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)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-48
SponsorFundación IVI

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

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

    Other intervention

    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.

Treatment groups

No treatment groups listed

Trial outcomes

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.

Time frame
8 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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