The study is proposed to analyze the effect of three types of gonadotropin on embryo quality and kinetics of development in women undergoing an assisted reporduction treatment
Conditions
Interventions
Trade Name: Elonva
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: CORIFOLLITROPIN ALFA
CAS Number: 195962-23-3
Concentration unit: µg microgram(s)
Concentration typ
Sponsors
IVI Madrid
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Oocyte donors Vitrified oocytes Severe male factor (60 kg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Non-inferiority study of the type of gonadotropin used during a controlled ovarian stimulation protocol. To compare if the gonadotropin administered during ovarian stimulation affects timing of embryo divisions until 5 cell-stage;Secondary Objective: To prove if the dose of gonadotropin applied and the serum steroid levels the day of the triggering (estradiol and progesterone) affects embryo quality and development rate using time-lapse technology Comparative analysis of fertilization, pregnancy and implantation rates;Primary end point(s): T5 defined as the time that embryo needs to reach a 5-cell stage;Timepoint(s) of evaluation of this end point: In real time | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Length of stimulation (days) - Total dose of gonadotropins (IU) - Levels of FSH (IU) - Levels of estradiol (pg / ml) - Levels of progesterone (ng / ml) - Fertilization rate - Number of embryos transferred and cryopreserved - Pregnancy rate - Implantation rate - Miscarriage rate - Cancellation rate per cycle initiated - Ovarian hyperstimulation síndrome rate - Timings of cellular divisions;Timepoint(s) of evaluation of this end point: A month | — |
Countries
Spain
Contacts
Public ContactIVI Madrid
IVI Madrid
Outcome results
None listed