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Clinical Trials/NCT01046032
NCT01046032CompletedNot Applicable

Metformin Treatment Before IVF in Women With Ultrasound Evidence of Polycystic Ovaries; a Prospective, Randomised, Double Blind, Placebo Study

University of Oxford3 sites in 1 country134 target enrollmentStarted: December 2005Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
134
Locations
3
Primary Endpoint
Live birth rate
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
— to 38 Years (Child, Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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:
  • •Oligo- or amenorrhoea with cycles ≥42 days apart.
  • •Anovulation with mid-luteal progesterone <16 nmol/L.
  • •Biochemical hyperandrogenism with serum testosterone ≥3.5 nmol/L and/or free androgen index >5 (FAI = [total testosterone/SHBG] x 100).
  • •Clinical hyperandrogenism with hirsutism or acne requiring treatment at least weekly.
  • •Age >38 years.
  • •BMI >35 kg/m
  • •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.

Arms & Interventions

Metformin

Active Comparator

Drug (including placebo)

Intervention: Metformin (Drug)

Sugar pill

Placebo Comparator

Drug (including placebo)

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Live birth rate

Time Frame: End of pregnancy

Secondary Outcomes

  • Severe ovarian hyperstimulation syndrome(2 months)

Investigators

Sponsor Class
Other

Study Sites (3)

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