Asherman SyndromePhase 2hSCU-PRPNCT05095597
Umbilical Cord Plasma for Treating Endometrial Pathologies (Thin Endometrium / Asherman's Syndrome/ Endometria Atrophy)
A Phase 2 study testing Injection of hUC-PRP by hysteroscopy, Oestraclin and Umbilical cord blood collection in people with Asherman Syndrome and Endometrial Atrophy, run by Fundación IVI at 1 site in Spain.
Trial summary
In the last years, platelet-rich plasma (PRP) has emerged as a promising alternative to treat endometrial pathologies affecting the endometrial lining. Different studies have tried this therapeutic approach in human patient, but results are not conclusive at all. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Asherman Syndrome, Endometrial Atrophy
- What is being tested?
- Injection of hUC-PRP by hysteroscopy, Oestraclin and Umbilical cord blood collection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 22 Apr 2022to 27 Jan 2025
- Phase
- Phase 2
- 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 18 to 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patient information sheet and signed informed consent.
- Female, acting voluntarily, aged between 18 and 48 years at the time of recruitment.
- BMI ≥ 18 kg/m2 and ≤ 35 kg/m2.
- Patients with premature ovarian failure (amenorrhea prior to 40 years of age and FSH > 40 IU/L).
- Information and signed informed consent.
- female, acting voluntarily, aged between 18 and 48 years at the time of recruitment.
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- body mass index (BMI): ≥ 18 kg/m2 and ≤ 35 kg/m2.
- Patients undergoing an assisted reproduction cycle.
- Endometrial thickness < 5mm despite estrogen administration for more than 10 days and/or evidence of Asherman's Syndrome.
Who cannot join
- Active genital infection proven at the time of recruitment; chronic endometritis.
- Known endometrial pathology.
- Psychological disorder that may hinder study follow-up.
- Positive results after viral safety analysis (HBsAg, HBcAb, HCV, HIV1, HIV2, syphilis).
- Presenting any syndrome or condition that, from the principal investigator's point of view, could pose a risk to the study or to the patient.
- Any significant clinical anomaly detected during the recruitment process; simultaneous participation in another clinical study that could affect the objectives of the present study or previous participation in this same study.
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- GROUP B
- Active genital infection proven at the time of recruitment; chronic endometritis.
- Known endometrial pathology.
- Psychological disorder that may hinder study follow-up.
- Positive results after viral safety analysis (HBsAg, HBcAb, HCV, HIV1, HIV2, syphilis).
- Presenting any syndrome or condition that, from the principal investigator's point of view, could pose a risk to the study or to the patient.
- Any significant clinical anomaly detected during the recruitment process; simultaneous participation in another clinical study that could affect the objectives of the present study or previous participation in this same study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Umbilical Cord Plasma for Treating Endometrial Pathologies (Thin Endometrium / Asherman's Syndrome/ Endometria Atrophy).
In the last years, platelet-rich plasma (PRP) has emerged as a promising alternative to treat endometrial pathologies affecting the endometrial lining. Different studies have tried this therapeutic approach in human patient, but results are not conclusive at all. Also, in the last years, different studies have suggested the umbilical cord blood has a stronger reservoir of growth factors and other pro-regenerative molecules than the adult peripheral blood. That is the reason why the present study aims to evaluate if using platelet-rich plasma obtained from umbilical cord blood is able to increase endometrial thickness and prepare the endometrium for an embryo transference. However, due to the novelty of this approach, the investigators have considered to include a 'proof of concept' group (women with premature ovarian insufficiency) to obtain a deeper understanding of the clinical value of this blood derivative.
Read the detailed description
Phase II clinical trial, designed as a pilot study, single-center and open-label, which aims to study the efficacy of platelet-rich plasma from umbilical cord after injection into a pathological endometrium (thin endometrium, Asherman's Syndrome, endometrial atrophy).
This treatment will be applied to patients with the aforementioned endometrial pathologies (group B), as well as to patients with premature ovarian failure (group A), which will serve to study its clinical value in greater detail. Plasma samples as well as endometrial biopsies will be analyzed to try to understand what molecular events are triggered in the endometrial tissue after the application of the treatment under study.
- Conditions
- Asherman Syndrome, Endometrial Atrophy
- Being tested
- Injection of hUC-PRP by hysteroscopy, Oestraclin, Umbilical cord blood collection, Endometrial biopsy
- Keywords
- Endometrial pathology, Platelet-rich plasma, Umbilical cord blood, Regenerative medicine
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of hUC-PRP by hysteroscopyProcedure or surgery
PRP previously frozen at -80ºC (6±2 mL) will be defrozen after checking donor-receptor compatibility and viral safety study. PRP (4±2 mL) will be activated with 5% CaCl2 and immediately injected (4±2 mL) in the sub-endometrial wall via hysteroscopy.
OestraclinDrug
Patients will receive estrogenic therapy, based on estradiol, for 10±2 days (oestraclin, topical cream, 5µg daily for 10±2 days).
Umbilical cord blood collectionProcedure or surgery
The SCU will be collected using a blood collection bag containing anticoagulant. This step will be performed by the medical and nursing staff of the obstetrics service of the HUP La Fe. The blood collection bags will be the following, or similar: Cord Blood Collection Bags from MACOPHARMA; CPD Umbilical Cord Bag from GRIFOLS.
Endometrial biopsyProcedure or surgery
Biopsies will be taken by specialized medical personnel by aspiration with an intrauterine cannula (pipelle or cornier). Samples will be collected in 15 mL tubes (or in a larger capacity container if needed) containing PBS or RNA later until frozen at -80ºC, at the IVI Foundation facilities. Prior to freezing (in a 1.8-2 mL cryotube) the PBS will be removed and the sample cleaned in a Petri dish if needed.
| Study group | Role | What they receive |
|---|---|---|
| Umbilical cord PRP donors | Other | Women who are going to give birth to a healthy live newborn at the Hospital Universitario y Politécnico La Fe.
Donors will donate their umbilical cord blood to obtain the hUC-PRP. A total of 30±15 donors will be recruited. Receives: Procedure: Umbilical cord blood collection |
| Group B- Asherman with PRP treatment and estrogen therapy | Experimental | Women with thin endometrium/endometrial atrophy and/or Asherman's syndrome with fertility problems and reproductive desires, desires that could be achieved by their participation in the present study. A total of 15 patients will be included; all of them will receive the investigational treatment as well as estrogen therapy. Receives: Procedure: Injection of hUC-PRP by hysteroscopy; Drug: Oestraclin; Procedure: Endometrial biopsy |
| Group A1- POI with PRP treatment and estrogen therapy | Other | Women with premature ovarian failure (POI). A total of 10 patients will be included. All of them will receive the investigational treatment as well as estrogen therapy. Receives: Procedure: Injection of hUC-PRP by hysteroscopy; Drug: Oestraclin; Procedure: Endometrial biopsy |
| Group A2- POI with estrogen therapy | Other | Women with premature ovarian failure (POI). A total of 10 patients will be included. All of them will receive the estrogen therapy. Receives: Drug: Oestraclin; Procedure: Endometrial biopsy |
| Group A3- POI without PRP treatment nor estrogen therapy | Other | Women with premature ovarian failure (POI). A total of 10 patients will be included. None of them will receive either the investigational treatment nor estrogen therapy. Receives: Procedure: Endometrial biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of endometrial regeneration and/or improvement in patients with endometrial pathologies (thin endometrium/Asherman's syndrome/endometrial atrophy) treated with platelet-rich plasma from the umbilical cord by endometrial thickeness.
Improvement will be studied in form of tissue thickening (mm), comparing endometrial thickness before and after PRP injection
Measured: An average of 3 months
Secondary outcomes (3)
Proof-of-concept in POI patients by improvement endometrial thickeness.
Improvement will be studied in form of tissue thickening (mm), comparing endometrial thickness before and after PRP injection.
Measured: An average of 3 months
Gene and protein level evaluation of the endometrial biopsies collected.
Different molecular and histological assays will be performed with the biopsies from all the groups.
Measured: An average of 3 years
Study of the molecular composition of the different plasma fractions obtained from collected umbilical cord samples.
Different molecular assays will be performed with the blood samples obtained.
Measured: An average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start22 Apr 2022
- Primary completion27 Jan 2025
- Study completion27 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Recruitment period: * Umbilical cord donors: throughout the study. Although the aim is to recruit the maximum number of umbilical cord samples during the first 10±3 months of the study. 30±15 donors will be recruited. * Patients (group A and B): from month 4 of the first year until the end of the study. * Expected duration of treatment per patient: * Group A (arms 1 and 2): 22±8 days (visit 2 to visit 3). * Group B: 22±8 days (visit 2 to visit 3).
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación IVI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mónica Romeu Villaroya, MD., PhD., Principal investigator, Hospital La FeIrene Cervelló Alcaráz, PhD., Study director, IVI Foundation/ IIS La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095597
- Sponsor's protocol ID
- 2001-FIVI-002-IC
- Other IDs
- 2020-005717-40
- Acronym
- hSCU-PRP
- Status last verified
- Mar 2025
- First submitted
- 30 Sep 2021
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbilical Cord Plasma for Treating Endometrial Pathologies (Thin Endometrium / Asherman's Syndrome/ Endometria Atrophy).
- ClinicalTrials.gov ID
- NCT05095597
- Acronym / sponsor ID
- hSCU-PRP / 2001-FIVI-002-IC
- Conditions
- Asherman Syndrome, Endometrial Atrophy
- Keywords
- Endometrial pathology, Platelet-rich plasma, Umbilical cord blood, Regenerative medicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Fundación IVIUniversity, hospital or other
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 27 Jan 2025 (actual)
- Study completion
- 27 Jan 2025 (actual)
- First posted
- 27 Oct 2021 (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.
In the last years, platelet-rich plasma (PRP) has emerged as a promising alternative to treat endometrial pathologies affecting the endometrial lining. Different studies have tried this therapeutic approach in human patient, but results are not conclusive at all. Also, in the last years, different studies have suggested the umbilical cord blood has a stronger reservoir of growth factors and other pro-regenerative molecules than the adult peripheral blood. That is the reason why the present study aims to evaluate if using platelet-rich plasma obtained from umbilical cord blood is able to increase endometrial thickness and prepare the endometrium for an embryo transference. However, due to the novelty of this approach, the investigators have considered to include a 'proof of concept' group (women with premature ovarian insufficiency) to obtain a deeper understanding of the clinical value of this blood derivative.
Detailed description
Phase II clinical trial, designed as a pilot study, single-center and open-label, which aims to study the efficacy of platelet-rich plasma from umbilical cord after injection into a pathological endometrium (thin endometrium, Asherman's Syndrome, endometrial atrophy).
This treatment will be applied to patients with the aforementioned endometrial pathologies (group B), as well as to patients with premature ovarian failure (group A), which will serve to study its clinical value in greater detail. Plasma samples as well as endometrial biopsies will be analyzed to try to understand what molecular events are triggered in the endometrial tissue after the application of the treatment under study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Recruitment period: * Umbilical cord donors: throughout the study. Although the aim is to recruit the maximum number of umbilical cord samples during the first 10±3 months of the study. 30±15 donors will be recruited. * Patients (group A and B): from month 4 of the first year until the end of the study. * Expected duration of treatment per patient: * Group A (arms 1 and 2): 22±8 days (visit 2 to visit 3). * Group B: 22±8 days (visit 2 to visit 3).
| Arm | Type | Receives |
|---|---|---|
| Umbilical cord PRP donors | Other | Procedure: Umbilical cord blood collectionWomen who are going to give birth to a healthy live newborn at the Hospital Universitario y Politécnico La Fe. Donors will donate their umbilical cord blood to obtain the hUC-PRP. A total of 30±15 donors will be recruited. |
| Group B- Asherman with PRP treatment and estrogen therapy | Experimental | Procedure: Injection of hUC-PRP by hysteroscopy, Drug: Oestraclin, Procedure: Endometrial biopsyWomen with thin endometrium/endometrial atrophy and/or Asherman's syndrome with fertility problems and reproductive desires, desires that could be achieved by their participation in the present study. A total of 15 patients will be included; all of them will receive the investigational treatment as well as estrogen therapy. |
| Group A1- POI with PRP treatment and estrogen therapy | Other | Procedure: Injection of hUC-PRP by hysteroscopy, Drug: Oestraclin, Procedure: Endometrial biopsyWomen with premature ovarian failure (POI). A total of 10 patients will be included. All of them will receive the investigational treatment as well as estrogen therapy. |
| Group A2- POI with estrogen therapy | Other | Drug: Oestraclin, Procedure: Endometrial biopsyWomen with premature ovarian failure (POI). A total of 10 patients will be included. All of them will receive the estrogen therapy. |
| Group A3- POI without PRP treatment nor estrogen therapy | Other | Procedure: Endometrial biopsyWomen with premature ovarian failure (POI). A total of 10 patients will be included. None of them will receive either the investigational treatment nor estrogen therapy. |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patient information sheet and signed informed consent.
- Female, acting voluntarily, aged between 18 and 48 years at the time of recruitment.
- BMI ≥ 18 kg/m2 and ≤ 35 kg/m2.
- Patients with premature ovarian failure (amenorrhea prior to 40 years of age and FSH > 40 IU/L).
- Information and signed informed consent.
Key exclusion criteria (13 listed)
- Active genital infection proven at the time of recruitment; chronic endometritis.
- Known endometrial pathology.
- Psychological disorder that may hinder study follow-up.
- Positive results after viral safety analysis (HBsAg, HBcAb, HCV, HIV1, HIV2, syphilis).
- Presenting any syndrome or condition that, from the principal investigator's point of view, could pose a risk to the study or to the patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection of hUC-PRP by hysteroscopyPRP previously frozen at -80ºC (6±2 mL) will be defrozen after checking donor-receptor compatibility and viral safety study. PRP (4±2 mL) will be activated with 5% CaCl2 and immediately injected (4±2 mL) in the sub-endometrial wall via hysteroscopy. | Procedure or surgery | Group A1- POI with PRP treatment and estrogen therapy, Group B- Asherman with PRP treatment and estrogen therapy |
| OestraclinPatients will receive estrogenic therapy, based on estradiol, for 10±2 days (oestraclin, topical cream, 5µg daily for 10±2 days). | Drug | Group A1- POI with PRP treatment and estrogen therapy, Group A2- POI with estrogen therapy, Group B- Asherman with PRP treatment and estrogen therapy |
| Umbilical cord blood collectionThe SCU will be collected using a blood collection bag containing anticoagulant. This step will be performed by the medical and nursing staff of the obstetrics service of the HUP La Fe. The blood collection bags will be the following, or similar: Cord Blood Collection Bags from MACOPHARMA; CPD Umbilical Cord Bag from GRIFOLS. | Procedure or surgery | Umbilical cord PRP donors |
| Endometrial biopsyBiopsies will be taken by specialized medical personnel by aspiration with an intrauterine cannula (pipelle or cornier). Samples will be collected in 15 mL tubes (or in a larger capacity container if needed) containing PBS or RNA later until frozen at -80ºC, at the IVI Foundation facilities. Prior to freezing (in a 1.8-2 mL cryotube) the PBS will be removed and the sample cleaned in a Petri dish if needed. | Procedure or surgery | Group A1- POI with PRP treatment and estrogen therapy, Group A2- POI with estrogen therapy, Group A3- POI without PRP treatment nor estrogen therapy, Group B- Asherman with PRP treatment and estrogen therapy |
Primary outcome
Study of endometrial regeneration and/or improvement in patients with endometrial pathologies (thin endometrium/Asherman's syndrome/endometrial atrophy) treated with platelet-rich plasma from the umbilical cord by endometrial thickeness.
Time frame: An average of 3 months
Improvement will be studied in form of tissue thickening (mm), comparing endometrial thickness before and after PRP injection
3 secondary outcomes
Proof-of-concept in POI patients by improvement endometrial thickeness.
Time frame: An average of 3 months
Gene and protein level evaluation of the endometrial biopsies collected.
Time frame: An average of 3 years
Study of the molecular composition of the different plasma fractions obtained from collected umbilical cord samples.
Time frame: An average of 3 years
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 24 Sep 2025.
- Individual participant dataSharing planned: No. All IPD that underlie results in a publication
Related trials for Asherman Syndrome
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Bone Marrow Derived Stem Cells Mobilization for Treatment of Abnormal Endometrium
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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.
Mónica Romeu Villaroya, MD., PhD. principal investigator
Hospital La Fe
Irene Cervelló Alcaráz, PhD. study director
IVI Foundation/ IIS La Fe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Injection of hUC-PRP by hysteroscopy, Oestraclin and Umbilical cord blood collection in people with 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 9 inclusion and 13 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 24 Sep 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Study of endometrial regeneration and/or improvement in patients with endometrial pathologies (thin endometrium/Asherman's syndrome/endometrial atrophy) treated with platelet-rich plasma from the umbilical cord by endometrial thickeness. (time frame: An average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2025.