CURENDO (Cord-blood Uterine Regeneration Endometrium): Platelet-rich Plasma Therapy Derived From Umbilical Cord Blood for the Treatment of Endometrial Pathologies (Asherman Syndrome / Endometrial Atrophy / Thin Endometrium)

Fundación IVI35 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Asherman Syndrome

Interventions

Umbilical 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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 48 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * Active genital infection at the time of recruitment * chronic endometritis * known endometrial pathology * psychiatric disorder that could hinder study follow-up * positive results on viral safety testing (HBsAg, HBcAb, HCV, HIV-1, HIV-2, syphilis) * presence of any syndrome or condition that, in the opinion of the principal investigator, could pose a risk to the study or to the patient * any clinically significant abnormality detected during the recruitment process * simultaneous participation in another clinical study that could affect the objectives of the present study, or prior participation in this same study.

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.

Time frame: 8 weeks