Evaluating the equivalence of clomiphene citrate with and without metformin in ovulation induction in PCOS patients

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dc.contributor.authorSiebert T.
dc.contributor.authorKruger T.
dc.contributor.authorLombard C.
dc.date.accessioned2011-05-15T16:16:50Z
dc.date.available2011-05-15T16:16:50Z
dc.date.issued2009
dc.description.abstractObjective: 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.
dc.description.versionArticle
dc.identifier.citationJournal of Assisted Reproduction and Genetics
dc.identifier.citation26
dc.identifier.citation4
dc.identifier.issn10580468
dc.identifier.other10.1007/s10815-009-9304-z
dc.identifier.urihttp://hdl.handle.net/10019.1/13955
dc.subjectclomifene citrate
dc.subjectmetformin
dc.subjectprogesterone
dc.subjectadd on therapy
dc.subjectarticle
dc.subjectclinical trial
dc.subjectcomparative study
dc.subjectcontrolled clinical trial
dc.subjectcontrolled study
dc.subjectdrug dose increase
dc.subjectfemale
dc.subjecthospital
dc.subjecthuman
dc.subjectmajor clinical study
dc.subjectovary polycystic disease
dc.subjectovulation
dc.subjectovulation induction
dc.subjectpriority journal
dc.subjectprospective study
dc.subjectrandomized controlled trial
dc.subjecttherapy effect
dc.subjectuniversity
dc.subjectweight
dc.subjectClomiphene
dc.subjectDrug Therapy, Combination
dc.subjectFemale
dc.subjectFertility Agents, Female
dc.subjectHumans
dc.subjectMetformin
dc.subjectOvulation
dc.subjectOvulation Induction
dc.subjectPolycystic Ovary Syndrome
dc.subjectProspective Studies
dc.titleEvaluating the equivalence of clomiphene citrate with and without metformin in ovulation induction in PCOS patients
dc.typeArticle
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