Myo-inositol Versus Clomiphene Citrate in PCOS

Ghent University Hospital (UZ)

Status and phase: Terminated; Phase 4

Conditions: Ovulation Induction; Inositol; Polycystic Ovary Syndrome; Clomiphene

Treatments: Drug: Myo-inositol; Drug: Clomiphene Citrate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04306692

2018-004604-20

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Inositol group

Experimental group

Description:

Myo-inositol 4000 mg Dosing: 2 x 1 bag per day, per os (subjects can take myo-inositol during the meal but it is not obliged) during 3 consecutive treatment cycles.

Treatment:

Drug: Myo-inositol

Clomiphene citrate group

Active Comparator group

Description:

Each tablet contains 50 mg of clomiphene citrate Dosing: 1 tablet per day, per os, from cycle day 3 until 7 (extremes included), stepping up until a maximum dose of 3 tablets per day for 5 consecutive days during 3 consecutive treatment cycles.

Treatment:

Drug: Clomiphene Citrate