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

Infertility Clinical Trial

Official title:

Comparison of the Effect of a Combination of Myoinositol:D-chiro-inositol With Low Proportion of DCI (40:1) Versus a Combination With a Higher Proportion of DCI (3.6:1) in the Oocyte Quality and Pregnancy Rates in Women With PCOS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03201601
• Other study ID #: C015
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 2016
• Est. completion date: May 5, 2017

Study information

• Verified date: October 2016
• Source: Biosearch S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 5, 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Polycystic Ovarian Syndrome
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• D-chiro-inositol
Each participant will consume 2 capsules daily of each treatment, in the morning and at night without any restriction in the diet nor in their habits of life. The treatment will last 12 weeks.
• Myoinositol
Each participant will consume 2 capsules daily of each treatment, in the morning and at night without any restriction in the diet nor in their habits of life. The treatment will last 12 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biosearch S.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate	Number of pregnancies	12 weeks
Secondary	Mature MII oocytes	Number of mature MII oocytes	12 weeks
Secondary	IM/VG oocytes	Number of IM/VG oocytes	12 weeks
Secondary	Grade I, II, III embryos	Number of embryos of degree I, II, III	12 weeks
Secondary	Days of stimulation	Days of stimulation	12 weeks
Secondary	Gestational sacs	Number of gestational sacs	12 weeks
Secondary	Transferred embryos	Number of embryos transferred	12 weeks
Secondary	Total testosterone	Total testosterone levels	12 weeks
Secondary	Glucose	Glucose levels	12 weeks
Secondary	Insulin	Insulin levels	12 weeks