NCT03249415

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

July 18, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 15, 2017

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

6.5 years

First QC Date

June 8, 2017

Last Update Submit

March 11, 2025

Conditions

Keywords

Platelet-Rich PlasmaCell therapyRegenerative factorsAutologous treatmentParacrine factors

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age25 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipant with endometrial pathologies.
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Participants diagnosed with Asherman Syndrome and Endometrial Atrophy by Hysteroscopy.

You may qualify if:

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

You may not qualify if:

  • Psychiatric diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVI Barcelona

Barcelona, Spain

Location

Related 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. doi: 10.1016/j.fertnstert.2015.08.032. Epub 2015 Sep 15.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Platelet-Rich Plasma from Whole Blood.

MeSH Terms

Conditions

Gynatresia

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Irene Cervello, PhD

    Fundación IVI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2017

First Posted

August 15, 2017

Study Start

July 18, 2017

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

March 13, 2025

Record last verified: 2025-03

Locations