Could stem cells heal a scarred uterus and restore fertility?
NCT ID NCT07176143
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests whether delivering stem cells from bone marrow directly into the uterine artery can repair severe scarring inside the uterus (intrauterine adhesions) and improve pregnancy rates. Sixty women aged 20-38 with infertility due to this scarring will receive either standard hormone therapy alone or hormone therapy plus the stem cell infusion. Researchers will compare pregnancy success after embryo transfer to see if the stem cell approach is safe and effective.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- human bone marrow mesenchymal stem cells
- What this could lead to
- If it works, this could offer a new treatment for women with severe uterine scarring who cannot get pregnant, potentially improving their chances of having a baby.
- What could go wrong
- This is an early-stage trial with only 60 participants, so results may not apply to everyone. The procedure carries risks like allergic reactions or pain, and the stem cells may not effectively repair the uterus.
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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.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
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. Subjects fully comprehend the screening process and study objectives, demonstrate adequate understanding of and compliance with the trial protocol, and provide signed informed consent. 2. Age between 20 and 38 years. 3. Body mass index (BMI) 18-27 kg/m². 4. Regular menstrual cycles (27-35 days) for ≥6 months. 5. Normal ovarian reserve: Antral follicle count (AFC) ≥6; Follicle-stimulating hormone (FSH) 1-10 IU/L on cycle days 2-4; Baseline sex hormones within normal laboratory ranges. 6. Negative serology within 6 months for: HIV antibodies; Treponema pallidum antibodies (TPA); Hepatitis B surface antigen (HBsAg); Hepatitis C virus antibodies (HCV-Ab). 7. ≥2 good-quality blastocysts (D5/D6) according to Gardner grading criteria. 8. Prior hysteroscopic diagnosis of severe intrauterine adhesions (IUA) treated with electroresection, with normal uterine cavity morphology confirmed by hysteroscopy within 3 months. 9. History of canceled frozen embryo transfers due to persistently thin endometrium (\<6 mm) in HRT and/or natural cycles during the late proliferation phase. Exclusion Criteria: 1. Ovarian cysts ≥20 mm, submucosal/intramural uterine fibroids \>30 mm, pituitary tumors, or malignancy in any organ. 2. Clinically significant uterine (endometrial polyps, IUA, malformations, endometriosis) or adnexal (hydrosalpinx) abnormalities. 3. Recurrent implantation failure (≥3 consecutive transfers with ≥6 good-quality embryos failing). 4. Unexplained abnormal vaginal bleeding. 5. Active pelvic inflammatory disease. 6. Reproductive tract malformations incompatible with pregnancy. 7. Abnormal cervical cytology (TCT) within 1 year before screening. 8. Severe hepatic/renal impairment, cardiac disease, or hypertension. 9. History of thrombophlebitis or thromboembolism. 10. Platelet count \<100×10⁹/L, hemoglobin \<100 g/L, or hematologic disorders (e.g., idiopathic thrombocytopenic purpura). 11. Clinically significant systemic diseases (e.g., diabetes, tuberculosis). 12. History of recurrent miscarriage. 13. Chromosomal abnormalities in either partner. 14. Genetic disorders (per Maternal and Infant Health Care Law) contraindicating pregnancy in either partner. 15. Exposure to teratogenic radiation, toxins, or medications in either partner. 16. Participation in other drug/device trials within 3 months prior to enrollment. 17. Any condition (comorbidity, surgery, medication, or abnormal lab results) deemed by investigators to affect trial outcomes. 18. Inability or refusal to comply with protocol requirements (including scheduled visits and tests).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
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How to take part
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The official record
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