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CompletedNCT03249415Updated Mar 13, 2025

Use of PRP in Endometrial Reconstruction

An observational study in Asherman Syndrome and Endometrial Atrophy, sponsored by Fundación IVI. Completed at 1 site in Spain. Open to female participants aged 25 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-03-13.

Sponsored by Fundación IVI · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
10
Ages
25 Years to 40 Years
Sex
Female
01

Study summary

Infertility, which affected 48.5 million couples worldwide in 2010 alone, has many causes; some causes result from issues related to the endometrium. Unfortunately, no cure exists for medical conditions resulting in the destruction of the endometrium, or for non-functional uterus. Thus, safe and effective therapies are needed to treat these diseases and to establish fertility in affected women. These novel techniques refer to the use and application of regenerative/paracrine factors to regenerate the endometrium in patients with Asherman's Syndrome (AS) and Endometrial Atrophy (EA).These new therapies based on the injection of the identified regenerative/paracrine factors and the platelet-rich plasma (PRP) from whole blood in an immunodeficient mouse model with AS/EA, evaluating their contribution and/or effect in the endometrial repair by functional proofs.

Read the detailed description

The objective is to know the effect of these regenerative factors obtained from Platelet-Rich Plasma in an immunodeficient murine model with AS/EA Blood from patients with Asherman's Syndrome (AS) and Endometrial Atrophy (EA) will be collected, maintained under anticoagulant solution and after several centrifugations PRP will be obtained. Demonstration of a functional endometrium will be proved determining pregnancy and implantation rates as well as the number of live pups/pregnant female in our mice model. Also, the uterus histology will be analysed in treated and untreated mice

02

Conditions studied

  • Asherman Syndrome
  • Endometrial Atrophy

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Keywords

  • Platelet-Rich Plasma
  • Cell therapy
  • Regenerative factors
  • Autologous treatment
  • Paracrine factors
03

Who can participate

Ages eligible
25 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Participants diagnosed with Asherman Syndrome and Endometrial Atrophy by Hysteroscopy.

Inclusion criteria

  • Participants diagnosed with Asherman Syndrome and Endometrial Atrophy by Hysteroscopy.
  • No pregnancy after hormonal treatment.

Exclusion criteria

Exclusion Criteria:

  • Psychiatric diseases.
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
10 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
05

What researchers measure

Primary outcomes

  1. Endometrial thickness after reconstruction in murine model

    Using histological and functional technologies demonstration of regeneration ability of PRP

    Time frame: through study completion, an average of 1 year

06

Study locations

1 site
  • IVI Barcelona
    Barcelona, Spain
07

References and documents

Publications

  • Cervello I, Gil-Sanchis C, Santamaria X, Cabanillas S, Diaz A, Faus A, Pellicer A, Simon C. Human CD133(+) bone marrow-derived stem cells promote endometrial proliferation in a murine model of Asherman syndrome. Fertil Steril. 2015 Dec;104(6):1552-60.e1-3. doi: 10.1016/j.fertnstert.2015.08.032. Epub 2015 Sep 15. PubMed 26384164 ↗
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Registry details

Key details

Study ID
NCT03249415
Lead sponsor
Fundación IVI
Responsible party
Sponsor
First posted
Aug 15, 2017
Start date
Jul 18, 2017
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023
Last update
Mar 13, 2025

Study contacts

Irene Cervello, PhD
principal investigator · Fundación IVI
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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