Clinical trial NCT03201601: Evaluation of the Mixture Myoinositol:D-chiro-inositol 3.6:1 in Women With Polycystic Ovary Syndrome
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Polycystic Ovarian Syndrome
Infertility
Keywords: Polycystic ovarian syndrome
D-chiro-inositol
Fertility
Lead sponsor: Biosearch S.A.
Sponsor class: INDUSTRY
First posted: 2017-06-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pregnancy rate
timeFrame: 12 weeks
Secondary outcomes:
measure: Mature MII oocytes
timeFrame: 12 weeks
measure: IM/VG oocytes
timeFrame: 12 weeks
measure: Grade I, II, III embryos
timeFrame: 12 weeks
measure: Days of stimulation
timeFrame: 12 weeks
measure: Gestational sacs
timeFrame: 12 weeks
measure: Transferred embryos
timeFrame: 12 weeks
measure: Total testosterone
timeFrame: 12 weeks
measure: Glucose
timeFrame: 12 weeks
measure: Insulin
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Professor of Gynecology at the Faculty of Medicine of the University of Granada
name: Nicolás Mendoza, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: