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NCT07697924
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)
Conditions: Asherman Syndrome
Sex: Female
Ages: 18 Years – 48 Years
Healthy volunteers: No
Phase: NA
Enrollment: 35
Sponsor: Fundación IVI
Location: IVI Valencia Valencia
Summary
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
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.
Source: ClinicalTrials.gov (NCT07697924). StuddyBuddy aggregates publicly available trial information.