Weight Loss on IVF Outcomes in Overweight and Obese Infertile Women

NCT07174817 | Completed

• 1 other identifier: 2018PHB114-01
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 1

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

Conditions

Infertility; Weight Loss; Obesity; IVF

Outcome Measures

Primary Outcomes (1)

• Rate of participants with live birth

  Live birth rate in overweight and obese infertile patients undergoing their first embryo transfer cycle, including premature and full-term 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

Study Arms (2)

weight loss intervention

EXPERIMENTAL

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.

Behavioral: weight loss

control

NO INTERVENTION

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

Interventions

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.

weight loss intervention

Eligibility Criteria

• Age: 20 Years - 36 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Min Fu

Beijing, Beijing Municipality, 10000, China

Location

MeSH Terms

Conditions

Infertility; Weight Loss; Obesity

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: September 16, 2025
• Study Start: January 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

CN (1)