost-effectiveness of different gonadotropins based on real-world data from the French National Health Database (SNDS) over a 7-year follow-up of assisted reproductive technology (ART) treatments.

Design: Cost-effectiveness analysis of different gonadotropins based on real-world data from the SNDS was conducted.

Analytical Investigation of the Profile of Human Chorionic Gonadotropin in Highly Purified Human Menopausal Gonadotrophin Preparations.

Highly purified human menopausal gonadotropin (HP-hMG [Menopur, Ferring Pharmaceuticals, Saint-Prex, Switzerland]) contains a 1:1 ratio of follicle-stimulating hormone (FSH) and luteinizing hormone (LH). This analysis aimed to assess gonadotropin (FSH, LH and hCG) abundance in HP-hMG and clarify the source of hCG by assessing the presence of sulfated glycans, which are diagnostic for pituitary hCG forms due to their distinct glycosylation patterns. Additionally, the purity of each sample, their specific components, and their oxidation levels were assessed.

Gonadotropin Activity during Early Folliculogenesis and Implications for Polycystic Ovarian Syndrome and Premature Ovarian Insufficiency: A Narrative Review.

Female fertility depends on the ovarian reserve of follicles, which is determined at birth. Primordial follicle development and oocyte maturation are regulated by multiple factors and pathways and classified into gonadotropin-independent and gonadotropin-dependent phases, according to the response to gonadotropins. Folliculogenesis has always been considered to be gonadotropin-dependent only from the antral stage, but evidence from the literature highlights the role of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) during early folliculogenesis with a potential role in the progression of the pool of primordial follicles.

Circulating microRNAs as Non-Invasive Biomarkers in Endometriosis Diagnosis-A Systematic Review.

The aim of this systematic review is to assess the power of circulating miRNAs as biomarkers as a diagnostic tool in endometriosis. In endometriosis-suspected women with uncertain imaging, the only way to confirm or exclude endometriosis with certainty is currently laparoscopy. This creates a need for non-invasive diagnostics.

Effectiveness of recombinant human FSH: recombinant human LH combination treatment versus recombinant human FSH alone for assisted reproductive technology in women aged 35-40 years.

Research Question: According to real-world data, is recombinant human FSH (r-hFSH) combined with recombinant human LH (r-hLH) or r-hFSH alone more effective for women of advanced maternal age (AMA) in terms of live birth?

Design: Non-interventional study comparing the effectiveness of r-hFSH and recombinant r-hLH (2:1 ratio) versus r-hFSH alone for ovarian stimulation during ART treatment in women aged 35-40 years, using real-world data from the Deutsches IVF-Register.

Results: Overall clinical pregnancy (29.8%, 95% CI 28.

Dose accuracy of the follitropin alfa pen injector 2.0, the follitropin alfa:lutropin alfa 2:1 combination pen injector 2.0 and the choriogonadotropin alfa pen injector 1.0 used for fertility treatment.

Background: This study aimed to confirm that the incremental dose/clicks system dispenses accurate doses for the Merck family of fertility pen injectors.

Research Design And Methods: Set doses (V) for three dose dial settings (minimum dose [V], midpoint dose [V] and maximum dose [V] for the follitropin alfa, choriogonadotropin alfa [D2 classification: single use/variable dose], and follitropin alfa:lutropin-alfa 2:1 combination pen injectors) or a single V for the choriogonadotropin alfa (D1 classification: single use/single dose) were assessed. Last dose administered by the multi-dose device was assessed for the 900 IU, 450 IU, 300 IU and 150 IU follitropin alfa, and the 900:450 IU, 450:225 IU and 300:150 IU follitropin alfa:lutropin-alfa 2:1 combination pen presentations.