Polycystic Ovarian Syndrome, Infertility
Conditions
Keywords
Polycystic ovarian syndrome, D-chiro-inositol, Fertility
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.
Interventions
DRUGD-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.
DRUGMyoinositol
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.
Sponsors
Biosearch S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy rate | 12 weeks | Number of pregnancies |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IM/VG oocytes | 12 weeks | Number of IM/VG oocytes |
| Grade I, II, III embryos | 12 weeks | Number of embryos of degree I, II, III |
| Days of stimulation | 12 weeks | Days of stimulation |
| Gestational sacs | 12 weeks | Number of gestational sacs |
| Mature MII oocytes | 12 weeks | Number of mature MII oocytes |
| Total testosterone | 12 weeks | Total testosterone levels |
| Glucose | 12 weeks | Glucose levels |
| Insulin | 12 weeks | Insulin levels |
| Transferred embryos | 12 weeks | Number of embryos transferred |
Outcome results
None listed