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Completed

NCT Number: NCT03201601

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

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.

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Key information

Conditions

Polycystic Ovarian Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Infertility Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

D-chiro-inositol

Drug

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

Myoinositol

Drug

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

Primary outcomes

  1. Pregnancy rate

    Time frame: 12 weeks

    Number of pregnancies

Secondary outcomes

  1. Mature MII oocytes

    Time frame: 12 weeks

    Number of mature MII oocytes

  2. IM/VG oocytes

    Time frame: 12 weeks

    Number of IM/VG oocytes

  3. Grade I, II, III embryos

    Time frame: 12 weeks

    Number of embryos of degree I, II, III

  4. Days of stimulation

    Time frame: 12 weeks

    Days of stimulation

  5. Gestational sacs

    Time frame: 12 weeks

    Number of gestational sacs

  6. Transferred embryos

    Time frame: 12 weeks

    Number of embryos transferred

  7. Total testosterone

    Time frame: 12 weeks

    Total testosterone levels

  8. Glucose

    Time frame: 12 weeks

    Glucose levels

  9. Insulin

    Time frame: 12 weeks

    Insulin levels

Sponsors and collaborators

Lead sponsor

Biosearch S.A.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 28, 2017
Registry last updated
Jan 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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