infertile women MedDRA version: 20.0 Level: PT Classification code 10056204 Term: In vitro fertilisation System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: LLT Classification code 10016463 Term: Fertility decreased female System Organ Class: 100000024038 MedDRA version: 20.0 Level: PT Classification code 10021928 Term: Infertility female System Organ Class: 10038604 - Reproductive system and breast disorders MedDRA version: 20.0 Level: PT Classificati
Conditions
Interventions
Product Name: PRP (Obtenido por PRGF-Endoret)
Pharmaceutical Form: Blood fraction modifier
INN or Proposed INN: Platelet Rich Plasma
Other descriptive name: AUTOLOGOUS PLASMA
Concentration unit: ml mi
Sponsors
Sara Rafael Fernández
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Women who signed informed consent. ? Women who understand the Spanish language. 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 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Thrombopenia. ? Coagulation problems. Congenital or acquired uterine malformations that reduce embryo implantation or term gestation. Ovarian tumors. Benign uterine tumors require surgical treatment ? Local acute inflammatory diseases ? Patients with malignant tumors requiring chemotherapy. ? Patients with acute or chronic infectious or inflammatory diseases requiring active treatment with drugs that may interfere with implantation and gestation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine the percentage of women who achieve an endometrial thickness equal to or greater than 7 mm after administration of PRGF;Secondary Objective: Determine the endometrial thickness after intrauterine administration of autologous platelet concentrate. Analyze the incidence of biochemical pregnancy Analyze the percentage of women who achieve clinical gestation. Evaluate the safety of PRGF administration. Determine the number of newborn Determine the number of abortions. Determine the number of registered ectopic pregnancies. Determine the number of women requiring administration of a second dose of PRGF. To compare the number of pregnancies among women who received a dose of PRGF compared to those who received two doses;Primary end point(s): Percentage of women who achieve an endometrial thickness equal to or greater than 7 mm;Timepoint(s) of evaluation of this end point: 3 days after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Thrombopenia. ? Coagulation problems. Congenital or acquired uterine malformations that reduce embryo implantation or term gestation. Ovarian tumors. Benign uterine tumors require surgical treatment ? Local acute inflammatory diseases ? Patients with malignant tumors requiring chemotherapy. ? Patients with acute or chronic infectious or inflammatory diseases requiring active treatment with drugs that may interfere with implantation and gestation.;Timepoint(s) of evaluation of this end point: 3 days after the treatment 14 days after the treatment Labour | — |
Countries
Spain
Contacts
Public ContactSponsor
Sara Rafael Fernández
Outcome results
None listed