Back to resultsMetformin in Assisted Reproduction-MET-AR-study
Primary Purpose
Polycystic Ovary Syndrome
Status
Terminated
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Metformin / Placebo treatment for 4 months
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic ovarian syndrome, Clinical pregnancy rate, Oligo- or anovulation
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
Sites / Locations
- Sigrun Kjøtrød
- Fertility UNit- -St Olavs Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
M: Metformin P: Placebo
Arm Description
Outcomes
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
Secondary Outcome Measures
Spontaneous pregnancy rates during the pretreatment period, Spontaneous abortion rates (I or II trim.abortions), Live birth rates,
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)
Full Information
NCT ID
NCT00159575
First Posted
September 9, 2005
Last Updated
January 2, 2012
Sponsor
Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT00159575
Brief Title
Metformin in Assisted Reproduction-MET-AR-study
Official Title
Metformin Treatment Before IVF / ICSI in Non-obese Women With Polycystic Ovarian Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Terminated
Why Stopped
Slow patient recruitment and expiry of study medication(aug2009)
Study Start Date
March 2005 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Polycystic ovarian syndrome, Clinical pregnancy rate, Oligo- or anovulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
M: Metformin P: Placebo
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Metformin / Placebo treatment for 4 months
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven Carlsen, MD,PhD
Organizational Affiliation
St Olavs Hospital- Endocrinological section
Official's Role
Study Chair
Facility Information:
Facility Name
Sigrun Kjøtrød
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
Facility Name
Fertility UNit- -St Olavs Hospital
City
Trondheim
ZIP/Postal Code
7046
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
21606131
Citation
Kjotrod SB, Carlsen SM, Rasmussen PE, Holst-Larsen T, Mellembakken J, Thurin-Kjellberg A, Haapaniemikouru K, Morin-Papunen L, Humaidan P, Sunde A, von During 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. doi: 10.1093/humrep/der154. Epub 2011 May 23.
Results Reference
result
PubMed Identifier
33347618
Citation
Tso LO, Costello MF, Albuquerque LET, Andriolo RB, Macedo CR. Metformin treatment before and during IVF or ICSI in women with polycystic ovary syndrome. Cochrane Database Syst Rev. 2020 Dec 21;12(12):CD006105. doi: 10.1002/14651858.CD006105.pub4.
Results Reference
derived
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Metformin in Assisted Reproduction-MET-AR-study
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