About this trial
In recent years, platelet-rich plasma (PRP) has emerged as a promising alternative for treating endometrial pathologies that affect the endometrial lining. Several studies have tested this therapeutic approach in human patients, but the results are inconclusive. Moreover, in recent years, different investigations have suggested that PRP derived from umbilical cord blood (hUC-PRP) contains a higher concentration of growth factors and other pro-regenerative molecules than PRP obtained from adult peripheral blood. In our previous pilot study conducted in 15 patients with endometrial atrophy/Asherman syndrome/thin endometrium, preliminary results indicate that hysteroscopic injection of hUC-PRP increases endometrial thickness and improves the endometrial pattern. For this reason, the present study aims to corroborate our previous findings by increasing the number of patients to 35, in prior HRT cycles in these women, to gain a deeper understanding of the effectiveness of this new therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age between 18 and 48 years at the time of recruitment
body mass index (BMI): ≥ 18 kg/m2 and ≤ 35 kg/m2
endometrial thickness < 5 mm despite estrogen administration according to each clinic's routine practice for 10 or more days and/or evidence of Asherman syndrome.
Disqualifiers
Active genital infection at the time of recruitment
chronic endometritis
known endometrial pathology
psychiatric disorder that could hinder study follow-up
Trial design
Single group
Treatments tested in this trial
Umbilical cord platelet-rich plasma (hUC-PRP)
Other interventionUmbilical cord platelet-rich plasma (hUC-PRP) obtained from samples sourced from a cord blood bank, which will be activated with 5% CaCl₂ prior to injection into the subendometrial wall of the uterine cavity via hysteroscopy. All patients will receive a single administration of allogeneic hUC-PRP after 10±2 days of estrogen treatment during the treatment phase.
Treatment groups
Trial outcomes
Primary outcomes
Increase in endometrial thickness following treatment with hUC-PRP, calculated as the difference between the endometrial thickness after treatment and the patient's initial endometrial thickness (mm).
If more than one endometrial thickness measurement is recorded, the average of the measurements will be calculated.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.