Umbilical Cord Plasma for Treating Endometrial Pathologies (Thin Endometrium / Asherman's Syndrome/ Endometria Atrophy) (hSCU-PRP)
Asherman Syndrome, Endometrial Atrophy
About this trial
This is an interventional treatment trial for Asherman Syndrome focused on measuring Endometrial pathology, Platelet-rich plasma, Umbilical cord blood, Regenerative medicine
Eligibility Criteria
UMBILICAL CORD DONORS
Donors of umbilical cord blood will be women (and their partners, if applicable) who give birth to a live newborn(s) in the Gynecology and Obstetrics service of HUP La Fe; the same umbilical cord collection criteria will be followed as standardized in HUP La Fe for the donation of this biological product.
GROUP A
Inclusion Criteria:
- 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).
Exclusion Criteria:
- Active genital infection proven at the time of recruitment; chronic endometritis.
- Known endometrial pathology.
- Psychological disorder that may hinder study follow-up.
- Positive results after viral safety analysis (HBsAg, HBcAb, HCV, HIV1, HIV2, syphilis).
- Presenting any syndrome or condition that, from the principal investigator's point of view, could pose a risk to the study or to the patient.
- Any significant clinical anomaly detected during the recruitment process; simultaneous participation in another clinical study that could affect the objectives of the present study or previous participation in this same study.
GROUP B
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Active genital infection proven at the time of recruitment; chronic endometritis.
- Known endometrial pathology.
- Psychological disorder that may hinder study follow-up.
- Positive results after viral safety analysis (HBsAg, HBcAb, HCV, HIV1, HIV2, syphilis).
- Presenting any syndrome or condition that, from the principal investigator's point of view, could pose a risk to the study or to the patient.
- Any significant clinical anomaly detected during the recruitment process; simultaneous participation in another clinical study that could affect the objectives of the present study or previous participation in this same study.
Sites / Locations
- Hospital la FeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Other
Experimental
Other
Other
Other
Umbilical cord PRP donors
Group B- Asherman with PRP treatment and estrogen therapy
Group A1- POI with PRP treatment and estrogen therapy
Group A2- POI with estrogen therapy
Group A3- POI without PRP treatment nor estrogen therapy
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.
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.
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.
Women with premature ovarian failure (POI). A total of 10 patients will be included. All of them will receive the 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.