Infertility, PCOS, Prognosis for Poor Response
Conditions
Keywords
Gonadotropins, infertility, IVF, metformin, PCOS, poor prognosis, poor responder
Brief summary
Metformin should be administered with caution and could be potentially dangerous in infertile patients with PCOS who show a poor ovarian response and are undergoing gonadotropin-based ovarian stimulation. However, data that address this point are totally lacking. On the basis of these considerations, the aim of the current clinical trial was to test the hypothesis that metformin reduces the ovarian response in infertile patients with PCOS who have a potentially poor ovarian response and who undergo gonadotropin stimulation for IVF cycles.
Detailed description
Primary infertile patients with PCOS older than 35 years and/or with a basal follicle-stimulating hormone (FSH) level higher than 10 IU/L who were scheduled for IVF cycles were enrolled in the study protocol.
Interventions
DRUGMetformin
500 mg three times daily
DRUGPlacebo
1 pill three times daily
Sponsors
University Magna Graecia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* PCOS * Prognosis for poor response * Infertility
Exclusion criteria
* Male factor infertility * Tubal infertility
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of cancellation due to low ovarian response | one month | Number of cancelled cycles/total cycles |
Secondary
| Measure | Time frame |
|---|---|
| Gonadotropins dose | one month |
| Ovulation rate | one month |
| Stimulation length | one month |
| Live-birth rate | nine months |
| Adverse effects | one month |
| pregnancy rate | one month |
Countries
Italy
Outcome results
None listed