Myo-Inositol- Based Co-treatment in Women With PCOS Undergoing Assisted Reproductive Technology

Last updated: July 19, 2023
Sponsor: American University of Beirut Medical Center
Overall Status: Active - Recruiting

Phase

4

Condition

Infertility

Sterilization

Treatment

Myo-inositol

Clinical Study ID

NCT03177122
AmericanUBMCMYO
  • Ages 18-18
  • Female
  • Accepts Healthy Volunteers

Study Summary

This is a prospective comparative randomized controlled study investigating the effect of Myo-Inositol-based co-treatment on oocyte quality measures in women with PCOS.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18-40 years at the time of enrollment.
  • Women diagnosed with PCOS according to the Rotterdam criteria indicated byoligoamenorrhea (six or fewer menstrual cycles during a period of 1 year),hyperandrogenism (hirsutism, acne, or alopecia) or hyperandrogenemia (elevated levelsof total or free T) and typical features of ovaries on ultrasound scan.
  • Planned IVF/ICSI treatment.
  • Normal uterine cavity (as assessed by hysteroscopy or HSG).
  • Normal hormonal investigation: TSH and PRL.

Exclusion

Exclusion Criteria:

  • Azoospermia.
  • Other medical conditions causing ovulatory disorders, such as hyperprolactinemia,hypothyroidism, or adrenal hyperplasia.
  • Hypersensitivity to Myo-Inositol or its derivatives.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Myo-inositol
Phase: 4
Study Start date:
March 01, 2017
Estimated Completion Date:
December 31, 2023

Study Description

Polycystic Ovary Syndrome is the most common cause of chronic anovulation in women. Women with PCOS undergoing IVF are at an increased risk for developing both multiple gestation and ovarian hyperstimulation syndrome (OHSS). Since insulin resistance and hyperinsulinemia have been implicated in the pathophysiology of the disorder, the administration of metformin before or during an IVF cycle has been practiced for years in an attempt to improve follicular parameters necessary for reproductive success. Recently, a growing body of evidence has implicated alternative insulin sensitizing drugs, namely Myo-Inositol, in improving various manifestations of the disorder in this women population. Little has been done to evaluate the effect of Myo-Inositol co-treatment on the reproductive performance of PCOS women undergoing Assisted Reproductive Technologies (ART). In this prospective comparative randomized controlled study, women will be randomized into two groups: Women in the control group will receive folic acid daily. Women in the study group will receive Myo-Inositol, in combination with alpha- lipoic acid and cysteine, per day plus folic acid supplemented daily along with ovarian stimulation.

Connect with a study center

  • American University of Beirut Medical Center

    Beirut,
    Lebanon

    Active - Recruiting

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