Myo-inositol Versus Clomiphene Citrate in PCOS

Phase 4

Terminated

• Conditions: Ovulation Induction; Polycystic Ovary Syndrome; Clomiphene; Inositol
• Interventions: Drug: Myo-inositol; Drug: Clomiphene Citrate

• Registration Number: NCT04306692
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-12
• Study First Submitted QC: 2020-03-12
• Study First Posted: 2020-03-13
• Study Start: 2020-07-02
• Primary Completion: 2021-04-20
• Study Completion: 2022-01-31
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-16
• Last Update Posted: 2022-12-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inositol group	Myo-inositol	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.
Clomiphene citrate group	Clomiphene Citrate	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.

Primary Outcome Measures

Name	Time	Method
Rate of cumulative ongoing pregnancy (a pregnancy diagnosed by ultrasonic visualisation of one or more gestational sacs with fetal heart beat) after 3 treatment cycles with inositol versus clomiphene citrate for ovulation induction.	At 7 - 8 gestational weeks	Recently, a meta-analysis on the use of inositol in PCOS was published. This study showed that inositol leads to a more regular menstrual cycle and recovery of ovarian function. Less data are present on pregnancy rates. No RCT was found on the comparison between inositol and the golden standard first line treatment of ovulation induction, namely clomiphene citrate. Another advantage of inositol is that it doesn't have side effects compared to metformin and that there is no elevated risk on multiple pregnancies, which is the case with clomiphene citrate.

Secondary Outcome Measures

Name	Time	Method
The number of potential adverse events	During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)	The potential adverse events will be measured to determine whether the compliance for the patient is acceptable.
The occurrence of ovulation	During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)	The occurence of ovulation will be measured to determine whether the compliance for the patient is acceptable.
The number of cancelled treatment cycles	During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)	The number of cancelled treatment cycles will be measured to determine whether the compliance for the patient is acceptable.
The number of multiple pregnancies	During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)	The number of multiple pregnancies will be measured to determine whether the compliance for the patient is acceptable.

Trial Locations

Locations (1)

University Hospital; 🇧🇪 Ghent, Belgium