Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Premature
A single-center, prospective, randomised controlled clinical trial (1:1 treatment ratio), designed to investigate the efficacy and safety of autologous SVF in improving the pregnancy outcome of infertile patients with POI.
| Condition(s) | Premature Ovarian Insufficiency |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | A single-center, prospective, randomised controlled clinical trial (1:1 treatment ratio), designed to investigate the efficacy and safety of autologous SVF in improving the pregnancy outcome of infertile patients with POI. |
| Who can participate | Inclusion Criteria: * Women aged ≥20 and ≤39 years who have childbearing requirements. * Cessation of menstruation or oligomenorrhea for at least 4 months * Serum level of basal follicle stimulating hormone (FSH) \>25 U/L at least 2 times (during the second to fourth day of the menstrual cycle or during amenorrhea; The interval between the two tests is 4 weeks) * Serum level of Anti-Mullerian hormone (AMH) ≤1.1 ng/ml * Women with intact uterus and bilateral adnexa. * Voluntary participation and informed consent obtained. Exclusion Criteria: * Women with autoimmune diseases. * Women with abnormal and uncontrolled thyroid function. * Women with tumors in bilateral adnexa that are not clearly benign or malignant. * Women with a history of malignant tumors, radiation therapy or chemotherapy. * |
| Ages | 20 Years to 39 Years |
| Sex | Female |
| Lead sponsor | Rui Yang |
| Locations | Beijing, Beijing Municipality, China |
| Start date | 2024-07-23 |
| NCT ID | NCT06481969 |
| Official listing | https://clinicaltrials.gov/study/NCT06481969 |