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Human Uterine Transplantation Research

Study on allogeneic uterine transplantation in women with uterine infertility

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053249
Enrollment
Unknown
Registered
2021-11-17
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Absolute uterine factor infertility

Interventions

Experimental group:Allogeneic uterus transplantation, postoperative immunosuppressive therapy, embryo transfer 1 year after operation, hysterectomy after cesarean section

Sponsors

Obstetrics and Gynecology Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Female, aged > 18 years and = 2 years; 4. Uterine infertility and desire to conceive through uterine transplantation; 5. No smoking, no drug or alcohol abuse; 6. No severe intra-abdominal adhesions; 7. Patients with malignant tumor have no recurrence for 5 years; 8. The vagina is replaced by a non-intestinal tube, and the length of the vagina is more than 7cm; 9. AFC > 8, AMH > 1.5µg/L; 10. LCT is normal, high-risk HPV screening is negative; 11. No HBV, HCV, HIV, human T-cell tropism virus (HTLV), CMV, Epstein-Barr virus, chlamydia, gonococcus, syphilis infection; 12. Preoperative ASA score: I-III; 13. No mental illness; 14. No diabetes, hypertension, cardiovascular and renal diseases; 15. No chronic obstructive pulmonary disease or tuberculosis; 16. No thrombotic disease; 17. Willing to accept postoperative immunosuppressive drugs, cesarean section and postpartum hysterectomy; 18. The patients voluntarily participated in the research and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Currently suffering from malignant tumors (including carcinoma in situ); 3. Major mental illness; 4. Male transgender people; 5. Those with contraindications to immunosuppressive drugs; 6. Contraindications for other organ transplantation; 7. Chromosomal abnormalities in either spouse; 8. The previous uterus transplant failed; 9. Active infectious disease in the past three months.

Design outcomes

Primary

MeasureTime frame
Graft survival past 12 months postoperatively;

Secondary

MeasureTime frame
Clinical pregnancy;Live birth;Operative time;Intraoperative blood loss;Complication rate;Hysterectomy within 30 days post-transplantation;

Countries

China

Contacts

Public ContactHua Keqin

Obstetrics and Gynecology Hospital of Fudan University

huakeqinjiaoshou@163.com+86 15921515900

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026