CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 379 enrolled
Drug / intervention
Orlistat +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02432209
NCT02432209Phase 3Completed
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Improving Reproductive Fitness Through Pretreatment With Lifestyle Modification in Obese Women With Unexplained Infertility

Yale University·interventional·Posted May 4, 2015·Updated Feb 3, 2022

In Brief

A Phase 3 clinical trial evaluating Caloric Restriction, Orlistat, and 1 other intervention for Infertility, Female. Completed, enrolled 379 participants across 10 sites.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfertility, Female
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Penn State University, Augusta University, University of California, San Francisco, University of North Carolina, University of Oklahoma, University of Pennsylvania

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 4, 2015
Enrollment StartAug 1, 2015
Primary CompletionNov 30, 2019
Study CompletionMay 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 11.2 years ago

Interventions

Caloric Restrictionother

Subjects on Active comparator will have Caloric Restriction to a 1200-1500 kcal/day diet through use of Nutrisystem Meal Plan.

Orlistatdrug

Subjects on Active comparator will use an over-the-counter weight loss medication, Orlistat, a gastric lipase inhibitor that limits gut fat absorption.

Moderate physical activityother

All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.