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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

Tracking Information
First Submitted Date  ICMJE May 25, 2017
First Posted Date  ICMJE June 6, 2017
Last Update Posted Date January 9, 2020
Actual Study Start Date  ICMJE March 1, 2017
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2017)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Myo-Inositol- Based Co-treatment in Women With PCOS Undergoing Assisted Reproductive Technology
Official Title  ICMJE Effect of Myo-Inositol- Based Co-treatment on Oocyte Quality in Women With Polycystic Ovarian Syndrome Undergoing Assisted Reproductive Technology
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sterility
  • Infertility
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: Myo-inositol
  • No Intervention: No intervention
    Standard care: 400 ug of Folic acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 2, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 18 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Johnny Awwad, MD 009611350000 ext 5606 jawwad@aub.edu.lb
Contact: Layal Hamdar, MS 009611350000 ext 5606 lh72@aub.edu.lb
Listed Location Countries  ICMJE Lebanon
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03177122
Other Study ID Numbers  ICMJE AmericanUBMCMYO
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johnny Awwad, American University of Beirut Medical Center
Study Sponsor  ICMJE American University of Beirut Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Johnny Awwad, MD American University of Beirut Medical Center
PRS Account American University of Beirut Medical Center
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP