Endometrial pathologies (Thin endometrium/ Asherman's syndrome/ Endometrial atrophy)
Conditions
Interventions
Product Name: Platelet-rich plasma from umbilical cord.
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: platelet rich plasma, allogenic
Other descriptive name: HUMAN PLATELET
Sponsors
IVI Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Umbilical cord blood donors: information and informed consent of the parent(s), umbilical cord blood from live births in the obstetrics and gynaecology department of the HUP La Fe; the same criteria for collecting umbilical cord blood as standardised in the HUP La Fe will be followed for the donation of this biological product. Patients group A: information and signed informed consent; woman, acting voluntarily, aged between 18 and 48 at the time of recruitment; body mass index (BMI): = 18 kg/m2 and = 35 kg/m2; patients with premature ovarian failure (amenorrhea before age 40 and FSH > 40 IU/L). Group B patients: information and signed informed consent; female, acting voluntarily, aged between 18 and 48 years at the time of recruitment; body mass index (BMI): = 18 kg/m2 and = 35 kg/m2; patients undergoing a cycle of assisted reproduction; endometrial thickness =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Umbilical cord blood donors: the same criteria for collecting umbilical cord blood as standardised in the HUP La Fe will be followed for the donation of this biological product. The exclusion criteria will be the same for patient groups A and B: active genital infection proven at the time of recruitment; chronic endometritis; known endometrial pathology; psychological disorder that may make it difficult to follow up the study; positive results after serological analysis (HBsAg, HBcAb, HCV, HIV1, HIV2, syphilis); presenting any syndrome or condition that, in the view of the principal investigator, could pose a risk to the study or to the patient; any significant clinical abnormality detected during the recruitment process; simultaneous participation in another study. The study will be carried out in the context of a clinical trial that may affect the objectives of the present study or after participation in the same study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Study of endometrial regeneration and/or improvement, in the form of tissue thickening, in patients with endometrial pathologies (thin endometrium/Asherman's syndrome/endometrial atrophy) treated with platelet-rich plasma from the umbilical cord.;Secondary Objective: Evaluation of the proof of concept in the 3 arms of the group of patients with premature ovarian failure (group A). Study of the rates of implantation, pregnancy, abortion and live newborn after injection of the investigational drug (platelet-rich plasma from umbilical cord) in the group of patients with endometrial pathology (group B). Evaluation at the genetic and protein level of the endometrial biopsies collected from both groups (A and B). Study of the molecular composition of the different plasma fractions obtained from the collected umbilical cord samples Adverse events collection;Primary end point(s): Increase in endometrial thickness after application of PRP treatment, calculated as the difference between the endometrium after application of the treatment and the thickness of the patient's initial endometrium (in mm);Timepoint(s) of evaluation of this end point: After application of PRP treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proof of concept. Implementation rate. Pregnancy rate. Abortion rate. Live birth rate. Evaluation at the genetic and protein level of the endometrial biopsies collected from both groups (A and B). Study of the molecular composition of the different plasma fractions obtained from the collected umbilical cord samples Adverse events collection;Timepoint(s) of evaluation of this end point: Proof of concept._Comparisons of endometrial thickness growth before and after PRP treatment, according to subgroups (grupo A) at the end of study Study of the rates of implantation, pregnancy, abortion and live newborn after injection of the investigational drug (platelet-rich plasma from umbilical cord) in the group of patients with endometrial pathology (group B), will be analized at the end of the study. Composition molecular of the plasma fractions of the PRP samples of the umbilical cord used, Protein and genetic pattern of the collected endometrial biopsies before and after applying the PRP treatment, will be analysed at the end of the study. Adverse effects, during all study. | — |
Countries
Spain
Contacts
Public ContactDavinia Oltra Noguera
IVI Foundation
Outcome results
None listed