Metformin in Assisted Reproduction-MET-AR-study

Norwegian University of Science and Technology

Status and phase: Terminated; Phase 4

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Metformin / Placebo treatment for 4 months

Study type: Interventional

Funder types: Other

Identifiers

NCT00159575

MET-AR study -PCOS 5

EUDRACTNR. 2004-001124-20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 1 patient group

M: Metformin P: Placebo

Experimental group

Treatment:

Drug: Metformin / Placebo treatment for 4 months