Can stem cell exosomes heal the womb and boost fertility?
NCT ID NCT07416578
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether infusing stem cell exosomes into the uterus can repair the lining in women with intrauterine adhesions (scarring). Sixty women aged 20-38 will receive either exosomes plus hormone therapy or hormone therapy alone after hysteroscopy. The goal is to see if the exosomes improve endometrial thickness and pregnancy rates.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- umbilical cord mesenchymal stem cell exosomes
- What this could lead to
- If it works, this could offer a new treatment to repair the uterine lining in women with intrauterine adhesions, potentially improving pregnancy and live birth rates.
- What could go wrong
- This is an early-stage study with only 60 participants, so results may not apply to everyone. Exosome therapy is still experimental, and its long-term safety and effectiveness are not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 to 38 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * (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). Exclusion Criteria: * (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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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No. 26, Second Horizontal Road, Yan Village, Tianhe District
Guangzhou, Guangdong, 510600, China
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Other studies related to the condition(s) this trial covers.
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