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
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
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
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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