Use of PRP in Endometrial Reconstruction

Asherman Syndrome Clinical Trial

Official title:

Endometrial Reconstruction by Human Regenerative Factors Derived From Platelet-Rich Plasma in Mice Models

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03249415
• Other study ID #: 1701-FIVI-003-IC
• Status: Recruiting
• Start date: July 18, 2017
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Fundación IVI
• Contact: Irene Cervello, PhD
• Phone: 0034963903305
• Email: Irene.Cervello[@]ivi.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 40 Years

Eligibility

Inclusion Criteria:

• Participants diagnosed with Asherman Syndrome and Endometrial Atrophy by Hysteroscopy.

• No pregnancy after hormonal treatment.

Exclusion Criteria:

• Psychiatric diseases.

Related Conditions & MeSH terms

• Asherman Syndrome
• Endometrial Atrophy

Locations

Country	Name	City	State
Spain	IVI Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundación IVI

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endometrial thickness after reconstruction in murine model	Using histological and functional technologies demonstration of regeneration ability of PRP	through study completion, an average of 1 year