Clinical study on the safety and efficacy of in-situ ovarian injection of umbilical cord mesenchymal stem cells in the treatment of premature ovarian insufficiency

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200056751

Enrollment

Unknown

Registered

2022-02-13

Start date

2021-12-15

Completion date

Unknown

Last updated

2023-09-11

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

Conditions

Premature ovarian insufficiency

Interventions

Group A:Recombinant human growth hormone

in-situ ovarian injection of umbilical cord mesenchymal stem cells

Group B:Recombinant human growth hormone

Eligibility

Sex/Gender

Female

Age

20 Years to 39 Years

Inclusion criteria

Inclusion criteria: 1. The intention of pregnant women aged >= 20 and 25 IU/l on two occasions >4 weeks apart; 4. Without a history of stem cell therapy and no growth hormone and/or estrogen and progesterone therapy within the previous 3 months; 5. Voluntary participation in the study with signed informed consent; 6. Patients who do not respond to conventional treatment.

Exclusion criteria

Exclusion criteria: 1. Unable to follow the treatment observation process required by the trial; 2. Genetic diseases, chromosomal abnormalities, and genetic deficiency that clearly cause premature ovarian insufficiency/premature ovarian failure; 3. With breast, uterine, ovarian tumors, or any other benign or malignant tumors; 4. Allergic history to drugs or any other things; 5. Primary amenorrhea; 6. Anatomic abnormalities of uterine; 7. Iatrogenic ovarian insufficiency; 8. Uncontrollable acute and chronic gynecological inflammation (including endometritis, etc.); 9. Double-layer endometrium thickness <= 8mm after operation for moderate and severe intrauterine adhesions; 10. With endometriosis; 11. Severe organs deficiency and abnormal coagulation; 12. High risks of venous thromboembolism; 13. Abnormalities in CBC, urinalysis, fecal test, coagulation test, liver and kidney function test, ECG, chest X-ray, and other pre-operative examinations; 14. Contraindications to growth hormone use; 15. Other factors affecting pregnancy.

Design outcomes

Primary

Measure	Time frame
Basal sex hormone level;Ovarian changes;	—

Secondary

Measure	Time frame
Pregnancy rate;Live birth rate;Menstrual changes;	—

Countries

China

Contacts

Public ContactSongying Zhang

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

zhangsongying@zju.edu.cn+86 13805727588

Outcome results

None listed

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