mbilical cord plasma for treating endometrial pathologies (thin endometrium / Ash erman’s syndrome/ endometria atrophy)

Phase 1

• Conditions: Endometrial pathologies (Thin endometrium/ Asherman's syndrome/ Endometrial atrophy); Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2020-005717-40-ES
• Lead Sponsor: IVI Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-09
• Last Update Posted: 10 May 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

Umbilical cord blood donors: information and informed consent of the parent(s), umbilical cord blood from live births in the obstetrics and gynaecology department of the HUP La Fe; the same criteria for collecting umbilical cord blood as standardised in the HUP La Fe will be followed for the donation of this biological product.
Patients group A: information and signed informed consent; woman, acting voluntarily, aged between 18 and 48 at the time of recruitment; body mass index (BMI): = 18 kg/m2 and = 35 kg/m2; patients with premature ovarian failure (amenorrhea before age 40 and FSH > 40 IU/L).
Group B patients: 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 a cycle of assisted reproduction; endometrial thickness < 5mm despite the administration of oestrogens for more than 10 days and/or evidence of Asherman's Syndrome.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Umbilical cord blood donors: the same criteria for collecting umbilical cord blood as standardised in the HUP La Fe will be followed for the donation of this biological product.
The exclusion criteria will be the same for patient groups A and B: active genital infection proven at the time of recruitment; chronic endometritis; known endometrial pathology; psychological disorder that may make it difficult to follow up the study; positive results after serological analysis (HBsAg, HBcAb, HCV, HIV1, HIV2, syphilis); presenting any syndrome or condition that, in the view of the principal investigator, could pose a risk to the study or to the patient; any significant clinical abnormality detected during the recruitment process; simultaneous participation in another study.
The study will be carried out in the context of a clinical trial that may affect the objectives of the present study or after participation in the same study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified