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

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Placebo; Drug: Metformin

• Registration Number: NCT01046032
• Lead Sponsor: University of Oxford

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2010-01
• Study First Submitted: 2010-01-03
• Study First Submitted QC: 2010-01-08
• Last Update Submitted: 2010-01-08
• Study First Posted: 2010-01-11
• Last Update Posted: 2010-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 134

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugar pill	Placebo	Drug (including placebo)
Metformin	Metformin	Drug (including placebo)

Primary Outcome Measures

Name	Time	Method
Live birth rate	End of pregnancy

Secondary Outcome Measures

Name	Time	Method
Severe ovarian hyperstimulation syndrome	2 months

Trial Locations

Locations (3)

IVF Hammersmith; 🇬🇧 London, United Kingdom

Nuture IVF Unit; 🇬🇧 Nottingham, United Kingdom

Oxford Fertility Unit; 🇬🇧 Oxford, United Kingdom