Evaluation of the Mixture Myoinositol:D-chiro-inositol 3.6:1 in Women With Polycystic Ovary Syndrome
NCT ID: NCT03201601
Last Updated: 2019-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2016-02-29
2017-05-05
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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.
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.
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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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.
18 Years
FEMALE
No
Sponsors
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Biosearch S.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Nicolás Mendoza, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Professor of Gynecology at the Faculty of Medicine of the University of Granada
Other Identifiers
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C015
Identifier Type: -
Identifier Source: org_study_id
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