Live birth rate after metformin and clomiphene vs clomiphene alone in polycystic ovary syndrome (PCOS): a randomized, double-blind, placebo-controlled trial.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000027718

Acronym

nil

Enrollment

Registered

2013-01-10

Start date

1998-12-09

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

The study was approved in 1998 by the Royal Brisbane Human Research Ethics Committee.

Interventions

standard preparation metformin, 500mg, orally, three times per day (TDS) and clomiphene citrate 25mg-150mg (dose determined by treating clinician), orally, daily. Clomiphene citrate was administered from day 3-7 of the menstrual cycle. Metformin was administered daily continuously or until pregnancy was confirmed via a beta-hcg.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 40 Years

Healthy volunteers

Inclusion criteria

women with polycystic ovary syndrome, desiring pregnancy, with subfertility

Exclusion criteria

Women were excluded from the study if they had other causes of anovulation (specifically hyperprolactinaemia, hypothyroidism and congenital adrenal hyperplasia), diabetes mellitus or if the semen analysis of their partner indicated male factor subfertility

Outcome results