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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 is a Phase 3 study that has completed, run by Yale University. The registered enrollment target is 379 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02432209
The ClinicalTrials.gov registry entry for NCT02432209 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 379 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Orlistat is the first listed.
NCT02432209 reports 0 study locations.
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.
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