Metformin in Assisted Reproduction-MET-AR-study

Phase 4

Terminated

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Metformin / Placebo treatment for 4 months

• Registration Number: NCT00159575
• Lead Sponsor: Norwegian University of Science and Technology

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.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-12
• Primary Completion: 2009-08
• Study Completion: 2010-04
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-02
• Last Update Posted: 2012-01-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
M: Metformin P: Placebo	Metformin / Placebo treatment for 4 months	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Sigrun Kjøtrød; 🇳🇴 Trondheim, Norway

Fertility UNit- -St Olavs Hospital; 🇳🇴 Trondheim, Norway