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

Sponsor

Biosearch S.A. (Industry)

Overall Status

Completed

CT.gov ID

NCT03201601

Collaborator

(none)

Enrollment

Arms

15.1

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovarian Syndrome Infertility	Drug: D-chiro-inositol Drug: Myoinositol	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

May 1, 2017

Actual Study Completion Date :

May 5, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 550 mg of MYO and 150 mg of DCI Volunteers will take twice at day for 12 weeks a capsule containing 550 mg of myo-inositol and 150 mg of D-chiro-inositol.	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. Other Names: Cis-1,2,4-trans-3,5,6-cyclohexanehexol Drug: 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. Other Names: cis-1,2,3,5-trans-4,6-cyclohexanehexol
Active Comparator: 550 mg of MYO and 13.8 mg of DCI 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.	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. Other Names: Cis-1,2,4-trans-3,5,6-cyclohexanehexol Drug: 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. Other Names: cis-1,2,3,5-trans-4,6-cyclohexanehexol

Arm

Intervention/Treatment

Experimental: 550 mg of MYO and 150 mg of DCI

Volunteers will take twice at day for 12 weeks a capsule containing 550 mg of myo-inositol and 150 mg of D-chiro-inositol.

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.

Other Names:

Cis-1,2,4-trans-3,5,6-cyclohexanehexol

Drug: 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.

Other Names:

cis-1,2,3,5-trans-4,6-cyclohexanehexol

Active Comparator: 550 mg of MYO and 13.8 mg of DCI

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.

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.

Other Names:

Cis-1,2,4-trans-3,5,6-cyclohexanehexol

Drug: 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.

Other Names:

cis-1,2,3,5-trans-4,6-cyclohexanehexol

Outcome Measures

Primary Outcome Measures

Pregnancy rate [12 weeks]
Number of pregnancies

Secondary Outcome Measures

Mature MII oocytes [12 weeks]
Number of mature MII oocytes
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
Days of stimulation [12 weeks]
Days of stimulation
Gestational sacs [12 weeks]
Number of gestational sacs
Transferred embryos [12 weeks]
Number of embryos transferred
Total testosterone [12 weeks]
Total testosterone levels
Glucose [12 weeks]
Glucose levels
Insulin [12 weeks]
Insulin levels

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.