A prospective, randomised, open label trial on the effect of metformin on in-vitro fertilisation outcome in women with polycystic ovary syndrome

A prospective, randomised, open label trial on the effect of metformin on livebirth rates in women with polycystic ovary syndrome undergoing in-vitro fertilization

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000510246

Acronym

Nil

Enrollment

124

Registered

2009-06-29

Start date

2009-07-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

This trial aims to assess whether metformin during ivf treatment and in the first trimester of pregnancy increases livebirth rate and reduces miscarriage rate in women with polycystic ovary syndrome.

Interventions

Metformin with ovarian stimulation to be continued to 12 weeks gestation if pregnant. 500mg per day metformin slow release (xr) oral tablet for 1 week 1000mg of metformin xr for 1 week 1500mg metformin xr for the remainder of the trial. Metformin to be ceased with negative pregnancy test, or the end of the 12th week of pregnancy Ovarian stimulation involves subcuticular injections of follicle stimulating hormones and a gonadotrophin releasing hormone(GnRH) antagonist as per the IVF Australia Antagonist:superovulation protocol. There are 2 different dose regimes for GnRH and this depends on the doctor. An injection of 250 international units of human chorionic gonadotrophin is given 36 hours prior to egg collection

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

20 Years to 38 Years

Healthy volunteers

Inclusion criteria

Polycystic ovary syndrome(PCOS) Infertility Both ovaries present Informed Consent to in-vitro fertilisation treatment Age 20-38years inclusive Use of an Antagonist cycle

Exclusion criteria

Contraindication to metformin Metformin use in previous month Previous participation in the trial Oocyte donor

Outcome results