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

Effect of Myo-Inositol- Based Co-treatment on Oocyte Quality in Women With Polycystic Ovarian Syndrome Undergoing Assisted Reproductive Technology

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.

Study Overview

• Status: Recruiting
• Conditions: Infertility; Sterility
• Intervention / Treatment: Drug: Myo-inositol

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Johnny Awwad, MD; Phone Number: 5606 009611350000; Email: jawwad@aub.edu.lb
• Study Contact Backup: Name: Layal Hamdar, MS; Phone Number: 5606 009611350000; Email: lh72@aub.edu.lb

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Recruiting
    • American University of Beirut Medical Center
    • Contact: Johnny Awwad, MD; Phone Number: 5606 00961 1 350000; Email: jawwad@aub.edu.lb

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 18 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: 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.; Other Names: Celine
No Intervention: No intervention; Standard care: 400 ug of Folic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Oocyte yield	1 day from ovum pick up
Maturation rate	1 day from ovum pick up
Fertilization rate	16-18 hours post insemination

Secondary Outcome Measures

Outcome Measure	Time Frame
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 (preterm birth)	From 24 to 36 weeks gestation
Obstetrical outcome (low birth weight)	From 24 to 36 weeks gestation
Obstetrical outcome (gestational diabetes)	From 24 to 36 weeks gestation
Obstetrical outcome (preeclampsia)	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
Embryo quality	3 to 5 days from ovum pick up
Miscarriage rate	7 weeks post LMP
Ongoing pregnancy	20 weeks post LMP
Live birth rate	24 to 42 weeks gestation

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center
• Investigators: Principal Investigator: Johnny Awwad, MD, American University of Beirut Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: May 25, 2017
• First Submitted That Met QC Criteria: June 2, 2017
• First Posted (Actual): June 6, 2017

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Assisted Reproductive Technology; Polycystic Ovary Syndrome; pregnancy; Myo-Inositol; oocyte performance
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Inositol
• Other Study ID Numbers: AmericanUBMCMYO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No