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Metformin Treatment Before in Vitro Fertilization (IVF) in Women With Ultrasound Evidence of Polycystic Ovaries

This study has been completed.
Sponsor:
Collaborators:
IVF Hammersmith; Imperial College London
Nuture IVF Nottingham; University of Nottingham
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT01046032
First received: January 3, 2010
Last updated: January 8, 2010
Last verified: January 2010
History of Changes
  Purpose

The aim of study was to investigate whether pre-treatment with metformin before and during IVF increases the live birth rate compared to placebo in women with sonographic evidence of polycystic ovaries (PCO), but without any clinical manifestations of polycystic ovary syndrome (PCOS).


Condition Intervention
Polycystic Ovary Syndrome
 Drug: Metformin
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Metformin Treatment Before IVF in Women With Ultrasound Evidence of Polycystic Ovaries; a Prospective, Randomised, Double Blind, Placebo Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Live birth rate [ Time Frame: End of pregnancy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Severe ovarian hyperstimulation syndrome [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 134
Study Start Date: December 2005
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metformin
Drug (including placebo)
 Drug: Metformin
Women were randomised to receive either metformin or placebo starting three weeks before initiation of a GnRH agonist during an IVF treatment cycle (seven weeks prior to oocyte collection and then stopped at oocyte collection). Seventy identical packs of metformin and 70 identical packs of placebo were supplied by DHP Ltd, Crickhowell, Powys (UK) a commercial clinical trial supplier. The randomisation service was provided by DHP Ltd.
Placebo Comparator: Sugar pill
Drug (including placebo)
 Drug: Placebo
Women were randomised to receive either metformin or placebo starting three weeks before initiation of a GnRH agonist during an IVF treatment cycle (seven weeks prior to oocyte collection and then stopped at oocyte collection). Seventy identical packs of metformin and 70 identical packs of placebo were supplied by DHP Ltd, Crickhowell, Powys (UK) a commercial clinical trial supplier. The randomisation service was provided by DHP Ltd.

  Eligibility

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

Inclusion Criteria:

  • Women attending with ovulatory PCO due to undergo IVF/ICSI treatment.
  • First or second cycle of IVF/ICSI.
  • If previously on metformin, a minimum one month washout period was required.
  • Polycystic ovaries diagnosed by ultrasound presence of ≥12 follicles measuring 2-9 mm in diameter in at least one ovary and/or increased ovarian volume (≥10 ml).
  • Written informed consent.

Exclusion Criteria:

  • Clinical manifestations of PCOS, including any of the following:

    1. Oligo- or amenorrhoea with cycles ≥42 days apart.
    2. Anovulation with mid-luteal progesterone <16 nmol/L.
    3. Biochemical hyperandrogenism with serum testosterone ≥3.5 nmol/L and/or free androgen index >5 (FAI = [total testosterone/SHBG] x 100).
    4. Clinical hyperandrogenism with hirsutism or acne requiring treatment at least weekly.
  • Age >38 years.
  • BMI >35 kg/m2.
  • Basal FSH >12 IU/L.
  • Liver disease or ALT >80 IU/L.
  • Renal disease, or creatinine >130 nmol/L.
  • Alcoholism or drug abuse.
  • Diabetes mellitus (evaluated by fasting glucose >6.7mmol/L).
  • Per oral steroid treatment in last month.
  • Cimetidine, anticoagulation, erythromycin, or other macrolides in last month.
  • Hyperprolactinemia (Prolactin >700 mIU/L).
  • Abnormal thyroid function tests (TSH outside of laboratory normal range).
  • Congenital adrenal hyperplasia.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01046032

Locations
United Kingdom
IVF Hammersmith
London, United Kingdom
Nuture IVF Unit
Nottingham, United Kingdom
Oxford Fertility Unit
Oxford, United Kingdom, OX39DU
Sponsors and Collaborators
University of Oxford
IVF Hammersmith; Imperial College London
Nuture IVF Nottingham; University of Nottingham
Investigators
Study Director: Tim J Child, MA MD MRCOG University of Oxford
Principal Investigator: Alexander G Swanton, MBBS MRCOG University of Oxford
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mr Tim Child/Consultant Gynaecologist and Chief Investigator, University of Oxford
ClinicalTrials.gov Identifier: NCT01046032     History of Changes
Other Study ID Numbers: 05/Q1605/87
Study First Received: January 3, 2010
Last Updated: January 8, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Oxford:
Polycystic ovaries
Ovarian stimulation
IVF
Ovarian hyperstimulation
Metformin

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

ClinicalTrials.gov processed this record on June 18, 2013