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Abstract
BackgroundNo previous study directly compares the fixed day-5 initiation versus the flexible initiation of GnRH antagonist administration in IVF/ICSI for those patients who are predicted as high ovarian responders without PCOS. To evaluate whether the number of oocytes retrieved is different by using the two GnRH antagonist protocols in Chinese women with predicted high ovarian response except PCOS.MethodsA randomized controlled trial of 201 infertile women with predicted high ovarian response except PCOS undergoing in vitro fertilization. Ovary stimulation was performed using recombinant FSH and GnRH antagonists. GnRH antagonist ganirelix (0.25 mg/d) was started either on day 5 of stimulation (fixed group) or when LH was > 10 IU/L, and/or a follicle with mean diameter > 12 mm was present, and/or serum E2 was > 600 pg/ml. Patient monitoring was initiated on day 3 of stimulation in flexible group.Result(s)No significant difference was observed between the fixed and flexible groups regarding the number of oocytes retrieved (16.72 ± 7.25 vs. 17.47 ± 5.88, P = 0.421), the Gonadotropin treatment duration (9.53 ± 1.07 vs. 9.67 ± 1.03, P = 0.346) and total Gonadotropin dose (1427.75 ± 210.6 vs. 1455.94 ± 243.44, P = 0.381). GnRH antagonist treatment duration in fixed protocol was statistically longer than the flexible protocol (6.57 ± 1.17 vs 6.04 ± 1.03, P = 0.001). There was no premature LH surge in either protocol.Conclusion(s)Fixed GnRH antagonist administration on day 5 of stimulation appear to achieve a comparable oocyte retrieved compared with flexible antagonist administration.Trial registrationNCT02635607 posted on December 16, 2015 in clinicaltrials.gov.
Highlights
No previous study directly compares the fixed day-5 initiation versus the flexible initiation of Gonadotrophin-releasing hormone (GnRH) antagonist administration in IVF/Intra-cytoplasmic sperm injection (ICSI) for those patients who are predicted as high ovarian responders without polycystic ovarian syndrome (PCOS)
One hundred patients in fixed protocol group and 101 patients in the flexible protocol group were adhere to the ovarian stimulation protocol
Flexible group (n = 101) 9.7 ± 1.0 1455.9 ± 243.4 6.0 ± 1.0 2. This was the first randomized control trial to compare the clinical outcome of the fixed GnRH antagonist protocol with the flexible protocol in IVF/ICSI for the patients with predicted high ovary response except PCOS, we found no difference in total number of oocytes retrieved in the fixed protocol compared with the flexible protocol
Summary
No previous study directly compares the fixed day-5 initiation versus the flexible initiation of GnRH antagonist administration in IVF/ICSI for those patients who are predicted as high ovarian responders without PCOS. As to the effectiveness of protocol, in a meta-analysis of four randomized controlled trials (RCTs), the fixed and flexible GnRH antagonist protocols have been found comparable in terms of the number of oocytes retrieved and clinical pregnancy rates, mainly for ovulate women with normal ovarian reserve [3,4,5,6,7]. For patients with high ovarian response, only one RCT including 100 infertile women with polycystic ovarian syndrome (PCOS) showed that the number of oocytes retrieved and good quality embryos in the flexible protocol were more than those in the fixed protocol with similar antagonist dose and less rFSH dose [8]
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