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Completed

NCT Number: NCT07174817

Weight Loss on IVF Outcomes in Overweight and Obese Infertile Women

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

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Key information

Age range

20 year–36 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Min Fu

Beijing, Beijing Municipality, 10000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Weight Loss

Behavioral

The weight loss intervention group underwent dietary and exercise programs for three months prior to initiating IVF treatment. These interventions included consuming foods with a low glycemic index (GI), achieving a daily net energy expenditure of 500-750 kcal, and engaging in moderate-intensity exercise 3-5 times per week. After the three-month period, weight maintenance was managed according to each patient's preferences.

Primary outcomes

  1. Rate of participants with live birth

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

Weight Loss on IVF Outcomes in Overweight and Obese Infertile Women: a Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 16, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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