Clinical trial NCT03177122: Myo-Inositol- Based Co-treatment in Women With PCOS Undergoing Assisted Reproductive Technology
Official title: Effect of Myo-Inositol- Based Co-treatment on Oocyte Quality in Women With Polycystic Ovarian Syndrome Undergoing Assisted Reproductive Technology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Sterility
Infertility
Keywords: Polycystic Ovary Syndrome
Myo-Inositol
Assisted Reproductive Technology
oocyte performance
pregnancy
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2017-06-06
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 18
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Oocyte yield
timeFrame: 1 day from ovum pick up
measure: Maturation rate
timeFrame: 1 day from ovum pick up
measure: Fertilization rate
timeFrame: 16-18 hours post insemination
Secondary outcomes:
measure: Blood profile (fasting sugar and insulin levels, Testosterone, Sex Hormone-Binding protein, DHEAs, and Androstenedione)
timeFrame: Prior to and 6 weeks post enrollment
measure: Number of gonadotropin ampules
timeFrame: 1 day from oocyte maturation trigger
measure: Obstetrical outcome (preterm birth)
timeFrame: From 24 to 36 weeks gestation
measure: Obstetrical outcome (low birth weight)
timeFrame: From 24 to 36 weeks gestation
measure: Obstetrical outcome (gestational diabetes)
timeFrame: From 24 to 36 weeks gestation
measure: Obstetrical outcome (preeclampsia)
timeFrame: From 24 to 36 weeks gestation
measure: Obstetrical outcome (admission to neonatal intensive care)
timeFrame: From 24 to 36 weeks gestation
measure: Number of stimulation days
timeFrame: 1 day from oocyte maturation trigger
measure: Embryo quality
timeFrame: 3 to 5 days from ovum pick up
measure: Miscarriage rate
timeFrame: 7 weeks post LMP
measure: Ongoing pregnancy
timeFrame: 20 weeks post LMP
measure: Live birth rate
timeFrame: 24 to 42 weeks gestation
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
Study officials:
affiliation: American University of Beirut Medical Center
name: Johnny Awwad, MD
role: PRINCIPAL_INVESTIGATOR
References: