Impact of Mid-Luteal Phase GnRH Agonist Administration on Reproductive Outcomes in GnRH Agonist-Triggered Cycles: A Randomized Controlled Trial

Abstract

ObjectiveTo explore whether the addition of a mid-luteal bolus of GnRH agonist (GnRHa) improves the implantation rate (IR) in in vitro fertilization (IVF) cycles.DesignA randomized controlled trial.SettingPrivate IVF center.Patients328 IVF/intracytoplasmic sperm injection patients were triggered with GnRHa and received 1,500 IU HCG on the day of oocyte pick-up (OPU) in addition to a standard luteal phase support (LPS).Intervention(s)In addition, the study group received a bolus of GnRHa 6 days after OPU, whereas the control group did not.Main outcome measureImplantation rate.Secondary outcome measure(s)Ongoing pregnancy (OP) and live birth (LB) rates.ResultsAlthough serum concentrations of FSH, LH, E2, and P on day OPU + 7 were significantly higher in the study group compared to the control group, the IR was not statistically different between the treatment group (27%) and the control group (23%) [odds ratio (OR) 1.2 (95% CI 0.9–1.7), P < 0.27]. Similarly, the OP rate was 37% in the treatment group and 31% in the control group [OR 1.3 (95% CI 0.8–2.0), P < 0.23]. The LB rate was 36% in the treatment group and 31% in the control group [OR: 1.3 (95% CI 0.8–2.0), P < 0.27].ConclusionAlthough a trend toward a higher IR and pregnancy rate was observed in the treatment group, this difference was not statistically significant. However, the absolute risk difference of 5% found for LB is clinically relevant, warranting further investigation.NCT02053779.

Administration effects of single‑dose GnRH agonist for luteal support in females undertaking IVF/ICSI cycles: A meta‑analysis of randomized controlled trials

“…On the other hand, in the subgroup of trials where the GnRH-A ovarian stimulation protocol was used, the CPR per transfer was significantly superior in the GnRHa group (41.38%; 180/435) than in the control group (31.11%; 149/479; P=0.040; RR=1.32, 95% CI=0.96-1.81; Fig. 4) (19,21,23,25,26).…”

“…As above, a sensitivity analysis excluding the study by Ata and Urman (23) was performed (Fig. 5), and the pooled CPR per transfer was significantly higher in the GnRHa group (41.95%; 425/1,013) than that in the control group (32.92%; 342/1,039; P=0.001; RR=1.34, 95% CI=1.12-1.59) (19)(20)(21)(22)(24)(25)(26). This trend was more evident with the GnRH-A ovarian stimulation protocol (P<0.0001; RR=1.45, 95% CI=1.20-1.74) (19,21,25,26).…”

“…In addition, 38 articles that did not meet the inclusion criteria were excluded. Finally, among the 20 potentially relevant studies were obtained and a total of 8 studies fulfilled the inclusion criteria (19)(20)(21)(22)(23)(24)(25)(26). A flowchart depicting the selection process is provided in Fig.…”

“…In three studies (20,22,24), the long GnRH-a ovarian treatment protocol starting in the mid-luteal phase of the preceding cycle was used, in four studies (21,23,25,26), the GnRH-A multi low-dose ovarian treatment protocol was applied and in one study (19), both ovarian treatment protocol types were used. The trials published by Tesarik et al (8) used both the GnRH-a and the GnRH-A treatment protocol.…”

Bureaucratic overheating is a parasite hampering modern clinical research – a viewpoint from the ‘belly of the beast’

“…The first signs and symptoms of the bureaucratic overload can already be seen. More and more ground-breaking clinical research is now conducted outside Europe and North America, quite often with the participation of European and American co-ordinators -typically in East Asia -not only due to a higher patient flow, but also due to faster, more focused and more efficient regulatory processes (Benmachiche et al, 2017;Vuong et al, 2016). Thus, outsourcing is not just an industrial issue, and several of these clinical research projects have already been published in high-impact international journals (Chen et al, 2016;Shi et al, 2018;Vuong et al, 2018).…”