Myo-inositol Versus Clomiphene Citrate in PCOS

NCT04306692 | Terminated Phase 4

• 1 other identifier: 2018-004604-20
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ovulation Induction; Polycystic Ovary Syndrome; Clomiphene; Inositol

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  At 7 - 8 gestational weeks

Secondary Outcomes (4)

• The number of potential adverse events

  During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)

• The occurrence of ovulation

  During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)

• The number of cancelled treatment cycles

  During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)

• The number of multiple pregnancies

  During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)

Study Arms (2)

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.

Drug: Myo-inositol

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.

Drug: Clomiphene Citrate

Interventions

Myo-inositol DRUG

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

Inositol group

Clomiphene Citrate DRUG

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.

Clomiphene citrate group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Tubal factors
• Uterine factors
• Endometriosis AFS score 3 or 4
• Moderate to severe male factor (as defined by each local center)
• BMI \> 35

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Gedeon Richter Plc.: collaborator
• University Hospital, Antwerp: collaborator
• AZ Jan Palfijn Gent: collaborator
• Our Lady of Lourdes Hospital Waregem: collaborator

Study Sites (1)

University Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Inositol; Clomiphene

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: March 13, 2020
• Study Start: July 2, 2020
• Primary Completion: April 20, 2021
• Study Completion: January 31, 2022
• Last Updated: December 21, 2022

Record last verified: 2022-12

Locations

BE (1)