NCT00159575

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2005

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

January 5, 2012

Status Verified

January 1, 2012

Enrollment Period

4.4 years

First QC Date

September 9, 2005

Last Update Submit

January 2, 2012

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic ovarian syndromeClinical pregnancy rateOligo- or anovulation

Outcome Measures

Primary Outcomes (1)

  • 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

    Vaginal ultrasound in pregnancy week 7

Secondary Outcomes (2)

  • Spontaneous pregnancy rates during the pretreatment period, Spontaneous abortion rates (I or II trim.abortions), Live birth rates,

    Vaginal ultrasound in pregnancy week 7

  • 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)

    All data evaluated at study end, from september 2009 onwards

Study Arms (1)

M: Metformin P: Placebo

EXPERIMENTAL
Drug: Metformin / Placebo treatment for 4 months

Interventions

Metformin / Placebo treatment for 4 monthsDRUG

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

M: Metformin P: Placebo

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Fulfilling Rotterdam criteria for PCOS
  • Infertility more than 1 year
  • First or second cycle of IVF/ICSI treatment
  • Willing to be randomised to 4 months metformin or placebo
  • Signed written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sigrun Kjøtrød

Trondheim, 7006, Norway

Location

Fertility UNit- -St Olavs Hospital

Trondheim, 7046, Norway

Location

Related Publications (2)

  • 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.

    PMID: 21606131RESULT

  • 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.

    PMID: 33347618DERIVED

MeSH Terms

Conditions

Polycystic Ovary SyndromeAnovulation

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Sven Carlsen, MD,PhD

    St Olavs Hospital- Endocrinological section

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 12, 2005

Study Start

March 1, 2005

Primary Completion

August 1, 2009

Study Completion

April 1, 2010

Last Updated

January 5, 2012

Record last verified: 2012-01

Locations

NO(2)