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NCT00719186 · ClinicalTrials.gov registry record · Phase 3
Pregnancy in Polycystic Ovary Syndrome II
A Phase 3 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 3
- Development phase
- 750
- Enrollment target
NCT00719186 is a Phase 3 study that has completed, run by Yale University. The registered enrollment target is 750 participants.
The verdict
NCT00719186, a Phase 3 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 750 participants
- Enrollment target
Study Summary
The primary research hypothesis is that ovulation induction with an aromatase inhibitor (letrozole) is more likely to result in live birth than ovulation induction with a selective estrogen receptor modulator (clomiphene citrate) in infertile women with PCOS. A safety hypothesis will also be incorporated into the primary research hypothesis in which we hypothesize both treatments are equally safe for mother and child. Secondary research hypotheses include: 1. Treatment with letrozole is more likely to result in singleton pregnancy compared to treatment with clomiphene citrate. Singleton pregnancy is defined as presence of a single intrauterine gestational sac with a single fetal pole and observable heart motion. 2. Treatment with letrozole will less likely result in a first trimester intrauterine fetal demise than treatment with clomiphene citrate. A first trimester IUFD is defined as a pregnancy that ends before 13 weeks gestation. 3. Treatment with letrozole is more likely to result in ovulation (increased ovulation rate) compared to treatment with clomiphene citrate. Ovulation is defined as a midluteal progesterone level ≥ 3 ng/mL. 4. The shortest time to pregnancy will be with letrozole. 5. Age, body mass index, SHBG, testosterone, LH, Anti-Mullerian Hormone (AMH), and degree of hirsutism and acne will be significant predictors of ovulation and conception regardless of treatment. 6. Improvement in SHBG, testosterone, AMH, and LH levels will be significant predictors of ovulation and conception regardless of treatment. 7. DNA polymorphisms in estrogen action genes will predict response to study drug. 8. Quality of Life will be better on letrozole than clomiphene. 9. Letrozole will be more cost effective at achieving singleton pregnancies than clomiphene.
Interventions
- DRUG Letrozole
- DRUG Clomiphene citrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 750 participants |
| Start Date | 2009-02 |
| Est. Completion | 2013-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00719186
The ClinicalTrials.gov registry entry for NCT00719186 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 750 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 2 interventions - of which Letrozole is the first listed.
NCT00719186 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00719186 about?
NCT00719186 is a clinical study titled "Pregnancy in Polycystic Ovary Syndrome II". The primary research hypothesis is that ovulation induction with an aromatase inhibitor (letrozole) is more likely to result in live birth than ovulation induction with a selective estrogen receptor modulator (clomiphene citrate) in infertile women with PCOS. A safety hypothesis will also be incorpo...
What is the current status of trial NCT00719186?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 750 participants. The study started on 2009-02. Estimated completion is 2013-05.
What interventions are being tested in trial NCT00719186?
The interventions under investigation include: Letrozole (DRUG), Clomiphene citrate (DRUG).
Who is sponsoring clinical trial NCT00719186?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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