Clinical trial NCT03249415: Use of PRP in Endometrial Reconstruction
Official title: Endometrial Reconstruction by Human Regenerative Factors Derived From Platelet-Rich Plasma in Mice Models
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asherman Syndrome
Endometrial Atrophy
Keywords: Platelet-Rich Plasma
Cell therapy
Regenerative factors
Autologous treatment
Paracrine factors
Lead sponsor: Fundación IVI
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 10
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants diagnosed with Asherman Syndrome and Endometrial Atrophy by Hysteroscopy.

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Psychiatric diseases.

Primary outcomes:
measure: Endometrial thickness after reconstruction in murine model
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: IVI Barcelona
Study officials:
affiliation: Fundación IVI
name: Irene Cervello, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.