Myo-inositol Versus Clomiphene Citrate in PCOS

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04306692
• Other study ID #: 2018-004604-20
• Status: Terminated
• Phase: Phase 4
• Start date: July 2, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: December 2022
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: January 31, 2022
• Est. primary completion date: April 20, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Clomiphene
• Inositol
• Ovulation Induction
• Polycystic Ovary Syndrome

Intervention

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

Locations

Country	Name	City	State
Belgium	University Hospital	Ghent

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Ghent	AZ Jan Palfijn Gent, Gedeon Richter Plc., Our Lady of Lourdes Hospital Waregem, University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The number of potential adverse events	The potential adverse events will be measured to determine whether the compliance for the patient is acceptable.	During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)
Secondary	The occurrence of ovulation	The occurence of ovulation will be measured to determine whether the compliance for the patient is acceptable.	During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)
Secondary	The number of cancelled treatment cycles	The number of cancelled treatment cycles will be measured to determine whether the compliance for the patient is acceptable.	During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)
Secondary	The number of multiple pregnancies	The number of multiple pregnancies will be measured to determine whether the compliance for the patient is acceptable.	During 3 consecutive treatment cycles (each treatment cycle is up to 5 weeks)