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

Study Overview
=================
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.

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

Conditions
-----------------
Polycystic Ovarian Syndrome, Infertility

Intervention / Treatment
-----------------
* Drug: D-chiro-inositol
* Drug: Myoinositol


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 550 mg of MYO and 150 mg of DCI<br>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<br>* 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.<br>* Other names: Cis-1,2,4-trans-3,5,6-cyclohexanehexol;Drug: Myoinositol<br>* 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.<br>* Other names: cis-1,2,3,5-trans-4,6-cyclohexanehexol;|
| Active Comparator: 550 mg of MYO and 13.8 mg of DCI<br>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<br>* 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.<br>* Other names: Cis-1,2,4-trans-3,5,6-cyclohexanehexol;Drug: Myoinositol<br>* 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.<br>* Other names: cis-1,2,3,5-trans-4,6-cyclohexanehexol;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate | Number of pregnancies | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mature MII oocytes | Number of mature MII oocytes | 12 weeks | 
| IM/VG oocytes | Number of IM/VG oocytes | 12 weeks | 
| Grade I, II, III embryos | Number of embryos of degree I, II, III | 12 weeks | 
| Days of stimulation | Days of stimulation | 12 weeks | 
| Gestational sacs | Number of gestational sacs | 12 weeks | 
| Transferred embryos | Number of embryos transferred | 12 weeks | 
| Total testosterone | Total testosterone levels | 12 weeks | 
| Glucose | Glucose levels | 12 weeks | 
| Insulin | Insulin levels | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polycystic ovarian syndrome, D-chiro-inositol, Fertility