Evaluating the equivalence of clomiphene citrate with and without metformin in ovulation induction in PCOS patients
Date
2009
Authors
Siebert T.
Kruger T.
Lombard C.
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Abstract
Objective: To evaluate the benefit of Metfomin added to Clomiphene Citrate in a primary ovulation induction protocol in PCOS patients Design: Prospective randomised controlled study Setting: Tygerberg Academic Hospital, Stellenbosch University and the Institute of Reproductive Medicine at Vincent Pallotti Hospital, Cape Town Patients: 107 patients presenting with PCOS Study: Group A was pre-treated with metformin 850 mg twice a day for at least 6 weeks before clomiphene was added and the metformin was used throughout the study period. Group B received clomiphene without pre-treatment with metformin. In both groups clomiphene was given at a starting dose of 50 mg day 4-8 and increase with increments of 50 mg to a maximum of 150 mg if no response was achieved. Results: The ovulation rate achieved in women in the M+C/C arm was 34/52 (65.4%) compared to 36/55 (65.5%) in the C/C arm. The treatment effect ((M+C/C) - C/C) is 0% with 95% confidence interval of -18.1% to 18%. The per protocol ovulation results were 34/42 (81%) in the M+C/C arm compared to 36/48 (75%) in the C/C arm. The ovulation rate difference was 6% with 95% confidence interval -11% to 22%. In a comparison of successful ovulating versus non-ovulating women from the trial the following were significant baseline determinants: lower median weight in the ovulating group (77 kg versus 86 kg, p∈=∈.021), lower median bmi (29.0 versus 32.9, p∈=∈.009), lower median DHEAS at baseline (4.6 compared to 7.0, p∈=∈.049), lower median 17OH-progesterone (2.2 versus 4.6, p∈=∈.027) and higher baseline median SHBG ( 37.8 compared to 28.5, p∈=∈.036). Conclusion: Although identical ovulation rates were observed in both arms equivalence could not be concluded with respect to the specified criteria. © 2009 Springer Science+Business Media, LLC.
Description
Keywords
clomifene citrate, metformin, progesterone, add on therapy, article, clinical trial, comparative study, controlled clinical trial, controlled study, drug dose increase, female, hospital, human, major clinical study, ovary polycystic disease, ovulation, ovulation induction, priority journal, prospective study, randomized controlled trial, therapy effect, university, weight, Clomiphene, Drug Therapy, Combination, Female, Fertility Agents, Female, Humans, Metformin, Ovulation, Ovulation Induction, Polycystic Ovary Syndrome, Prospective Studies
Citation
Journal of Assisted Reproduction and Genetics
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