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
  Purpose

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.


Condition Intervention Phase
Polycystic Ovary Syndrome
Drug: Metformin / Placebo treatment for 4 months
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Metformin Treatment Before IVF / ICSI in Non-obese Women With Polycystic Ovarian Syndrome

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 150
Study Start Date: March 2005
Study Completion Date: April 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: M: Metformin P: Placebo 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159575

Locations
Norway
Fertility UNit- -St Olavs Hospital
Trondheim, Norway, 7046
Sigrun Kjøtrød
Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Study Chair: Sven Carlsen, MD,PhD St Olavs Hospital- Endocrinological section
  More Information

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00159575     History of Changes
Other Study ID Numbers: MET-AR study -PCOS 5, EUDRACTNR. 2004-001124-20
Study First Received: September 9, 2005
Last Updated: January 2, 2012
Health Authority: Norway: Norwegian Medicines Agency
Norway: Norwegian Social Science Data Services
Norway: Directorate of Health

Keywords provided by Norwegian University of Science and Technology:
Polycystic ovarian syndrome
Clinical pregnancy rate
Oligo- or anovulation

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Disease
Pathologic Processes
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014