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

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ClinicalTrials.gov Identifier: NCT03177122
Recruitment Status : Recruiting
First Posted : June 6, 2017
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Johnny Awwad, American University of Beirut Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sterility Infertility Drug: Myo-inositol Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Inositol

Arms and Interventions
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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 Name: Celine
No Intervention: No intervention
Standard care: 400 ug of Folic acid


Outcome Measures
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Primary Outcome Measures :
  1. Oocyte yield [ Time Frame: 1 day from ovum pick up ]
  2. Maturation rate [ Time Frame: 1 day from ovum pick up ]
  3. Fertilization rate [ Time Frame: 16-18 hours post insemination ]

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

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

Locations
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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
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Principal Investigator: Johnny Awwad, MD American University of Beirut Medical Center
More Information
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Responsible Party: Johnny Awwad, Professor of Obstetrics and Gynecology, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT03177122    
Other Study ID Numbers: AmericanUBMCMYO
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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