Trial | NCT04306692  Report issue

Title

Myo-inositol Versus Clomiphene Citrate in PCOS
Myo-inositol Versus Clomiphene Citrate as First Line Treatment for Ovulation Induction in PCOS

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    12
Specific aim: To compare inositol and the golden standard first line treatment of ovulation induction, namely clomiphene citrate.
Study Started
Jul 02
2020
Primary Completion
Apr 20
2021
Study Completion
Jan 31
2022
Last Update
Dec 21
2022

Drug Myo-inositol

2 x 1 bag per day, per os (subjects can take myo-inositol during the meal but it is not obliged).

Drug Clomiphene Citrate

Each tablet contains 50 mg of clomiphene citrate which means 33,9 mg of clomiphene. Other constituents are sucrose, lactose monohydrate, corn starch, pregelatinized starch, yellow iron oxide (E172) and magnesium stearate (E470b). Dosing: 1 tablet per day from cycle day 3 until 7 (extremes included), stepping up until a maximum dose of 3 tablets per day for 5 consecutive days.

Inositol group Experimental

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 Active Comparator

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.

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
No Results Posted