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Is the Co-administration of Metformine and CC as Compared to Placebo and CC Superior to Induce Ovulation in PCOS Patients With a Confirmed insulin-resistant-a Double Blind Randomized Clinical Trial
Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility which affects 12-21% of the population.Several studies performed evaluate the possible benefit of metformin alone or in combination with clomiphene (CC)as first-line treatment for infertility in women with PCOS have reported conflicting results. These conflicting results may be due to the presence or absence of insulin resistance(IR).Metformin decreases IR .However there is not a single randomized clinical trial with metformin in IR PCOS patients. Therefore, the aim of current study is to compare CC with coadministration of metformin and with CC with coadministration of placebo in IR PCOS patients to induce ovulation.
Details
| Lead sponsor | Semnan University of Medical Sciences |
|---|---|
| Phase | Phase 2 |
| Status | TERMINATED |
| Enrolment | 388 |
| Start date | 2015-11 |
| Completion | 2022-04 |
Conditions
- Polycystic Ovary Syndrome
- Hyperandrogenism
Interventions
- metformine
- placebo
- clomiphene citrate
Primary outcomes
- ovulation rate — every other weeks up to 8 weeks
The progesterone levels will be measured every other week in order to document ovulation. A progesterone level \> 5 ng/ml (16 nmol per liter) will considered as confirmatory of ovulation during metformine administration .Ovarian follicular response will be monitored by transvaginal sonography every other day from day 10 of the cycle to the 16th day of the cycle.ovulation will be confrmed When at least one follicle reached ≥18 mm in diameter.