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

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ClinicalTrials.gov Identifier: NCT03201601
Recruitment Status : Completed
First Posted : June 28, 2017
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Biosearch S.A.

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.


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Study Type : Interventional  (Clinical Trial)
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 : February 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 5, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Inositol

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




Primary Outcome Measures :
  1. Pregnancy rate [ Time Frame: 12 weeks ]
    Number of pregnancies


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201601


Sponsors and Collaborators
Biosearch S.A.
Investigators
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Principal Investigator: Nicolás Mendoza, MD, PhD Professor of Gynecology at the Faculty of Medicine of the University of Granada

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Responsible Party: Biosearch S.A.
ClinicalTrials.gov Identifier: NCT03201601     History of Changes
Other Study ID Numbers: C015
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Biosearch S.A.:
Polycystic ovarian syndrome
D-chiro-inositol
Fertility

Additional relevant MeSH terms:
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Inositol
Syndrome
Infertility
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs