Effect of Myo-Inositol- Based Co-treatment on Oocyte Quality in Women With Polycystic Ovarian Syndrome Undergoing Assisted Reproductive Technology
Overview
- Phase
- Phase 4
- Intervention
- Myo-inositol
- Conditions
- Sterility
- Sponsor
- American University of Beirut Medical Center
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Oocyte yield
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Johnny Awwad
Professor of Obstetrics and Gynecology
American University of Beirut Medical Center
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.
Arms & Interventions
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
Intervention: Myo-inositol
Outcomes
Primary Outcomes
Oocyte yield
Time Frame: 1 day from ovum pick up
Maturation rate
Time Frame: 1 day from ovum pick up
Fertilization rate
Time Frame: 16-18 hours post insemination
Secondary Outcomes
- Embryo quality(3 to 5 days from ovum pick up)
- Ongoing pregnancy(20 weeks post LMP)
- Obstetrical outcome (preterm birth)(From 24 to 36 weeks gestation)
- Obstetrical outcome (admission to neonatal intensive care)(From 24 to 36 weeks gestation)
- Number of stimulation days(1 day from oocyte maturation trigger)
- Miscarriage rate(7 weeks post LMP)
- Live birth rate(24 to 42 weeks gestation)
- Obstetrical outcome (gestational diabetes)(From 24 to 36 weeks gestation)
- Obstetrical outcome (preeclampsia)(From 24 to 36 weeks gestation)
- Blood profile (fasting sugar and insulin levels, Testosterone, Sex Hormone-Binding protein, DHEAs, and Androstenedione)(Prior to and 6 weeks post enrollment)
- Number of gonadotropin ampules(1 day from oocyte maturation trigger)
- Obstetrical outcome (low birth weight)(From 24 to 36 weeks gestation)