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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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2 August 2023 |
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Main ID: |
NCT03177122 |
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Date of registration:
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25/05/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Myo-Inositol- Based Co-treatment in Women With PCOS Undergoing Assisted Reproductive Technology
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Scientific title:
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Effect of Myo-Inositol- Based Co-treatment on Oocyte Quality in Women With Polycystic Ovarian Syndrome Undergoing Assisted Reproductive Technology |
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Date of first enrolment:
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March 1, 2017 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03177122 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Lebanon
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Contacts
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Name:
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Johnny Awwad, MD |
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Address:
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Telephone:
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00961 1 350000 |
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Email:
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jawwad@aub.edu.lb |
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Affiliation:
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Name:
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Johnny Awwad, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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American University of Beirut Medical Center |
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Name:
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Johnny Awwad, MD |
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Address:
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Telephone:
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009611350000 |
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Email:
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jawwad@aub.edu.lb |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
18 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Infertility
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Sterility
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Intervention(s)
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Drug: Myo-inositol
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Primary Outcome(s)
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Maturation rate
[Time Frame: 1 day from ovum pick up]
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Oocyte yield
[Time Frame: 1 day from ovum pick up]
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Fertilization rate
[Time Frame: 16-18 hours post insemination]
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Secondary Outcome(s)
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Obstetrical outcome (admission to neonatal intensive care)
[Time Frame: From 24 to 36 weeks gestation]
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Miscarriage rate
[Time Frame: 7 weeks post LMP]
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Number of gonadotropin ampules
[Time Frame: 1 day from oocyte maturation trigger]
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Embryo quality
[Time Frame: 3 to 5 days from ovum pick up]
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Obstetrical outcome (gestational diabetes)
[Time Frame: From 24 to 36 weeks gestation]
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Blood profile (fasting sugar and insulin levels, Testosterone, Sex Hormone-Binding protein, DHEAs, and Androstenedione)
[Time Frame: Prior to and 6 weeks post enrollment]
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Number of stimulation days
[Time Frame: 1 day from oocyte maturation trigger]
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Ongoing pregnancy
[Time Frame: 20 weeks post LMP]
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Obstetrical outcome (low birth weight)
[Time Frame: From 24 to 36 weeks gestation]
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Live birth rate
[Time Frame: 24 to 42 weeks gestation]
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Obstetrical outcome (preeclampsia)
[Time Frame: From 24 to 36 weeks gestation]
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Obstetrical outcome (preterm birth)
[Time Frame: From 24 to 36 weeks gestation]
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Secondary ID(s)
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AmericanUBMCMYO
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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