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Weight Loss on IVF Outcomes in Overweight and Obese Infertile Women

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07174817
Enrollment
197
Registered
2025-09-16
Start date
2019-01-01
Completion date
2020-12-31
Last updated
2025-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, IVF, Obesity, Weight Loss

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.

Interventions

BEHAVIORALweight 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.

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 36 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Rate of participants with live birthFrom 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 birthsLive birth rate in overweight and obese infertile patients undergoing their first embryo transfer cycle, including premature and full-term birth

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026