Metformin in Assisted Reproduction-MET-AR-study

Overview[ - collapse ][ - ]

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.
ConditionPolycystic Ovary Syndrome
InterventionDrug: Metformin / Placebo treatment for 4 months
PhasePhase 4
SponsorNorwegian University of Science and Technology
Responsible PartyNorwegian University of Science and Technology
ClinicalTrials.gov IdentifierNCT00159575
First ReceivedSeptember 9, 2005
Last UpdatedJanuary 2, 2012
Last verifiedJanuary 2012

Tracking Information[ + expand ][ + ]

First Received DateSeptember 9, 2005
Last Updated DateJanuary 2, 2012
Start DateMarch 2005
Estimated Primary Completion DateApril 2010
Current Primary Outcome MeasuresTo 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]
Current 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]

Descriptive Information[ + expand ][ + ]

Brief TitleMetformin in Assisted Reproduction-MET-AR-study
Official TitleMetformin Treatment Before IVF / ICSI in Non-obese Women With Polycystic Ovarian Syndrome
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 TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
ConditionPolycystic Ovary Syndrome
InterventionDrug: 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
Study Arm (s)Experimental: M: Metformin P: Placebo

Recruitment Information[ + expand ][ + ]

Recruitment StatusTerminated
Estimated Enrollment150
Estimated Completion DateApril 2010
Estimated Primary Completion DateAugust 2009
Eligibility 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
GenderFemale
Ages18 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesNorway

Administrative Information[ + expand ][ + ]

NCT Number NCT00159575
Other Study ID NumbersMET-AR study -PCOS 5
Has Data Monitoring CommitteeNo
Information Provided ByNorwegian University of Science and Technology
Study SponsorNorwegian University of Science and Technology
CollaboratorsNot Provided
Investigators Study Chair: Sven Carlsen, MD,PhD St Olavs Hospital- Endocrinological section
Verification DateJanuary 2012

Locations[ + expand ][ + ]

Fertility UNit- -St Olavs Hospital
Trondheim, Norway, 7046
Sigrun Kjøtrød
Trondheim, Norway, 7006