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

Primary Purpose

Polycystic Ovarian Syndrome, Infertility

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
D-chiro-inositol
Myoinositol
Sponsored by
Biosearch S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovarian Syndrome focused on measuring Polycystic ovarian syndrome, D-chiro-inositol, Fertility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    550 mg of MYO and 150 mg of DCI

    550 mg of MYO and 13.8 mg of DCI

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Pregnancy rate
    Number of pregnancies

    Secondary Outcome Measures

    Mature MII oocytes
    Number of mature MII oocytes
    IM/VG oocytes
    Number of IM/VG oocytes
    Grade I, II, III embryos
    Number of embryos of degree I, II, III
    Days of stimulation
    Days of stimulation
    Gestational sacs
    Number of gestational sacs
    Transferred embryos
    Number of embryos transferred
    Total testosterone
    Total testosterone levels
    Glucose
    Glucose levels
    Insulin
    Insulin levels

    Full Information

    First Posted
    June 27, 2017
    Last Updated
    January 9, 2019
    Sponsor
    Biosearch S.A.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03201601
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2016 (undefined)
    Primary Completion Date
    May 2017 (Actual)
    Study Completion Date
    May 5, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Biosearch S.A.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Polycystic Ovarian Syndrome, Infertility
    Keywords
    Polycystic ovarian syndrome, D-chiro-inositol, Fertility

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    550 mg of MYO and 150 mg of DCI
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    550 mg of MYO and 13.8 mg of DCI
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    D-chiro-inositol
    Other Intervention Name(s)
    Cis-1,2,4-trans-3,5,6-cyclohexanehexol
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Myoinositol
    Other Intervention Name(s)
    cis-1,2,3,5-trans-4,6-cyclohexanehexol
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Pregnancy rate
    Description
    Number of pregnancies
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Mature MII oocytes
    Description
    Number of mature MII oocytes
    Time Frame
    12 weeks
    Title
    IM/VG oocytes
    Description
    Number of IM/VG oocytes
    Time Frame
    12 weeks
    Title
    Grade I, II, III embryos
    Description
    Number of embryos of degree I, II, III
    Time Frame
    12 weeks
    Title
    Days of stimulation
    Description
    Days of stimulation
    Time Frame
    12 weeks
    Title
    Gestational sacs
    Description
    Number of gestational sacs
    Time Frame
    12 weeks
    Title
    Transferred embryos
    Description
    Number of embryos transferred
    Time Frame
    12 weeks
    Title
    Total testosterone
    Description
    Total testosterone levels
    Time Frame
    12 weeks
    Title
    Glucose
    Description
    Glucose levels
    Time Frame
    12 weeks
    Title
    Insulin
    Description
    Insulin levels
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nicolás Mendoza, MD, PhD
    Organizational Affiliation
    Professor of Gynecology at the Faculty of Medicine of the University of Granada
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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