Metformin in Assisted Reproduction-MET-AR-study

Phase 4TerminatedNCT00159575

Norwegian University of Science and Technology150 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

Polycystic Ovary Syndrome

Interventions

Metformin / Placebo treatment for 4 monthsDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 38 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Sigrun Kjøtrød

Trondheim, Norway

Fertility UNit- -St Olavs Hospital

Trondheim, Norway

Outcomes

Primary Outcomes

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

Time frame: Vaginal ultrasound in pregnancy week 7

Secondary Outcomes

Spontaneous pregnancy rates during the pretreatment period, Spontaneous abortion rates (I or II trim.abortions), Live birth rates,

Time frame: 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)

Time frame: All data evaluated at study end, from september 2009 onwards

Data from ClinicalTrials.gov

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