Asherman Syndrome
Conditions
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.
Interventions
OTHERUmbilical cord platelet-rich plasma (hUC-PRP)
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.
Sponsors
Fundación IVI
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 48 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 8 weeks | If more than one endometrial thickness measurement is recorded, the average of the measurements will be calculated. |
Countries
Spain
Outcome results
None listed