Asherman SyndromeCURENDONCT07697924
CURENDO (Cord-blood Uterine Regeneration Endometrium): Platelet-rich Plasma Therapy Derived From Umbilical Cord Blood for the Treatment of Endometrial Pathologies (Asherman Syndrome / Endometrial Atrophy / Thin Endometrium)
A study testing Umbilical cord platelet-rich plasma (hUC-PRP) in people with Asherman Syndrome, run by Fundación IVI at 1 site in Spain.
Trial summary
In recent years, platelet-rich plasma (PRP) has emerged as a promising alternative for treating endometrial pathologies that affect the endometrial lining. Several studies have tested this therapeutic approach in human patients, but the results are inconclusive. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Asherman Syndrome
- What is being tested?
- Umbilical cord platelet-rich plasma (hUC-PRP)
- Type of treatment
- Injection or infusion
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- 18 Dec 2025to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- age between 18 and 48 years at the time of recruitment
- body mass index (BMI): ≥ 18 kg/m2 and ≤ 35 kg/m2
- endometrial thickness < 5 mm despite estrogen administration according to each clinic's routine practice for 10 or more days and/or evidence of Asherman syndrome.
Who cannot join
- Active genital infection at the time of recruitment
- chronic endometritis
- known endometrial pathology
- psychiatric disorder that could hinder study follow-up
- positive results on viral safety testing (HBsAg, HBcAb, HCV, HIV-1, HIV-2, syphilis)
- presence of any syndrome or condition that, in the opinion of the principal investigator, could pose a risk to the study or to the patient
- any clinically significant abnormality detected during the recruitment process
- simultaneous participation in another clinical study that could affect the objectives of the present study, or prior participation in this same study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
IVI Valencia
Valencia
Irene Cervello Irene Cervello, 651 79 10 00, irene.cervello@ivirma.com
About this study
In recent years, platelet-rich plasma (PRP) has emerged as a promising alternative for treating endometrial pathologies that affect the endometrial lining. Several studies have tested this therapeutic approach in human patients, but the results are inconclusive. Moreover, in recent years, different investigations have suggested that PRP derived from umbilical cord blood (hUC-PRP) contains a higher concentration of growth factors and other pro-regenerative molecules than PRP obtained from adult peripheral blood. In our previous pilot study conducted in 15 patients with endometrial atrophy/Asherman syndrome/thin endometrium, preliminary results indicate that hysteroscopic injection of hUC-PRP increases endometrial thickness and improves the endometrial pattern. For this reason, the present study aims to corroborate our previous findings by increasing the number of patients to 35, in prior HRT cycles in these women, to gain a deeper understanding of the effectiveness of this new therapy.
- Conditions
- Asherman Syndrome
- Being tested
- Umbilical cord platelet-rich plasma (hUC-PRP)
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord platelet-rich plasma (hUC-PRP)Other
Umbilical cord platelet-rich plasma (hUC-PRP) obtained from samples sourced from a cord blood bank, which will be activated with 5% CaCl₂ prior to injection into the subendometrial wall of the uterine cavity via hysteroscopy. All patients will receive a single administration of allogeneic hUC-PRP after 10±2 days of estrogen treatment during the treatment phase.
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in endometrial thickness following treatment with hUC-PRP, calculated as the difference between the endometrial thickness after treatment and the patient's initial endometrial thickness (mm).
If more than one endometrial thickness measurement is recorded, the average of the measurements will be calculated.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start18 Dec 2025
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación IVI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697924
- Sponsor's protocol ID
- 2411-FIVI-218-IC
- Acronym
- CURENDO
- Status last verified
- Jun 2026
- First submitted
- 2 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CURENDO (Cord-blood Uterine Regeneration Endometrium): Platelet-rich Plasma Therapy Derived From Umbilical Cord Blood for the Treatment of Endometrial Pathologies (Asherman Syndrome / Endometrial Atrophy / Thin Endometrium)
- ClinicalTrials.gov ID
- NCT07697924
- Acronym / sponsor ID
- CURENDO / 2411-FIVI-218-IC
- Conditions
- Asherman Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Fundación IVIUniversity, hospital or other
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 13 Jul 2026 (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 recent years, platelet-rich plasma (PRP) has emerged as a promising alternative for treating endometrial pathologies that affect the endometrial lining. Several studies have tested this therapeutic approach in human patients, but the results are inconclusive. Moreover, in recent years, different investigations have suggested that PRP derived from umbilical cord blood (hUC-PRP) contains a higher concentration of growth factors and other pro-regenerative molecules than PRP obtained from adult peripheral blood. In our previous pilot study conducted in 15 patients with endometrial atrophy/Asherman syndrome/thin endometrium, preliminary results indicate that hysteroscopic injection of hUC-PRP increases endometrial thickness and improves the endometrial pattern. For this reason, the present study aims to corroborate our previous findings by increasing the number of patients to 35, in prior HRT cycles in these women, to gain a deeper understanding of the effectiveness of this new therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age between 18 and 48 years at the time of recruitment
- body mass index (BMI): ≥ 18 kg/m2 and ≤ 35 kg/m2
- endometrial thickness < 5 mm despite estrogen administration according to each clinic's routine practice for 10 or more days and/or evidence of Asherman syndrome.
Key exclusion criteria (8 listed)
- Active genital infection at the time of recruitment
- chronic endometritis
- known endometrial pathology
- psychiatric disorder that could hinder study follow-up
- positive results on viral safety testing (HBsAg, HBcAb, HCV, HIV-1, HIV-2, syphilis)
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 |
|---|---|---|
| Umbilical cord platelet-rich plasma (hUC-PRP)Umbilical cord platelet-rich plasma (hUC-PRP) obtained from samples sourced from a cord blood bank, which will be activated with 5% CaCl₂ prior to injection into the subendometrial wall of the uterine cavity via hysteroscopy. All patients will receive a single administration of allogeneic hUC-PRP after 10±2 days of estrogen treatment during the treatment phase. | Other | – |
Primary outcome
Increase in endometrial thickness following treatment with hUC-PRP, calculated as the difference between the endometrial thickness after treatment and the patient's initial endometrial thickness (mm).
Time frame: 8 weeks
If more than one endometrial thickness measurement is recorded, the average of the measurements will be calculated.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Umbilical cord platelet-rich plasma (hUC-PRP) in people with Asherman Syndrome, 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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 13 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in endometrial thickness following treatment with hUC-PRP, calculated as the difference between the endometrial thickness after treatment and the patient's initial endometrial thickness (mm). (time frame: 8 weeks). 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 13 Jul 2026.