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

Biosearch Life

Status and phase: Completed; Phase 3; Phase 2

Conditions: Infertility; Polycystic Ovarian Syndrome

Treatments: Drug: D-chiro-inositol; Drug: Myoinositol

Study type: Interventional

Funder types: Industry

Identifiers

NCT03201601

C015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

550 mg of MYO and 150 mg of DCI

Experimental group

Description:

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

Treatment:

Drug: Myoinositol

Drug: D-chiro-inositol

550 mg of MYO and 13.8 mg of DCI

Active Comparator group

Description:

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.

Treatment:

Drug: Myoinositol

Drug: D-chiro-inositol