Weight Loss on IVF Outcomes in Overweight and Obese Infertile Women

Not Applicable

Completed

• Conditions: Infertility; Weight Loss; Obesity; IVF

• Registration Number: NCT07174817
• Lead Sponsor: Peking University People's Hospital

Brief Summary

The aim of this study is to determine whether weight loss prior to in vitro fertilization (IVF) improves live birth outcomes in overweight and obese infertile women. The study prospectively analyzed 158 overweight and obese (BMI ≥ 24 kg/m2) infertile women, age between 20 and 36 years, undergoing their first assisted reproduction treatment at the Reproductive Center of Peking University People's Hospital from January 2019 to December 2020. They were randomly allocated to two groups: one for weight loss intervention(dietary and exercise management) for 3 months prior to IVF and the other for control. All patients underwent standard ovarian stimulation, oocyte retrieval, and embryo transfer according to the local reproductive center protocol. Statistical analyses included descriptive statistics, logistic regression, and ROC curve analysis

Detailed Description

Background: Elevated body mass index (BMI) is associated with poorer outcomes in infertile women undergoing assisted reproductive technology (ART). However, evidence for effective weight loss interventions and their impact on live birth rates remains limited and inconclusive. The aim of this study is to determine whether weight loss prior to in vitro fertilization (IVF) improves live birth outcomes in overweight and obese infertile women.

Methods: This randomized controlled clinical trial enrolled 158 overweight or obese (BMI ≥ 24 kg/m²) infertile women undergoing their first ART cycle at the Reproductive Center of Peking University People's Hospital. Participants were randomly allocated to either a weight intervention group or a control group using a computer-generated randomization sequence. The intervention group received a structured program consisting of dietary modification and physical exercise for three months prior to the initiation of IVF. In contrast, the control group received standard clinical care and were advised to manage their weight independently. The primary outcome measure was the live birth rate.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Study First Submitted: 2025-07-05
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-14
• Last Update Submitted: 2025-09-14
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 197

Inclusion Criteria

• Overweight and obese infertile women attending the Reproductive Centre of Peking University People's Hospital for their first ART from January 2019 to December 2020

Exclusion Criteria

• Women were excluded from enrolment if they had concomitant endocrine abnormalities, chromosomal abnormalities affecting pregnancy outcome, history of previous ovarian surgery, or malformed uterus.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of participants with live birth	From Day 0 of the first embryo transfer cycle (cycle length: 28 days) through the entire pregnancy period until delivery, including both preterm and full-term births	Live birth rate in overweight and obese infertile patients undergoing their first embryo transfer cycle, including premature and full-term birth

Trial Locations

Locations (1)

Min Fu; 🇨🇳 Beijing, Beijing Municipality, China