Umbilical Cord Plasma for Treating Endometrial Pathologies (Thin Endometrium / Asherman's Syndrome/ Endometria Atrophy)

PHASE2CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

April 22, 2022

Primary Completion Date

January 27, 2025

Study Completion Date

January 27, 2025

Conditions
Asherman SyndromeEndometrial Atrophy
Interventions
PROCEDURE

Injection of hUC-PRP by hysteroscopy

PRP previously frozen at -80ºC (6±2 mL) will be defrozen after checking donor-receptor compatibility and viral safety study. PRP (4±2 mL) will be activated with 5% CaCl2 and immediately injected (4±2 mL) in the sub-endometrial wall via hysteroscopy.

DRUG

Oestraclin

Patients will receive estrogenic therapy, based on estradiol, for 10±2 days (oestraclin, topical cream, 5µg daily for 10±2 days).

PROCEDURE

Umbilical cord blood collection

The SCU will be collected using a blood collection bag containing anticoagulant. This step will be performed by the medical and nursing staff of the obstetrics service of the HUP La Fe. The blood collection bags will be the following, or similar: Cord Blood Collection Bags from MACOPHARMA; CPD Umbilical Cord Bag from GRIFOLS.

PROCEDURE

Endometrial biopsy

Biopsies will be taken by specialized medical personnel by aspiration with an intrauterine cannula (pipelle or cornier). Samples will be collected in 15 mL tubes (or in a larger capacity container if needed) containing PBS or RNA later until frozen at -80ºC, at the IVI Foundation facilities. Prior to freezing (in a 1.8-2 mL cryotube) the PBS will be removed and the sample cleaned in a Petri dish if needed.

Trial Locations (1)

46026

Hospital la Fe, Valencia

All Listed Sponsors
lead

Fundación IVI

OTHER