
Is late follicular phase stimulation as efficient as early follicular phase stimulation in a gonadotrophin-releasing hormone (GnRH) antagonist protocol in oocyte donors in terms of the number of oocytes.In this open label, phase 3, non-inferiority, randomized controlled trial using a two-arm design with a 1:1 allocation ratio, 84 oocyte donors were allocated to the early follicular start group (control group, n = 41) or the late follicular start group (study group, n = 43). In the control group, women followed a fixed GnRH antagonist protocol with recombinant FSH (r-FSH) 225 IU. In the study group, r-FSH 225 IU was initiated in the late follicular phase. The primary outcome was the number of oocytes. The secondary outcomes were the number of mature oocytes, consumption of gonadotrophins and GnRH antagonist, and cost of medication.The number of oocytes did not differ between the control group and the study group (intent-to-treat analysis 15.5 ± 11.0 versus 14.0 ± 10.7, P = 0.52; per-protocol analysis 18.2 ± 9.7 versus 18.8 ± 7.8, P = 0.62). In addition, the number of mature oocytes did not differ between the groups (14.1 ± 8.1 versus 12.7 ± 8.5, P = 0.48). The duration of stimulation was shorter in the control group (10.0 ± 1.4 versus 10.9 ± 1.5 days, P = 0.01). The total amount of r-FSH used was lower in the control group (2240.7 ± 313.9 IU versus 2453.9 ± 330.1 IU, P = 0.008). A GnRH antagonist was used for approximately 6 days in the control group, while a GnRH antagonist was only prescribed for one woman in the study group (6.0 ± 1.4 days versus 0.13±0.7 days, P < 0.001). There was a significant difference in the cost of medication per cycle between the groups (1147.9 ± 182.8€ in control group versus 979.9 ± 129.0€ in study group, P < 0.001).Late follicular phase stimulation is as efficient as early follicular phase stimulation in terms of the number of oocytes.
Pregnancy Rate, clinical outcome, Oocyte Retrieval, luteinizing hormone release, Chorionic Gonadotropin, ovarian reserve, Gonadotropin-Releasing Hormone, gonadotropin blood level, follitropin blood level, Pregnancy, Estradiol, non-inferiority trial, Oocyte Donation, oocyte donor, article, recombinant follitropin, oocyte number, transvaginal echography, per protocol analysis, ovarian stimulation, NCT03767218, Intention to Treat Analysis, Follicular Phase, oocyte donation, Randomized Controlled Trial, Female, follitropin, Art, ANTRAL FOLLICLE COUNT, Human, Adult, drug cost, progesterone, menstrual cycle, open study, ovary hyperstimulation, Hormone Antagonists, Ovulation Induction, Humans, treatment duration, phase 3 clinical trial, triptorelin, Luteinizing Hormone, progesterone blood level, major clinical study, oocyte maturation, ganirelix, estradiol blood level, Oocytes, luteinizing hormone blood level, Follicle Stimulating Hormone, Controlled study
Pregnancy Rate, clinical outcome, Oocyte Retrieval, luteinizing hormone release, Chorionic Gonadotropin, ovarian reserve, Gonadotropin-Releasing Hormone, gonadotropin blood level, follitropin blood level, Pregnancy, Estradiol, non-inferiority trial, Oocyte Donation, oocyte donor, article, recombinant follitropin, oocyte number, transvaginal echography, per protocol analysis, ovarian stimulation, NCT03767218, Intention to Treat Analysis, Follicular Phase, oocyte donation, Randomized Controlled Trial, Female, follitropin, Art, ANTRAL FOLLICLE COUNT, Human, Adult, drug cost, progesterone, menstrual cycle, open study, ovary hyperstimulation, Hormone Antagonists, Ovulation Induction, Humans, treatment duration, phase 3 clinical trial, triptorelin, Luteinizing Hormone, progesterone blood level, major clinical study, oocyte maturation, ganirelix, estradiol blood level, Oocytes, luteinizing hormone blood level, Follicle Stimulating Hormone, Controlled study
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