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

2001-FIVI-002-IC

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.

2022-04-22

2025-02-01

2025-03-01

Recruiting

Early phase I

45

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Recruitment period:\n\n* Umbilical cord donors: throughout the study. Although the aim is to recruit the maximum number of umbilical cord samples during the first 10±3 months of the study. 30±15 donors will be recruited.\n* Patients (group A and B): from month 4 of the first year until the end of the study.\n* Expected duration of treatment per patient:\n* Group A (arms 1 and 2): 22±8 days (visit 2 to visit 3).\n* Group B: 22±8 days (visit 2 to visit 3).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 45, 'type': 'ESTIMATED'}}

2024-02-28