Infertility
Conditions
Interventions
Product Name: FERTYPHARM TEST
Pharmaceutical Form: Anticoagulant and preservative solution for blood
INN or Proposed INN: FERTYPHARM TEST
Other descriptive name: FERTYPHARM TEST
Concentration unit: h
Sponsors
AB-BIOTICS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Normally ovulating infertile women, aged up to 38 years old • With BMI 18-28 • FSH values 0.7 ng/mL • Undergoing ovarian stimulation with exogenous gonadotropins in fresh IVF procedures (the protocol type indicated should be defined as short, combined (FSH and LH) with GnRH antagonists ) • Infertility cause: male infertility, tubal damage, and combinations of the aforementioned • Who has at least one COH cycle without BLcG positive and in which a standard protocol stimulation was used with combined Gonadotropins 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 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients who do not give their written informed consent to participate in the study • Patients who refuse to collect a blood sample, necessary for the obtaining of their genetic profile • Patients with an infertility cause other than tubal damage or male infertility (patients with pathological conditions potentially affecting their ovarian response, such premature ovarian failure, as endometriosis (at any stage) and polycystic ovarian syndrome)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to test the efficacy of a pharmacogenetics-driven approach, based on the information provided by the genetic polymorphism rs6166 in gene FSHR, to establish the doses of exogenous FSH (eFSH) in the COH protocols.;Secondary Objective: • Describe the frequency of the analyzed polymorphisms in the population included in the pre-treatment visit • Evaluate the discrepancies and similarities between the eFSH dosage recommendations according to the routine clinical measures and the genotype of the patient. • Study the association of the patient’s genotype with the quality of the response to the COH. • Study the association of the patient’s genotype with the IVF overall outcome (i.e. pregnancies and live births) • Evaluate the utility of using the pharmacogenetic information to select the eFSH dose, as perceived by the researchers. • Genotype other genetic markers that have been previously associated with response to COH .;Primary end point(s): To assess the efficacy of the pharmacogenetic-driven approach in the selection of the eFSH dose during the COH, the main variable will be the number of follicles on the rHCG application day.;Timepoint(s) of evaluation of this end point: The end of the study is defined as the last visit to the last recruited patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Frequency of polymorphisms, through genetic analysis results • COH quality, number of follicles > 17mm on the rHCG application day, number of mature retrieved oocytes, number of embryos and embryos quality in agreement of ASEBIR (Asociación para el Estudio de la Biología de la Reproducción) criteria [35] • IVF overall outcome, by measuring the implantation and pregnancy rates, and number of live births. Confirmation of pregnancy will be performed by measuring serum HCG (hormone chorionic gonadotropin) at least 15 days after embryo transfer (ET) and also the fetal heartbeat 6 weeks after ET. • Predictive algorithm.;Timepoint(s) of evaluation of this end point: The end of the study is defined as the last visit to the last recruited patient. | — |
Countries
Spain
Contacts
Public ContactClinical Trials Information
AB-BIOTICS
Outcome results
None listed