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

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

Sponsors

Lead Sponsor: Biosearch S.A.

Source 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.

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.

Overall Status Completed
Start Date 2016-02-01
Completion Date 2017-05-05
Primary Completion Date 2017-05-01
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Pregnancy rate 12 weeks
Secondary Outcome
Measure Time Frame
Mature MII oocytes 12 weeks
IM/VG oocytes 12 weeks
Grade I, II, III embryos 12 weeks
Days of stimulation 12 weeks
Gestational sacs 12 weeks
Transferred embryos 12 weeks
Total testosterone 12 weeks
Glucose 12 weeks
Insulin 12 weeks
Enrollment 60
Condition
Intervention

Intervention Type: Drug

Intervention Name: D-chiro-inositol

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.

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

Intervention Type: Drug

Intervention Name: Myoinositol

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.

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

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.

Gender:

Female

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Nicolás Mendoza, MD, PhD Principal Investigator Professor of Gynecology at the Faculty of Medicine of the University of Granada
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Verification Date

2016-10-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 550 mg of MYO and 150 mg of DCI

Type: Experimental

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.

Label: 550 mg of MYO and 13.8 mg of DCI

Type: Active Comparator

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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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