Infertility in patients requiring in vitro fertilization treatment with poor ovarian response profile, defined by Bologna Criteria. MedDRA version: 21.0 Level: PT Classification code 10021926 Term: Infertility System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Trade Name: ELONVA 150 microgramos solución inyectable
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CORIFOLLITROPIN ALFA
CAS Number:
Sponsors
Miguel Caballero Campo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Infertility requiring IVF/ICSI treatment b) Patients aged 36-41 c) Body weight = 50 kg d) Body Mass Index between 18.5 and 34.9 kg/m2 e) Menstrual cycles during previous four months lasting between 21 and 35 days f) At least two of the following three features present: - Previous poor ovarian reserve (less than 3 recovered oocytes) - Antral follicular count (AFC) lower than 7 and/or antiMüllerian hormone (AMH) less than 1.1 ng/mL - Any other risk factor for low ovarian response g) Signing of the informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 292 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a) Age, body weight, Body Mass Index or menstrual cycles duration out of inclusion range b) Extreme male factor, defined as severe oligozoospermia ( 11 mm measured by ultrasound examination - A basal antral follicle count > 20 - Fibroid tumours of the uterus incompatible with pregnancy - Malformations of the reproductive organs incompatible with pregnancy - Polycystic ovarian syndrome (PCOS) e) Contraindications for use of any other drug applied in this protocol f) Other uterine or tubal disorders that, in investigator's opinion, might cause relevant reduction of clinical pregancy and live birth rates
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate non-inferiority of a double ovarian stimulation using two sucessive doses of corifolltropin alfa (150 micrograms) versus two conventional controlled ovarian hyperstimulation cycles, in poor-responder patients defined according to Bologna Criteria, in terms of total number of oocytes obtained.; Secondary Objective: a) Evaluate non-inferiority of accumulative clinical pregnancy rate and live birth rate, as well as other secondary efficacy outcomes (duration of stimulation, total dose of gonafotropins, serum estradiol on HCG day, number of total and MII oocytes, number of fertilized oocytes, normal fertilization rate, number of cleaving embryos, number of total and top quality embryos, clinical pregnancy rate per randomized patient and per embryo transfer). b) Compare, with exploratory intention, safety, and tolerability outcomes as cancellation rate due to low or excessive response, oocyte atresia after ICSI, abnormal oocoye fertilization, total or partial fertilization failure, number of non-survival thawed embryos, number of post-thawed non-developing embryos, miscarriage after weeks of pregnancy, adverse reactions rate. b) Comparative cost-efectiveness analysis c) Comparative analysis of psyco-emotional effects of stimulation treatments ;Primary end point(s): Number of total retrieved oocytes; Timepoint(s) of evaluation of this end point: The main timepoint of evaluation will be embryo transfer phase of treatment. If embryo transfer is not reached as a result of any of the following causes, respective timepoints of evaluation will be: a) After cancelation of second stimulation, if this event occurs b) After second oocyte retrieval, if no oocytes are recovered c) After confirming absence of fertilization or abnormal fertilization in all recovered oocytes d) After confirming divisional | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Effectiveness secondary end points: - Duration of ovarian stimulation - Aditional gonadotropin consumption - Serum oestradiol on triptorelin/hCG day - Number of follicles > 15 mm and > 17 mm - Cancelation rate (due to insufficient ovarian response) - Number of metaphase II oocytes - Number of total and metaphase II oocytes obtained in first and second stimulation - Number of normally fertilized oocytes - Normal fertilization rate - Endometrial thickness on triptorelin/HCG administration day - Cumulative number of developing embryos grade A or B in +2 or +3 days, obtained from first stimulation - Cumulative number of developing embryos grade A or B in +2 or +3 days, obtained from second stimulation - Cumulative number of developing embryos grade C or D in +2 or +3 days, obtained from first stimulation - Cumulative number of developing embryos grade C or D in +2 or +3 days, obtained from second stimulation - Cumulative number of developing embryos grade A or B in +5 or +6 days, obtained from first stimulation - Cumulative number of developing embryos grade A or B in +5 or +6 days, obtained from second stimulation - Cumulative number of developing embryos grade C or D in +5 or +6 days, obtained from first stimulation - Cumulative number of developing embryos grade C or D in +5 or +6 days, obtained from second stimulation - Number of surviing embryos after devitrification - Endometrial thickness on cryotransfer scheduling - Implantation rate per fresh embryo transfer or freezed-thawed embryo transfer - Clinical pregnancy rate per fresh embryo transfer or freezed-thawed embryo tra | — |
Countries
Spain
Contacts
Public ContactSección de Reproducción Asistida
Hospital General Universitario Gregorio Marañón
Outcome results
None listed