Asherman SyndromeNCT03249415
Use of PRP in Endometrial Reconstruction
An observational study of Asherman Syndrome and Endometrial Atrophy, run by Fundación IVI at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Asherman Syndrome, Endometrial Atrophy
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 18 Jul 2017to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Participants diagnosed with Asherman Syndrome and Endometrial Atrophy by Hysteroscopy.
Who may be able to join
- Participants diagnosed with Asherman Syndrome and Endometrial Atrophy by Hysteroscopy.
- No pregnancy after hormonal treatment.
Who cannot join
- Psychiatric diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endometrial Reconstruction by Human Regenerative Factors Derived From Platelet-Rich Plasma in Mice Models
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
- Conditions
- Asherman Syndrome, Endometrial Atrophy
- Keywords
- Platelet-Rich Plasma, Cell therapy, Regenerative factors, Autologous treatment, Paracrine factors
- Medical subject headings
- Gynatresia
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial thickness after reconstruction in murine model
Using histological and functional technologies demonstration of regeneration ability of PRP
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start18 Jul 2017
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asherman SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación IVI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irene Cervello, PhD, Principal investigator, Fundación IVI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249415
- Sponsor's protocol ID
- 1701-FIVI-003-IC
- Status last verified
- Mar 2025
- First submitted
- 8 Jun 2017
- Last updated
- 13 Mar 2025
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Reconstruction by Human Regenerative Factors Derived From Platelet-Rich Plasma in Mice Models
- ClinicalTrials.gov ID
- NCT03249415
- Acronym / sponsor ID
- 1701-FIVI-003-IC
- Conditions
- Asherman Syndrome, Endometrial Atrophy
- Keywords
- Platelet-Rich Plasma, Cell therapy, Regenerative factors, Autologous treatment, Paracrine factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Fundación IVIUniversity, hospital or other
- Study start
- 18 Jul 2017 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 15 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants diagnosed with Asherman Syndrome and Endometrial Atrophy by Hysteroscopy.
Key inclusion criteria (2 listed)
- Participants diagnosed with Asherman Syndrome and Endometrial Atrophy by Hysteroscopy.
- No pregnancy after hormonal treatment.
Key exclusion criteria (1 listed)
- Psychiatric diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Endometrial thickness after reconstruction in murine model
Time frame: through study completion, an average of 1 year
Using histological and functional technologies demonstration of regeneration ability of PRP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Results publication: PubMed 26384164Cervello 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Cervello, PhD principal investigator
Fundación IVI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asherman Syndrome and Endometrial Atrophy, run by Fundación IVI at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometrial thickness after reconstruction in murine model (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03249415, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.