Umbilical Cord Plasma for Treating Endometrial Pathologies (Thin Endometrium / Asherman's Syndrome/ Endometria Atrophy).

Who is this study for? Patients with Asherman Syndrome, Endometrial Atrophy
Status: Completed
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

In the last years, platelet-rich plasma (PRP) has emerged as a promising alternative to treat endometrial pathologies affecting the endometrial lining. Different studies have tried this therapeutic approach in human patient, but results are not conclusive at all. Also, in the last years, different studies have suggested the umbilical cord blood has a stronger reservoir of growth factors and other pro-regenerative molecules than the adult peripheral blood. That is the reason why the present study aims to evaluate if using platelet-rich plasma obtained from umbilical cord blood is able to increase endometrial thickness and prepare the endometrium for an embryo transference. However, due to the novelty of this approach, the investigators have considered to include a 'proof of concept' group (women with premature ovarian insufficiency) to obtain a deeper understanding of the clinical value of this blood derivative.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 48
Healthy Volunteers: f
View:

• Patient information sheet and signed informed consent.

• Female, acting voluntarily, aged between 18 and 48 years at the time of recruitment.

• BMI ≥ 18 kg/m2 and ≤ 35 kg/m2.

• Patients with premature ovarian failure (amenorrhea prior to 40 years of age and FSH \> 40 IU/L).

• Information and signed informed consent.

• female, acting voluntarily, aged between 18 and 48 years at the time of recruitment.

• body mass index (BMI): ≥ 18 kg/m2 and ≤ 35 kg/m2.

• Patients undergoing an assisted reproduction cycle.

• Endometrial thickness \< 5mm despite estrogen administration for more than 10 days and/or evidence of Asherman's Syndrome.

Locations
Other Locations
Spain
Hospital la Fe
Valencia
Time Frame
Start Date: 2022-04-22
Completion Date: 2025-01-27
Participants
Target number of participants: 15
Treatments
Other: Umbilical cord PRP donors
Women who are going to give birth to a healthy live newborn at the Hospital Universitario y Politécnico La Fe.~Donors will donate their umbilical cord blood to obtain the hUC-PRP. A total of 30±15 donors will be recruited.
Experimental: Group B- Asherman with PRP treatment and estrogen therapy
Women with thin endometrium/endometrial atrophy and/or Asherman's syndrome with fertility problems and reproductive desires, desires that could be achieved by their participation in the present study. A total of 15 patients will be included; all of them will receive the investigational treatment as well as estrogen therapy.
Other: Group A1- POI with PRP treatment and estrogen therapy
Women with premature ovarian failure (POI). A total of 10 patients will be included. All of them will receive the investigational treatment as well as estrogen therapy.
Other: Group A2- POI with estrogen therapy
Women with premature ovarian failure (POI). A total of 10 patients will be included. All of them will receive the estrogen therapy.
Other: Group A3- POI without PRP treatment nor estrogen therapy
Women with premature ovarian failure (POI). A total of 10 patients will be included. None of them will receive either the investigational treatment nor estrogen therapy.
Related Therapeutic Areas
Sponsors
Leads: Fundación IVI

This content was sourced from clinicaltrials.gov