Clinical trialNCT02432209CompletedPhase 3Interventional

Improving Reproductive Fitness Through Pretreatment With Lifestyle Modification in Obese Women With Unexplained Infertility

SponsorYale UniversityEnrollment379Infertility, Female

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

A two-arm, multicenter, prospective, randomized clinical trial of a lifestyle modification program with tracked increased physical activity and weight loss (intensive) compared to recommendations to tracking of increased physical activity alone with weight maintenance (standard) in women with obesity and unexplained infertility. This 16 week period of lifestyle modification will be followed by an open label empiric infertility treatment regimen consisting of three cycles of ovarian stimulation with oral medication (clomiphene citrate (CC)), triggering of ovulation with human chorionic gonadotropin (hCG) and intrauterine insemination (IUI).

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Anne Steiner, MD MPH
Univeristy of North Carolina
Study Director
clinicaltrials.gov ↗
Christos Coutifaris, MD PhD
University of Pennsylvania
Study Director
clinicaltrials.gov ↗
Esther Eisenberg, MD MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Director
clinicaltrials.gov ↗
Heping Zhang, PhD
Yale University
Study Director
clinicaltrials.gov ↗
Karl Hansen, MD PhD
University of Oklahoma
Study Director
clinicaltrials.gov ↗
Marcelle Cedars, MD
University of California, San Francisco
Study Director
clinicaltrials.gov ↗
Michael Diamond, MD
Augusta University
Study Director
clinicaltrials.gov ↗
Nanette Santoro, MD
University of Colorado, Denver
Study Chair
clinicaltrials.gov ↗
Richard Legro, MD
Penn State University
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

10 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of California San Francisco
San Francisco, California, United States
Augusta University
Augusta, Georgia, United States
Wayne State University
Southfield, Michigan, United States
University of Rochester
Rochester, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Atrium Health Carolinas Healthcare System
Charlotte, North Carolina, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Pennsylvania State University
Hershey, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Utah
Salt Lake City, Utah, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Orlistat

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Aug 2015
Primary completion: 30 Nov 2019
Completion: 31 May 2020
Last update posted: 3 Feb 2022
Registered enrollment: 379
Registry id: NCT02432209

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.