A comparison between clomiphene/FSH cycles, with and without ganirelix, in poor responder IVF patients.

Abstract

Objective: Initial phase III trials comparing the GnRH antagonist, ganirelix acetate, with the GnRH agonist, leuprolide acetate, showed similar pregnancy rates in IVF patients; however, inclusion criteria for this trial required patients to be ≤39 years old and with FSH levels ≤ 10 IU/L. Poor responder infertility patients, who may not meet these criteria, have previously benefited from the traditional clomiphene/FSH ovarian stimulation. This study compares clomiphene/FSH pregnancy outcomes in poor responder IVF patients, treated with or without ganirelix therapy. Design: Retrospective analysis of IVF clinical data. Materials/Methods: Two hundred fifty-five poor responder IVF patients with prior failed leuprolide treated cycles were enrolled in a clomiphene (100 mg cycle days 2–6), recombinant FSH (cycle day 2 until hCG Rx) protocol. Seventy-eight patients were additionally prescribed ganirelix (0.25 mg qD, cycle day 8 until hCG Rx); the remaining 177 patients did not use ganirelix. Blood samples were obtained on cycle days 2,5 and daily from cycle day 8 until oocyte retrieval. Some non-ganirelix patients required twice daily blood monitoring in the peri-ovulatory period. Pregnancy outcomes were calculated and compared by Student’s t-test. Results: Comparison between the ganirelix and non-ganirelix groups showed no statistically significant difference with regard to age (mean = 37.9 years), lifetime peak FSH (mean = 10.8 IU/L), cycle start FSH (mean = 8.2 IU/L), number of prior failed IVF cycles (mean = 3.6), or presenting diagnosis. Pregnancy outcomes between the ganirelix and non-ganirelix groups (see table) were not significantly different. Comparative pregnancy outcomes in poor responders. legendlegendP > 0.05 for all groupings.CC/FSH/GanirelixCC/FSHPositive hCG27/78 (34.6%)53/177 (29.9%)Chemical Preg7/78 (9.0%)11/177 (6.2%)Missed SAB4/78 (5.1%)9/177 (5.1%)Ongoing Preg16/78 (20.5%)33/177 (18.6%)legend P > 0.05 for all groupings. Open table in a new tab Conclusions: Use of the GnRH antagonist, ganirelix, in poor responder IVF patients provides similar pregnancy outcomes to those seen with traditional clomiphene/FSH stimulation protocols. In addition, ganirelix permits more convenient cycle monitoring and control of oocyte retrieval scheduling. Previous concerns of decreased embryo implantation rates at higher GnRH antagonist dosing are not supported by the comparative pregnancy outcome results.