Intrauterine AdhesionsNCT07416578
Clinical Study on the Effect of Umbilical Cord Mesenchymal Stem Cell Exosomes on Endometrial Repair of Intrauterine Adhesions
A study testing Exosmoes and HRT in people with Intrauterine Adhesions and Exosomes, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
Intrauterine adhesions (IUA) is a group of diseases caused by endometrial injury leading to occlusion of the uterine cavity and serious abnormality of the uterine cavity morphology, which causes primary or secondary infertility by affecting embryo implantation. Read more about this study
- Who is it for?
- Ages 20 to 38 years, women only
- Conditions the study is for
- Intrauterine Adhesions, Exosomes
- What is being tested?
- Exosmoes and HRT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2026
- 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 20 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- (1) The subjects were able to fully understand the purpose of the screening and the trial, had sufficient understanding and compliance with the research protocol, and signed the informed consent form; (2) The subjects were aged between 20 and 38 years old; (3) The body mass index was 18-27 kg/m2; (4) The menstrual cycle was regular for at least half a year, with a duration of 27-35 days; (5) The ovarian reserve was normal, with at least 6 follicles (AFC), and the serum follicle-stimulating hormone (FSH) level on the 2nd-4th day of the menstrual cycle was between 1-10 IU/L, and other basic hormone indicators were within the normal range of clinical laboratories; (6) The serum human immunodeficiency virus (HIV) antibody, Treponema pallidum particle agglutination test (TPPA), hepatitis B surface antigen (HBsAg), and hepatitis C virus antibody (HCV-Ag) tests were negative within half a year; (7) Previous hysteroscopy diagnosis was moderate to severe intrauterine adhesions (AFS > 5 points); (8) There was a history of canceling frozen embryo transfer due to repeated B-ultrasound monitoring of thin endometrium and poor endometrial response (HRT cycle or/and late proliferative endometrium thickness < 6mm).
Who cannot join
- (1) Those who cannot accept the treatment and observation process as required by the trial; (2) Those with contraindications for hysteroscopic surgery; (3) Congenital uterine malformations; (4) Severe adenomyosis; (5) Uterine fibroids that may affect embryo implantation; (6) Other uterine factors judged by the researchers to be unsuitable for embryo implantation; (7) Patients with chromosomal abnormalities; (8) Patients with reproductive system tuberculosis, or those with immune system diseases (such as rheumatoid arthritis, systemic lupus erythematosus, etc.); (9) Chronic wasting or bleeding disorders; (10) Unaddressed tubal hydrosalpinx; (11) Contraindications for estrogen therapy; (12) Patients with systemic diseases， such as thrombosis， heart and lung diseases， hematological system diseases and malignant tumors， etc.
Trial locations and contacts
1 site in 1 country.
China1 site
No. 26, Second Horizontal Road, Yan Village, Tianhe District
Guangzhou, Guangdong, 510600
About this study
Intrauterine adhesions (IUA) is a group of diseases caused by endometrial injury leading to occlusion of the uterine cavity and serious abnormality of the uterine cavity morphology, which causes primary or secondary infertility by affecting embryo implantation. At present, the poor effectiveness of clinical treatment methods has made the thin endometrium after intrauterine adhesions an urgent problem to be solved in the clinical field of assisted reproduction.
Stem cells with multi-directional differentiation potential provide a new idea for the treatment of cervical adhesions. However, due to limitations such as stem cell extraction, technical conditions, and ethical issues, clinical application cannot be widely carried out. Exosomes are vesicle structures produced by paracrine secretion of cells, containing abundant proteins, RNA, etc., and mediating information exchange between cells. Recent studies have found that stem cells play a role in tissue repair mainly through paracrine, and stem cell-derived exosomes have similar functions to stem cells. Human cord mesenchymal stem cells were selected as an intervention for this clinical study because of their wide source, easy access, and low immunogenicity.
Therefore, in this clinical study, the investigator will evaluate the clinical safety and efficacy of infusing human umbilical cord mesenchymal stem cell exosomes into the uterine cavity for the treatment of thin endometrium after intrauterine adhesions.
- Conditions
- Intrauterine Adhesions, Exosomes
- Being tested
- Exosmoes, HRT
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExosmoesCombination product
After hysteroscopy, immediate intracavitary perfusion therapy with exosomes was administered.
HRTDrug
After hysteroscopy, traditional hormone replacement therapy (HRT) cycle drug treatment was performed (from the day of the surgery to the 25th day of the menstrual cycle, 3 mg of estradiol valerate (Climen) was taken twice a day, and on the 16th day of the menstrual cycle, 10 mg of dydrogesterone (Duphaston) was added twice a day for 10 days).
| Study group | Role | What they receive |
|---|---|---|
| The conventional treatment group | Other | traditional hormone replacement therapy Receives: Drug: HRT |
| Exosomes group | Experimental | Exosomes group：After hysteroscopic surgery, exosomes were infused into the uterus immediately, and traditional hormone replacement therapy (HRT) was given after surgery. Receives: Combination Product: Exosmoes; Drug: HRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial thickness
The thickness of the endometrium was measured through three-dimensional color ultrasound examination of the uterus. The thickness (in millimeters) of the endometrium before and after the hysteroscopy procedure was recorded.
Measured: One month after hysteroscopy surgery
Secondary outcomes (2)
Clinical pregnancy rate
By conducting regular postoperative follow-ups on the participants, the investigator can observe their pregnancy outcomes and record whether they have successfully achieved clinical pregnancy.
Measured: 1-1.5year
Live birth rate
By conducting regular postoperative follow-ups on the participates, the investigator can observe their pregnancy outcomes and record whether they have successfully achieved clinical pregnancy.
Measured: 1-1.5year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine AdhesionsStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The conventional treatment group and Exosomes group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, li tingting, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416578
- Sponsor's protocol ID
- 2023ZSLYFEC-005
- Status last verified
- Feb 2026
- First submitted
- 22 Jan 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Effect of Umbilical Cord Mesenchymal Stem Cell Exosomes on Endometrial Repair of Intrauterine Adhesions
- ClinicalTrials.gov ID
- NCT07416578
- Acronym / sponsor ID
- 2023ZSLYFEC-005
- Conditions
- Intrauterine Adhesions, Exosomes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Feb 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.
Intrauterine adhesions (IUA) is a group of diseases caused by endometrial injury leading to occlusion of the uterine cavity and serious abnormality of the uterine cavity morphology, which causes primary or secondary infertility by affecting embryo implantation. At present, the poor effectiveness of clinical treatment methods has made the thin endometrium after intrauterine adhesions an urgent problem to be solved in the clinical field of assisted reproduction.
Stem cells with multi-directional differentiation potential provide a new idea for the treatment of cervical adhesions. However, due to limitations such as stem cell extraction, technical conditions, and ethical issues, clinical application cannot be widely carried out. Exosomes are vesicle structures produced by paracrine secretion of cells, containing abundant proteins, RNA, etc., and mediating information exchange between cells. Recent studies have found that stem cells play a role in tissue repair mainly through paracrine, and stem cell-derived exosomes have similar functions to stem cells. Human cord mesenchymal stem cells were selected as an intervention for this clinical study because of their wide source, easy access, and low immunogenicity.
Therefore, in this clinical study, the investigator will evaluate the clinical safety and efficacy of infusing human umbilical cord mesenchymal stem cell exosomes into the uterine cavity for the treatment of thin endometrium after intrauterine adhesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The conventional treatment group and Exosomes group
| Arm | Type | Receives |
|---|---|---|
| The conventional treatment group | Other | Drug: HRTtraditional hormone replacement therapy |
| Exosomes group | Experimental | Combination Product: Exosmoes, Drug: HRTExosomes group：After hysteroscopic surgery, exosomes were infused into the uterus immediately, and traditional hormone replacement therapy (HRT) was given after surgery. |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- (1) The subjects were able to fully understand the purpose of the screening and the trial, had sufficient understanding and compliance with the research protocol, and signed the informed consent form; (2) The subjects were aged between 20 and 38 years old; (3) The body mass index was 18-27 kg/m2; (4) The menstrual cycle was regular for at least half a year, with a duration of 27-35 days; (5) The ovarian reserve was normal, with at least 6 follicles (AFC), and the serum follicle-stimulating hormone (FSH) level on the 2nd-4th day of the menstrual cycle was between 1-10 IU/L, and other basic hormone indicators were within the normal range of clinical laboratories; (6) The serum human immunodeficiency virus (HIV) antibody, Treponema pallidum particle agglutination test (TPPA), hepatitis B surface antigen (HBsAg), and hepatitis C virus antibody (HCV-Ag) tests were negative within half a year; (7) Previous hysteroscopy diagnosis was moderate to severe intrauterine adhesions (AFS > 5 points); (8) There was a history of canceling frozen embryo transfer due to repeated B-ultrasound monitoring of thin endometrium and poor endometrial response (HRT cycle or/and late proliferative endometrium thickness < 6mm).
Key exclusion criteria (1 listed)
- (1) Those who cannot accept the treatment and observation process as required by the trial; (2) Those with contraindications for hysteroscopic surgery; (3) Congenital uterine malformations; (4) Severe adenomyosis; (5) Uterine fibroids that may affect embryo implantation; (6) Other uterine factors judged by the researchers to be unsuitable for embryo implantation; (7) Patients with chromosomal abnormalities; (8) Patients with reproductive system tuberculosis, or those with immune system diseases (such as rheumatoid arthritis, systemic lupus erythematosus, etc.); (9) Chronic wasting or bleeding disorders; (10) Unaddressed tubal hydrosalpinx; (11) Contraindications for estrogen therapy; (12) Patients with systemic diseases， such as thrombosis， heart and lung diseases， hematological system diseases and malignant tumors， etc.
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 |
|---|---|---|
| ExosmoesAfter hysteroscopy, immediate intracavitary perfusion therapy with exosomes was administered. | Combination product | Exosomes group |
| HRTAfter hysteroscopy, traditional hormone replacement therapy (HRT) cycle drug treatment was performed (from the day of the surgery to the 25th day of the menstrual cycle, 3 mg of estradiol valerate (Climen) was taken twice a day, and on the 16th day of the menstrual cycle, 10 mg of dydrogesterone (Duphaston) was added twice a day for 10 days). | Drug | Exosomes group, The conventional treatment group |
Primary outcome
Endometrial thickness
Time frame: One month after hysteroscopy surgery
The thickness of the endometrium was measured through three-dimensional color ultrasound examination of the uterus. The thickness (in millimeters) of the endometrium before and after the hysteroscopy procedure was recorded.
2 secondary outcomes
Clinical pregnancy rate
Time frame: 1-1.5year
Live birth rate
Time frame: 1-1.5year
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 18 Feb 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exosmoes and HRT in people with Intrauterine Adhesions and Exosomes, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 18 Feb 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 China. 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?
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 (time frame: One month after hysteroscopy surgery). 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 18 Feb 2026.