Metformin in Assisted Reproduction-MET-AR-Study - Full Text View

Sponsored by:	Norwegian University of Science and Technology
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00159575

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 IV

Drug Information available for: Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Metformin Treatment Before IVF / ICSI in Non-Obese Women With Polycystic Ovarian Syndrome

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 ]

Estimated Enrollment:	300
Study Start Date:	March 2005
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
M: Metformin P: Placebo: Placebo Comparator	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

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

Contacts

Contact: Sigrun Beate Kjøtrød, MD	+47 72573812 ext +47 93458952	sigrun.kjotrod@stolav.no
Contact: Louise Reinertsen, study nurse	+47 72573993 ext +47 90034759	Louise.Reinertsen@stolav.no

Locations

Norway
Fertility UNit- -St Olavs Hospital	Recruiting
Trondheim, Norway, 7046
Contact: Sigrun B Kjøtrød, MD +47 72573812 ext +4793458952 sigrun.kjotrod@stolav.no
Contact: Louise Reinertsen, study nurse 72573993 ext +4790034759 Louise.Reinertsen@stolav.no
Sigrun Kjøtrød	Recruiting
Trondheim, Norway, 7006
Contact: Sigrun B Kjøtrød, MD +4772573812 ext +4793458952 Sigrun.Kjotrod@Stolav.no
Contact: Louise Reinertsen, Study Nurse +47 72573993 ext +4790034759 Louise.Reinertsen@Stolav.no

Sponsors and Collaborators

Norwegian University of Science and Technology

Investigators

Study Chair:

Sven Carlsen, MD,PhD

St Olavs Hospital- Endocrinological section

More Information

No publications provided

Responsible Party:	IVF-Unit - Trondheim University Hospital ( Dr. Sigrun B Kjøtrød )
Study ID Numbers:	MET-AR study -PCOS 5, EUDRACTNR. 2004-001124-20
Study First Received:	September 9, 2005
Last Updated:	February 5, 2008
ClinicalTrials.gov Identifier:	NCT00159575 History of Changes
Health Authority:	Norway: Norwegian Medicines Agency; Norway: Norwegian Social Science Data Services; Norway: Directorate for Health and Social Affairs

Keywords provided by Norwegian University of Science and Technology:

Polycystic ovarian syndrome
Clinical pregnancy rate
Oligo- or anovulation

Study placed in the following topic categories:

Genital Diseases, Female
Hypoglycemic Agents
Gonadal Disorders
Metformin
Polycystic Ovary Syndrome
Endocrine System Diseases

Endocrinopathy
Ovarian Diseases
Cysts
Anovulation
Ovarian Cysts
Polycystic Ovarian Syndrome

Additional relevant MeSH terms:

Disease
Gonadal Disorders
Physiological Effects of Drugs
Metformin
Endocrine System Diseases
Ovarian Diseases
Cysts
Pharmacologic Actions

Adnexal Diseases
Genital Diseases, Female
Neoplasms
Hypoglycemic Agents
Pathologic Processes
Syndrome
Polycystic Ovary Syndrome
Ovarian Cysts

ClinicalTrials.gov processed this record on May 06, 2009