Comparison of clomiphene citrate, metformin, or the combination of both for first-line ovulation induction, achievement of pregnancy, and live birth in Asian women with polycystic ovary syndrome: a randomized controlled trial

Zain, Murizah Mohd; Jamaluddin, Ridzuan; Ibrahim, Adibah; Norman, Robert J.

doi:10.1016/j.fertnstert.2007.12.002

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Volume 91, Issue 2 , Pages 514-521, February 2009

Comparison of clomiphene citrate, metformin, or the combination of both for first-line ovulation induction, achievement of pregnancy, and live birth in Asian women with polycystic ovary syndrome: a randomized controlled trial

Murizah Mohd Zain, M.D., M.Med. (O&G)
- Department of Obstetric and Gynaecology, Alor Setar Hospital, Kedah, Malaysia
- Research Centre of Reproductive Health, School of Paediatrics and Reproductive Health, University of Adelaide, South Australia, Australia
- Reprint requests: Murizah Mohd Zain, M.D., University of Adelaide, School of Pediatric and Reproductive Health, 6th floor, Medical School North, Adelaide, South Australia 5005 Australia (FAX: 618-83036100).
Ridzuan Jamaluddin, M.D.
- Department of Obstetric and Gynaecology, Science University Hospital, Kelantan, Malaysia
Adibah Ibrahim, M.D., M.Med. (O&G)
- Department of Obstetric and Gynaecology, Science University Hospital, Kelantan, Malaysia
Robert J. Norman, M.D., F.R.A.N.Z.C.O.G., F.R.C.O.G., F.R.C.P.A.
- Research Centre of Reproductive Health, School of Paediatrics and Reproductive Health, University of Adelaide, South Australia, Australia

Received 5 October 2007; received in revised form 7 December 2007; accepted 7 December 2007. published online 05 March 2008.

Objective

To determine the first-line medication to be used in anovulatory patients with polycystic ovary syndrome (PCOS) for ovulation induction and pregnancy achievement.

Design

Randomized controlled trial.

Setting

Infertility unit of a public hospital.

Patient(s)

One hundred fifteen newly diagnosed patients with PCOS based on ESHRE/ASRM criteria.

Intervention(s)

These patients were assigned to three groups: group 1 (38 patients) received 500 mg of metformin three times a day; group 2 (39 patients) received clomiphene citrate (CC) at an incremental dose; group 3 (38 patients) received both medications.

Main Outcome Measure(s)

Rates of ovulation, pregnancy (PR), and live birth.

Result(s)

The ovulation rate was 23.7% in the metformin group, 59% in the CC group, and 68.4% in the combination treatment group. This was translated into a similar PR and live birth rate, which were higher in the CC and combination groups compared to the metformin group (PR: 7.9%, 15.4%, and 21.1%; live birth rate: 7.9%, 15.4%, and 18.4% in metformin, CC, and combination treatment groups, respectively), although statistically the differences were not significant. There were no multiple pregnancies and the rate of spontaneous first trimester loss was similar to the general population.