Polycystic Ovary Syndrome
Conditions
Keywords
Polycystic ovarian syndrome, Clinical pregnancy rate, Oligo- or anovulation
Brief summary
Aim of study: To investigate whether four months of metformin treatment before IVF (in-vitro-fertilisation) or ICSI (intra-cytoplasmic-sperm-injection) might increase clinical pregnancy rate in normal-weight (body mass index \[BMI\] below 28 kg/m3) in PCOS (polycystic ovarian syndrome) women.
Detailed description
PCOS is an hormonal disease including hyperandrogenism, oligo-or anovulation and/or polycystic ovaries by ultrasound. PCOS women often suffer insulin resistance or even diabetes risk as well as a full blown metabolic disease. These women often suffer infertility due to their lack of regular ovulations. Metformin is a well known anti-diabetic drug, and in some PCOS women metformin might decrease the hyperandrogenism, improve insulin resistance and give more regular ovulations. Thereby increase chance of pregnancy. Our hypothesis is that metformin will increase clinical pregnancy rates both spontaneously and following IVF/ICSI.
Interventions
DRUGMetformin / Placebo treatment for 4 months
M: Metformin 2000mg daily- 12-14 weeks of pretreatment + metformin 2000mg daily through conventional IVF ending on the day of pregnancy test; IE. 14 days after embryo transfer. P: Or identical placebo treatment for the same period
Sponsors
Norwegian University of Science and Technology
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 38 Years
Healthy volunteers
Yes
Inclusion criteria
* Fulfilling Rotterdam criteria for PCOS * Infertility more than 1 year * First or second cycle of IVF/ICSI treatment * Age below 38 years at inclusion * BMI below 28 kg/m3 at inclusion * Willing to be randomised to 4 months metformin or placebo * Signed written informed consent
Exclusion criteria
* Not suitable for starting dose 112.5 IE * Basal FSH above 10 IU/L * Known renal disease or s-creatinine above 110 umol/L * Known liver disease or s-ALAT above 80 IU/L * Known alcoholism or drug abuse * Known diabetes mellitus or fasting plasma glucose above 7 mmol/L * Corticosteroid treatment (oral) * Treatment with cimetidine, anticoagulants, erythromycin or other macrolides * Hyperprolactinemia (PRL above 700 mIU/L) * Abnormal thyroid function tests * Known congenital adrenal hyperplasia * Androgen secreting tumours * Cushing syndrome * Metformin treatment within the last one month prior to screening * Unfit to participate for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate whether four months of Metformin treatment before IVF (in-vitro-fertilisation) or ICSI (intra-cytoplasmic sperm injection) will increase clinical pregnancy rate in normal weight PCOS-women | Vaginal ultrasound in pregnancy week 7 |
Secondary
| Measure | Time frame |
|---|---|
| Spontaneous pregnancy rates during the pretreatment period, Spontaneous abortion rates (I or II trim.abortions), Live birth rates, | Vaginal ultrasound in pregnancy week 7 |
| Number of oocytes collected, Embryo quality, Number of days of gonadotrophin treatment, Dose of gonadotrophin, total per cycle and daily, s-estradiol on day of hCG-administration, Occurrence of ovarian hyperstimulation syndrome (OHSS) | All data evaluated at study end, from september 2009 onwards |
Countries
Norway
Outcome results
None listed