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 14, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sterility Infertility | Drug: Myo-inositol | Phase 4 |
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 |

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
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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
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- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 18 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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.

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
Contact: Johnny Awwad, MD | 009611350000 ext 5606 | jawwad@aub.edu.lb | |
Contact: Layal Hamdar, MS | 009611350000 ext 5606 | lh72@aub.edu.lb |
Lebanon | |
American University of Beirut Medical Center | Recruiting |
Beirut, Lebanon | |
Contact: Johnny Awwad, MD 00961 1 350000 ext 5606 jawwad@aub.edu.lb |
Principal Investigator: | Johnny Awwad, MD | American University of Beirut Medical Center |
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 14, 2021 |
Last Verified: | January 2021 |
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 |
Polycystic Ovary Syndrome Myo-Inositol Assisted Reproductive Technology oocyte performance pregnancy |
Infertility Inositol Vitamin B Complex Vitamins |
Micronutrients Nutrients Growth Substances Physiological Effects of Drugs |