Evaluation of the Mixture Myoinositol:D-chiro-inositol 3.6:1 in Women With Polycystic Ovary Syndrome

Phase 2

Completed

• Conditions: Polycystic Ovarian Syndrome; Infertility
• Interventions: Drug: D-chiro-inositol; Drug: Myoinositol

• Registration Number: NCT03201601
• Lead Sponsor: Biosearch S.A.

Brief Summary

The aim of the present study is to evaluate the effect of increasing the proportion of D-chiro-inositol (DCI) in a combination with myo-inositol (MYO) in improving fertility in women with polycystic ovarian syndrome (PCOS). Sixty women diagnosed with PCOS will randomly take twice a day for 12 weeks a capsule containing 550 mg of myo-inositol and 150 mg of D-chiro-inositol or capsules containing 550 mg of myo-inositol and 13.8 mg of D-chiro-inositol.

Detailed Description

Polycystic ovarian syndrome (PCOS) is the most prevalent endocrinopathy in women of childbearing age. It affects 4-8% of the population and of them, approximately 74% present anovulatory cycles and, therefore, fertility problems.

Both myo-inositol and D-chiro-inositol are 2 natural substances that have been shown to improve ovarian function and metabolism in women with polycystic ovarian syndrome.

The aim of the present study is to compare the effect of 2 ratios of myo-inositol /D-chiro-inositol on parameters related to the fertility of women with PCOS.

It is a multicenter, controlled, randomized, double-blind, parallel-group, 12-week clinical trial which will be conducted in 13 public and private hospitals from Spain.

Study Timeline

• Study Start: 2016-02
• Status Verified: 2016-10
• Primary Completion: 2017-05
• Study Completion: 2017-05-05
• Study First Submitted: 2017-06-27
• Study First Submitted QC: 2017-06-27
• Study First Posted: 2017-06-28
• Last Update Submitted: 2019-01-09
• Last Update Posted: 2019-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Being diagnosed with PCOS according to Rotterdam criteria.
• Being in in vitro fertilization treatment.
• Body mass index less than 30 kg/m2.
• Accept freely to participate in the study and sign the informed consent document.

Exclusion Criteria

• Contraindication to perform techniques of assisted reproduction or stimulation of ovulation.
• Advanced state of endometriosis (III or IV).
• Classified as poor responder in fertility treatment.
• Premature ovarian failure.
• Severe male factor (cryptozoospermia).
• Few expectations of compliance and/or collaboration.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
550 mg of MYO and 150 mg of DCI	Myoinositol	Volunteers will take twice at day for 12 weeks a capsule containing 550 mg of myo-inositol and 150 mg of D-chiro-inositol.
550 mg of MYO and 13.8 mg of DCI	Myoinositol	Volunteers will take twice at day for 12 weeks a capsule containing 550 mg of myo-inositol and 13.8 mg of D-chiro-inositol.
550 mg of MYO and 150 mg of DCI	D-chiro-inositol	Volunteers will take twice at day for 12 weeks a capsule containing 550 mg of myo-inositol and 150 mg of D-chiro-inositol.
550 mg of MYO and 13.8 mg of DCI	D-chiro-inositol	Volunteers will take twice at day for 12 weeks a capsule containing 550 mg of myo-inositol and 13.8 mg of D-chiro-inositol.

Primary Outcome Measures

Name	Time	Method
Pregnancy rate	12 weeks	Number of pregnancies

Secondary Outcome Measures

Name	Time	Method
IM/VG oocytes	12 weeks	Number of IM/VG oocytes
Grade I, II, III embryos	12 weeks	Number of embryos of degree I, II, III
Gestational sacs	12 weeks	Number of gestational sacs
Total testosterone	12 weeks	Total testosterone levels
Mature MII oocytes	12 weeks	Number of mature MII oocytes
Days of stimulation	12 weeks	Days of stimulation
Glucose	12 weeks	Glucose levels
Insulin	12 weeks	Insulin levels
Transferred embryos	12 weeks	Number of embryos transferred