Overview

Metformine and CC Compared With Placebo and CC for Induction Ovulation in PCOS Patients With Insulin Resistant

Status:
Enrolling by invitation

Trial end date:
2022-08-01

Target enrollment:
0

Participant gender:
Female

Summary

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Semnan University of Medical Sciences

Treatments:

Citric Acid
Clomiphene
Enclomiphene
Metformin
Progestins
Zuclomiphene

Criteria

Inclusion Criteria:

- Insulin resistant ( HOMA-IR≥2.3) PCOS women between 20-36 years of age, with period of
infertility more than 1 year and normal serum prolactin ,normal TSH after treatment ,
normal hystero salpingography and had no other infertility factor.

The diagnosis of PCOS according to the Rotterdam Criteria.

Exclusion Criteria:

- Diabetic women

- Any medication that could influence carbohydrate metabolism or pituitary-gonadal
function at least 2 months before the study

- Hypertension or abnormal renal or liver function tests

- Ovarian drilling.