Myo-Inositol treatment for women with PCOS undergoing IVF
Effect of Myo-Inositol- Based Co-treatment on Oocyte Quality in Women With Polycystic Ovarian Syndrome Undergoing Assisted Reproductive Technology
This study is testing if adding Myo-Inositol to the treatment of women with PCOS who are going through IVF can improve the quality of their eggs compared to taking just folic acid.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 18 Years |
| Sex | Female |
| Sponsor | American University of Beirut Medical Center Academic / other |
| Locations | 1 site (Beirut) |
| Trial ID | NCT03177122 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of Myo-Inositol-based co-treatment on oocyte quality in women with Polycystic Ovary Syndrome (PCOS) who are undergoing Assisted Reproductive Technology (ART). Participants will be randomly assigned to receive either Myo-Inositol combined with alpha-lipoic acid and cysteine, or a control treatment of folic acid alone, during their IVF cycle. The aim is to assess whether this co-treatment can improve reproductive outcomes by enhancing oocyte performance. The study focuses on women aged 18-40 diagnosed with PCOS according to established criteria.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-40 with a diagnosis of PCOS who are planning to undergo IVF or ICSI treatment.
Not a fit: Patients with azoospermia or other medical conditions causing ovulatory disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve fertility outcomes for women with PCOS undergoing IVF.
How similar studies have performed: Previous studies have shown promising results with Myo-Inositol in improving reproductive parameters in women with PCOS, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beirut
- American University of Beirut Medical Center — Beirut, Lebanon (Recruiting)
Study contacts
- Principal investigator: Johnny Awwad, MD — American University of Beirut Medical Center
- Study coordinator: Johnny Awwad, MD
- Email: jawwad@aub.edu.lb
- Phone: 009611350000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.