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

This study is currently recruiting participants.
Verified June 2017 by Johnny Awwad, American University of Beirut Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT03177122
First Posted: June 6, 2017
Last Update Posted: June 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Johnny Awwad, American University of Beirut Medical Center
  Purpose
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.

Condition Intervention Phase
Sterility Infertility Drug: Myo-inositol Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Myo-Inositol- Based Co-treatment on Oocyte Quality in Women With Polycystic Ovarian Syndrome Undergoing Assisted Reproductive Technology

Resource links provided by NLM:


Further study details as provided by Johnny Awwad, American University of Beirut Medical Center:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Blood profile (fasting sugar and insulin levels, Testosterone, Sex Hormone-Binding protein, DHEAs, and Androstenedione) [ Time Frame: Prior to and 6 weeks post enrollment ]
  • Number of gonadotropin ampules [ Time Frame: 1 day from oocyte maturation trigger ]
  • Obstetrical outcome (preterm birth) [ Time Frame: From 24 to 36 weeks gestation ]
  • Obstetrical outcome (low birth weight) [ Time Frame: From 24 to 36 weeks gestation ]
  • Obstetrical outcome (gestational diabetes) [ Time Frame: From 24 to 36 weeks gestation ]
  • Obstetrical outcome (preeclampsia) [ Time Frame: From 24 to 36 weeks gestation ]
  • Obstetrical outcome (admission to neonatal intensive care) [ Time Frame: From 24 to 36 weeks gestation ]
  • Number of stimulation days [ Time Frame: 1 day from oocyte maturation trigger ]
  • Embryo quality [ Time Frame: 3 to 5 days from ovum pick up ]
  • Miscarriage rate [ Time Frame: 7 weeks post LMP ]
  • Ongoing pregnancy [ Time Frame: 20 weeks post LMP ]
  • Live birth rate [ Time Frame: 24 to 42 weeks gestation ]

Estimated Enrollment: 100
Actual Study Start Date: March 1, 2017
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Celine
No Intervention: No intervention
Standard care: 400 ug of Folic acid

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 18 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177122


Contacts
Contact: Johnny Awwad, MD 009611350000 ext 5606 jawwad@aub.edu.lb
Contact: Layal Hamdar, MS 009611350000 ext 5606 lh72@aub.edu.lb

Locations
Lebanon
American University of Beirut Medical Center Recruiting
Beirut, Lebanon
Contact: Johnny Awwad, MD    00961 1 350000 ext 5606    jawwad@aub.edu.lb   
Sponsors and Collaborators
American University of Beirut Medical Center
Investigators
Principal Investigator: Johnny Awwad, MD American University of Beirut Medical Center
  More Information

Responsible Party: Johnny Awwad, Professor of Obstetrics and Gynecology, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT03177122     History of Changes
Other Study ID Numbers: AmericanUBMCMYO
First Submitted: May 25, 2017
First Posted: June 6, 2017
Last Update Posted: June 6, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Johnny Awwad, American University of Beirut Medical Center:
Polycystic Ovary Syndrome
Myo-Inositol
Assisted Reproductive Technology
oocyte performance
pregnancy

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Folic Acid
Inositol
Hematinics
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs