Metformin in Assisted Reproduction-MET-AR-study

Polycystic Ovary Syndrome Clinical Trial

Official title:

Metformin Treatment Before IVF / ICSI in Non-obese Women With Polycystic Ovarian Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00159575
• Other study ID #: MET-AR study -PCOS 5
• Secondary ID: EUDRACTNR. 2004-
• Status: Terminated
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: January 2, 2012
• Start date: March 2005
• Est. completion date: April 2010

Study information

• Verified date: January 2012
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencyNorway: Norwegian Social Science Data ServicesNorway: Directorate of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: April 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

Drug:
• Metformin / 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

Locations

Country	Name	City	State
Norway	Fertility UNit- -St Olavs Hospital	Trondheim
Norway	Sigrun Kjøtrød	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Kjøtrød SB, Carlsen SM, Rasmussen PE, Holst-Larsen T, Mellembakken J, Thurin-Kjellberg A, Haapaniemikouru K, Morin-Papunen L, Humaidan P, Sunde A, von Düring V. Use of metformin before and during assisted reproductive technology in non-obese young inferti — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Spontaneous pregnancy rates during the pretreatment period, Spontaneous abortion rates (I or II trim.abortions), Live birth rates,		Vaginal ultrasound in pregnancy week 7	No
Secondary	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	No