Metformin treatment before IVF in women with ultrasound evidence of polycystic ovaries; a prospective, randomised, double blind, placebo controlled study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-000500-13-GB

Enrollment

140

Registered

2005-09-01

Start date

2005-08-15

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertile women undergoing IVF with sonographic evidence of polycystic ovaries but without any clinical manifestations of polycystic ovarian syndrome.

Interventions

Trade Name: Metformin Product Name: Metformin Product Code: Metformin Pharmaceutical Form: Capsule* INN or Proposed INN: Metformin Hydro

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Women attending the Oxford fertility unit 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 is required. • Polycystic ovaries diagnosed by ultrasound presence of 12 or more follicles in at least one ovary measuring 2-9 mm in diameter and/or increased ovarian volume (>10 ml) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Clinical manifestations of PCOS. i.e. any of the following – 1. Oligo- or amenorrhoea with cycles = 42 days apart 2. Anovulation with mid-luteal progesterone 5. 4. Clinical hyperandrogenism with hirsutism or acne requiring treatment at least weekly. • Age >38 • BMI >35 • Two or more previous IVF cycles • Basal FSH > 12 iu/L • Liver disease or ALT > 80 iu/l • Renal disease, or creatinine > 130 _mol/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 mU/L) • Abnormal thyroid function tests (TSH outside of laboratory normal range) • Congenital adrenal hyperplasia

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate if metformin treatment before IVF increases the live birth rate in women with ovulatory PCO who do not have other signs of PCOS.;Primary end point(s): Live birth of baby resulting from IVF treatment; Secondary Objective: • Duration of stimulation • Total dose of FSH • Peak estradiol • Endometrial thickness on day of ET • No. of follicles • No. of follicles >14 mm • Ovarian Hyperstimulation Syndrome(OHSS) requiring hospitalisation • No. of oocytes • No. of mature oocytes • No. of oocytes fertilised • No. of embryos >4 cells • Pregnancy rate • Clinical pregnancy rate	—

Measure

Time frame

Main Objective: To investigate if metformin treatment before IVF increases the live birth rate in women with ovulatory PCO who do not have other signs of PCOS.;Primary end point(s): Live birth of baby resulting from IVF treatment; Secondary Objective: • Duration of stimulation • Total dose of FSH • Peak estradiol • Endometrial thickness on day of ET • No. of follicles • No. of follicles >14 mm • Ovarian Hyperstimulation Syndrome(OHSS) requiring hospitalisation • No. of oocytes • No. of mature oocytes • No. of oocytes fertilised • No. of embryos >4 cells • Pregnancy rate • Clinical pregnancy rate

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026