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

NCT ID: NCT03177122

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2023-12-31

Brief 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.

Detailed 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.

Conditions

Sterility; Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Myo-Inositol

1g Myo-inositol per day, in combination with alpha- lipoic acid and cysteine, (Celine Tablets; Surveal Pharmaceuticals; Belgium) + 400 ug of Folic acid

Group Type: EXPERIMENTAL

Myo-inositol

Intervention Type: DRUG

Patients belonging to this group will receive 1 gram of Myo-Inositol, in combination with alpha- lipoic acid and cysteine, (Celine Tablets; Surveal Pharmaceuticals; Belgium) starting 6 weeks prior to stimulation and extending until final oocyte maturation, combined with 400 µg of folic acid supplemented daily.

No intervention

Standard care: 400 ug of Folic acid

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Myo-inositol

Patients belonging to this group will receive 1 gram of Myo-Inositol, in combination with alpha- lipoic acid and cysteine, (Celine Tablets; Surveal Pharmaceuticals; Belgium) starting 6 weeks prior to stimulation and extending until final oocyte maturation, combined with 400 µg of folic acid supplemented daily.

Intervention Type: DRUG

Other Intervention Names

Celine

Eligibility Criteria

Inclusion Criteria

• Age 18-40 years at the time of enrollment.
• Women diagnosed with PCOS according to the Rotterdam criteria indicated by oligoamenorrhea (six or fewer menstrual cycles during a period of 1 year), hyperandrogenism (hirsutism, acne, or alopecia) or hyperandrogenemia (elevated levels of 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 Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

American University of Beirut Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Johnny Awwad

Professor of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Johnny Awwad, MD

Role: PRINCIPAL_INVESTIGATOR

American University of Beirut Medical Center

Locations

American University of Beirut Medical Center

Beirut, , Lebanon

Site Status: RECRUITING

Countries

Lebanon

Central Contacts

Johnny Awwad, MD

Role: CONTACT

jawwad@aub.edu.lb

009611350000 ext. 5606

Layal Hamdar, MS

Role: CONTACT

lh72@aub.edu.lb

009611350000 ext. 5606

Facility Contacts

Johnny Awwad, MD

Role: primary

jawwad@aub.edu.lb

00961 1 350000 ext. 5606

References

Shukla R, Chadha M, Adya A, Yadav A, Singh N, Chauhan RS, Ahmad A, Tiwari RK. Ongoing Clinical Trials for Polycystic Ovarian Syndrome (PCOS) Afflicted Infertility in Women: A Narrative Review. Rev Recent Clin Trials. 2025;20(2):113-123. doi: 10.2174/0115748871325070241008101355.

Reference Type: DERIVED

PMID: 39421989 (View on PubMed)

Other Identifiers

AmericanUBMCMYO

Identifier Type: -

Identifier Source: org_study_id