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)

NCT07697924 | Recruiting DMC

• 1 other identifier: 2411-FIVI-218-IC
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asherman Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Interventions

Umbilical cord platelet-rich plasma (hUC-PRP) OTHER

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 Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación IVI: lead

Study Sites (1)

IVI Valencia

Valencia, Spain

RECRUITING

MeSH Terms

Conditions

Gynatresia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 13, 2026
• Study Start: December 18, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 13, 2026

Record last verified: 2026-06

Locations

ES (1)