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

NCT02523898 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 388

Last updated 2024-04-25

No results posted yet for this study

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.

Conditions

  • Polycystic Ovary Syndrome
  • Hyperandrogenism

Interventions

DRUG

metformine

1500 mg metformine 8week plus 100 mg clomiphene for 5 days

DRUG

placebo

placebo 8 weeks plus 100 mg clomiphene for 5 days

DRUG

clomiphene citrate

100 mg clomiphene for 5 days starting from day 3 of their spontaneous menses or withdrawal bleeding induced by progestin administration

Sponsors & Collaborators

  • Semnan University of Medical Sciences

    lead OTHER

Principal Investigators

  • Human M Fatemi, MD · Director GCC-Operations | Nova IVI Fertility LLC .Royale Marina Office, B22-23 P.O. 60202.Abu Dhabi/UAE

  • Azam Azargoon, MD · Abnormal Uterine Bleeding Research Center, Semnan University of Medical Sciences, Semnan, Iran.

  • Majid Mirmohammadkhani, Phd · Social Determinants of Health Research Center, Semnan University of Medical Sciences, Semnan, Iran.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
36 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2022-04-30
Completion
2022-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02523898 on ClinicalTrials.gov