Weight Loss on IVF Outcomes in Overweight and Obese Infertile Women

NCT ID: NCT07174817

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 197 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2020-12-31

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.

Conditions

Infertility; Weight Loss; Obesity; IVF

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

weight loss intervention

The weight loss intervention group received dietary and exercise interventions for 3 months prior to the start of IVF, including: intake of low glycemic index (GI) foods; a daily net energy expenditure of 500-750 Kcal; adherence to a weekly schedule of moderate-intensity exercise 3-5 times. After 3 months, weight maintenance management continued in accordance with the patients' preferences.

Group Type: EXPERIMENTAL

weight loss

Intervention Type: 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.

control

The control group, with standard clinical care, managed their weight independently before undergoing IVF.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

weight loss

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 36 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Fu Min

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Min Fu

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

2018PHB114-01

Identifier Type: -

Identifier Source: org_study_id