Myo-Inositol- Based Co-treatment in Women With PCOS Undergoing Assisted Reproductive Technology (NCT03177122) | Clinical Trial Compass
UnknownPhase 4
Myo-Inositol- Based Co-treatment in Women With PCOS Undergoing Assisted Reproductive Technology
Lebanon100 participantsStarted 2017-03-01
Plain-language 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.
Who can participate
Age range
18 Years – 18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Oocyte yield
Timeframe: 1 day from ovum pick up
2
Maturation rate
Timeframe: 1 day from ovum pick up
3
Fertilization rate
Timeframe: 16-18 hours post insemination
Trial details
NCT IDNCT03177122
SponsorAmerican University of Beirut Medical Center