Polycystic ovary syndrome (PCOS) is a disorder characterized by polycystic ovaries, oligo-amenorrhea and hyperandrogenism. It is the most common endocrine disorder in women of fertile age. PCOS women are an - or oligoovulatory and often suffer from infertility or subfertility. Prevalence estimates vary between three and twenty percent depending on the diagnostic criteria used and the population studied. A prevalence of five to seven percent has been reported in Caucasian women.
Conditions
Interventions
Sponsors
Sigrun Kjøtrød
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: More than one year of infertility in PCOS-women planned for IVF og ICSI - First or second cycle of IVF og ICSI treatment. - Age below 38 years at inclusion. - BMI below 28 kg/m2 at inclusion. - Patient willing to be randomised to 4 month treatment with metformin or placebo. - If previously on methformin, a 1 month wash-out period is required. - PCOS diagnosis based on the revised ESHRE/ASMR-2003 (Rotterdam)-criteriae; fullfilling at least two of the following three criteriae: - Oligoamenorrhea - Hyperandrogenism - Polycystic ovaries by ultrasound Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: More than one previous IVF cycle - Patients not suitable for starting dose 112.5 IE Gonal-F. - Basal s-FSH above 10 IE/L - Known liver disease, or s-ALAT above 80 IU/L - Known renal disease, os s-kreatinin obove 130 mmol/L - Known alcoholism or drug abuse - known diabetes mellitus, or fasting serum-glucosis above 6.7 nmol/L - Peroral steroid hormone treatment - Treatment with cimetidin, anticoagulantia, erythromycin or other macrolides - Hyperprolactinemia (se-PRL above 700 IE/L) - Abnormal thyroid function tests - Congenital adrenal hyperplasia - Androgen secreting tumors - Cushing disease - Unfit to participate of any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does methormin treatment before IVF/ICSI in women with polycystic ovarian syndrome and normal body weight (BMI below 28 kg/m2)increase clinical pregnancy rate in IVF/ICSI? Clinical pregnancy rate defined as a verified intrauterine gestational sack week 7 in pregnancy.;Secondary Objective: Number of oocytes collected - Embryo quality - Number of days with gonadotropin treatment in IVF cycle (ie. costs) - Dose of gonodotrophin, total pr cycle and daily - S-estradiol on day of hCG-injection - Occurrence of Ovarian Hyperstimulation Syndrome (OHSS) - Spontaneous pregnancy rates during pretreatment period. - Spontaneous abortion rates - Live birth rates;Primary end point(s): Clinical pregnancy rate following IVF or ICSI treatment in normal weight PCOS -women. Clinical pregnancy rate defined by an intrauterine gestational sack week 7 in pregnancy. | — |
Countries
Denmark, Finland, Sweden, United Kingdom
Outcome results
None listed