Status:
TERMINATED
Myo-inositol Versus Clomiphene Citrate in PCOS
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
Gedeon Richter Plc.
University Hospital, Antwerp
Conditions:
Ovulation Induction
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-40 years
Phase:
PHASE4
Brief Summary
Specific aim: To compare inositol and the golden standard first line treatment of ovulation induction, namely clomiphene citrate.
Eligibility Criteria
Inclusion
- Rotterdam criteria for PCOS (cf. the recent ESHRE guidelines): at least 2 out of 3 criteria should be fulfilled: irregular cycle (shorter than 21 days or longer than 35 days); clinical (modified Ferriman-Gallwey score ≥ 6) or biochemical signs (elevated free testosterone) of hyperandrogenism (www.eshre.eu/Guidelines-and- Legal/Guidelines/Polycystic-Ovary-Syndrome.aspx); PCO ovaries on ultrasound (www.eshre.eu/Guidelines-and- Legal/Guidelines/Polycystic-Ovary-Syndrome.aspx): multiple small cysts (≥ 20 per ovary and/or an ovarian volume ≥ 10 ml, measured with a probe \>8 MHz) in both ovaries.
- A first treatment cycle, possibly combined with intra uterine insemination (IUI) and this for (one of) the following reasons: mild male factor (as defined by each local center) endometriosis AFS score 1 or 2
- Use of own or donor sperm.
Exclusion
- Tubal factors
- Uterine factors
- Endometriosis AFS score 3 or 4
- Moderate to severe male factor (as defined by each local center)
- BMI \> 35
Key Trial Info
Start Date :
July 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04306692
Start Date
July 2 2020
End Date
January 31 2022
Last Update
December 21 2022
Active Locations (1)
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1
University Hospital
Ghent, Belgium, 9000