Polycystic Ovary Syndrome
Conditions
Keywords
Polycystic ovaries, Ovarian stimulation, IVF, Ovarian hyperstimulation, Metformin
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).
Interventions
DRUGMetformin
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.
DRUGPlacebo
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.
Sponsors
Imperial College London
University of Nottingham
University of Oxford
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 38 Years
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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live birth rate | End of pregnancy |
Secondary
| Measure | Time frame |
|---|---|
| Severe ovarian hyperstimulation syndrome | 2 months |
Countries
United Kingdom
Outcome results
None listed