infertility
Conditions
Brief summary
The primary efficacy endpoint is serum progesterone levels as well as P4/E2 ratio on the day of ovulation triggering. The primary efficacy endpoint is related to the primary trial objective.
Detailed description
Serum levels of estradiol, FSH, Testosterone and LH levels and P4/E2 ratio on days 1, 6, 8, 10 and the final day of oocyte maturation., Progesterone-to-follicle Index (PFI) on the day of ovulation triggering, Number of oocytes., Number of patients with optimal number of oocytes retrieved (≥10 oocytes)., Number of embryos., Good-quality embryos., Number of blastocysts., Clinical pregnancy defined as the presence of intrauterine gestational sac at 6-7 weeks of gestation., Ongoing pregnancy defined as the presence of intrauterine gestational sac with an embryonic pole demonstrating cardiac activity at 8-9 weeks of gestation.
Interventions
DRUGCrinone 8% gel vaginal
DRUGGONAL-f 900 IU/1.44 mL solution for injection in pre-filled pen
DRUGPergoveris (900 IU + 450 IU)/1.44 mL solution for injection in pre-filled pen
Sponsors
Santiago Dexeus Font Fundacio Privada
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is serum progesterone levels as well as P4/E2 ratio on the day of ovulation triggering. The primary efficacy endpoint is related to the primary trial objective. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum levels of estradiol, FSH, Testosterone and LH levels and P4/E2 ratio on days 1, 6, 8, 10 and the final day of oocyte maturation., Progesterone-to-follicle Index (PFI) on the day of ovulation triggering, Number of oocytes., Number of patients with optimal number of oocytes retrieved (≥10 oocytes)., Number of embryos., Good-quality embryos., Number of blastocysts., Clinical pregnancy defined as the presence of intrauterine gestational sac at 6-7 weeks of gestation., Ongoing pregnancy defined as the presence of intrauterine gestational sac with an embryonic pole demonstrating cardiac activity at 8-9 weeks of gestation. | — |
Countries
Spain
Outcome results
None listed