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Metformin in Assisted Reproduction-MET-AR-study

This study has been terminated.
(Slow patient recruitment and expiry of study medication(aug2009))
Sponsor:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00159575
First received: September 9, 2005
Last updated: January 2, 2012
Last verified: January 2012
History of Changes

September 9, 2005
January 2, 2012
March 2005
August 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
To investigate whether four months of Metformin treatment before IVF (in-vitro-fertilisation) or ICSI (intra-cytoplasmatic sperm injection) will increase clinical pregancy rate in normal weight PCOS-women
Complete list of historical versions of study NCT00159575 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 1.Spontaneous pregnancy rates during the pretreatment period
  • 2. Spontaneous abortion rates (I or II trim.abortions)
  • 3. Live birth rates
  • 4. Number of oocytes collected
  • 5. Embryo quality
  • 6. Number of days of gonadotrophin treatment
  • 7. Dose of gonadotrophin, total per cycle and daily
  • 8. s-estradiol on day of hCG-administration
  • 9.Occurrence of ovarian hyperstimulation syndrome (OHSS)
Not Provided
Not Provided
 
Metformin in Assisted Reproduction-MET-AR-study
Metformin Treatment Before IVF / ICSI in Non-obese Women With Polycystic Ovarian Syndrome

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Polycystic Ovary Syndrome
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
Experimental: M: Metformin P: Placebo
Intervention: Drug: Metformin / Placebo treatment for 4 months
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 infertile women with polycystic ovary syndrome: a prospective, randomized, double-blind, multi-centre study. Hum Reprod. 2011 Aug;26(8):2045-53. Epub 2011 May 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
150
April 2010
August 2009   (final data collection date for primary outcome measure)

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
Female
18 Years to 38 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00159575
MET-AR study -PCOS 5, EUDRACTNR. 2004-001124-20
No
Norwegian University of Science and Technology
Norwegian University of Science and Technology
Not Provided
Study Chair: Sven Carlsen, MD,PhD St Olavs Hospital- Endocrinological section
Norwegian University of Science and Technology
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP