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NCT02432209 · ClinicalTrials.gov registry record · Phase 3
Improving Reproductive Fitness Through Pretreatment With Lifestyle Modification in Obese Women With Unexplained Infertility
A Phase 3 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 3
- Development phase
- 379
- Enrollment target
NCT02432209: Completed Phase 3 study, sponsored by Yale University.
NCT02432209 is a Phase 3 study that has completed, run by Yale University. The registered enrollment target is 379 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02432209, a Phase 3 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 379 participants
- Enrollment target
Study 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).
Primary Outcome
Defined as a live birth of an infant born at ≥ 37 weeks, with a birth weight between 2500 and 4000g and without a major congenital anomaly
Interventions
- DRUG Orlistat
- OTHER Caloric Restriction
- OTHER Moderate physical activity
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 379 participants |
| Start Date | 2015-08 |
| Est. Completion | 2020-05 |
| Phase | Phase 3 |
What the finished NCT02432209 record still lists
NCT02432209 is an interventional study that assigns participants to a tested intervention. The registered 379 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 3 interventions - of which Orlistat is the first listed.
NCT02432209 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02432209 about?
NCT02432209 is a clinical study titled "Improving Reproductive Fitness Through Pretreatment With Lifestyle Modification in Obese Women With Unexplained Infertility". 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 obesit...
What is the current status of trial NCT02432209?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 379 participants. The study started on 2015-08. Estimated completion is 2020-05.
What interventions are being tested in trial NCT02432209?
The interventions under investigation include: Orlistat (DRUG), Caloric Restriction (OTHER), Moderate physical activity (OTHER).
Who is sponsoring clinical trial NCT02432209?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02432209's enrollment target sits among peer trials
379 987th of 2000 higher than 1,013 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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