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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03249415
Other study ID # 1701-FIVI-003-IC
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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