Myo-inositol Versus Clomiphene Citrate in PCOS

• Status: Recruiting
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

Specific aim: To compare inositol and the golden standard first line treatment of ovulation induction, namely clomiphene citrate.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Ghent
• Collaborators: AZ Jan Palfijn Gent; Gedeon Richter Plc.; Our Lady of Lourdes Hospital Waregem; University Hospital, Antwerp
• Treatments: Citric Acid; Clomiphene; Enclomiphene; Inositol; Sodium Citrate; Zuclomiphene

Criteria

Inclusion Criteria:

• 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 Criteria:

• Tubal factors

• Uterine factors

• Endometriosis AFS score 3 or 4

• Moderate to severe male factor (as defined by each local center)

• BMI > 35