Status:
COMPLETED
Vaginal Progesterone Supplementation in Women With PCOS Undergoing Ovulation Induction With Letrozole
Lead Sponsor:
Eastern Virginia Medical School
Collaborating Sponsors:
Watson Pharmaceuticals
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
20-40 years
Phase:
PHASE2
PHASE3
Brief Summary
Aromatase inhibitors such as letrozole are hypothesized to maintain normal hypothalamic/ pituitary feedback mechanisms and in the case of OI (ovulation induction) in women with PCOS, may act to increa...
Detailed Description
Approval of the study was obtained from the local IRB. Prospective volunteers had had an infertility workup including blood hormone levels (FSH, LH, E2, Progesterone, Prolactin, and Thyroid), partner'...
Eligibility Criteria
Inclusion
- Women who have anovulatory or oligoovulatory infertility who are undergoing ovulation induction for infertility with TI or IUI , with or without regular cycles defined as cycle length \> 35 days, \< 26 days or amenorrhea (no cycles in the past six months), and who meet 2 out of 3 of the Rotterdam Criteria (1. Chronic anovulation or irregular cycles, 2. Clinical or biochemical hyperandrogenism, 3. Polycystic appearing ovaries on ultrasound.)
- Day 3 FSH(Follicle stimulating hormone)\< 10 (obtained within 2 years prior to screening
- Documented infertility for at least 1 year or documented anovulation
- Willing to participate in up to 3 cycles of OI with letrozole and IUI or TI
- Partner's or donor's SA\> 5 million motile sperm within 2 years of screening
- Patients may have received clomiphene citrate or letrozole treatment in the past.
Exclusion
- Untreated thyroid or prolactin abnormalities
- Pregnancy in the last 3 months
- BMI\< 18 or \>40kg/m2
- Abnormal uterine bleeding of undetermined origin
- Contraindications to pregnancy
- Progesterone sensitivity
- Uterine anomalies seen on ultrasound (performed within 6 months prior to screening) that can affect pregnancy chances such as submucosal uterine fibroids or polyps
- Three or more previous consecutive pregnancy losses
- Blocked fallopian tubes X2 (documented by HSG, laparoscopy, or hydrosonogram completed within past 3 years)
- More than 3 failed monitored letrozole cycles prior to enrolling
Key Trial Info
Start Date :
July 6 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2017
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03440359
Start Date
July 6 2012
End Date
December 30 2017
Last Update
February 26 2018
Active Locations (1)
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1
Laurel A. Stadtmauer, MD, PhD
Norfolk, Virginia, United States, 23507