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

Phase 1

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

• Registration Number: EUCTR2005-000500-13-GB
• Lead Sponsor: niversity of Oxford- Research Services

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-01
• Study Completion: 2009-05-01
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 140

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

• 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 < 16 nmol/L.
3. Biochemical hyperandrogenism with serum testosterone = 3.5 mmol/L and / or free androgen index > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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;<br> Secondary Objective: • Duration of stimulation<br> • Total dose of FSH<br> • Peak estradiol<br> • Endometrial thickness on day of ET<br> • No. of follicles<br> • No. of follicles >14 mm<br> • Ovarian Hyperstimulation Syndrome(OHSS) requiring hospitalisation<br> • No. of oocytes<br> • No. of mature oocytes<br> • No. of oocytes fertilised<br> • No. of embryos >4 cells<br> • Pregnancy rate<br> • Clinical pregnancy rate<br>