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NCT07901218
Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Diminished Ovarian Reserve
Conditions: Diminished Ovarian Reserve (DOR)
Sex: Female
Ages: 20 Years – 39 Years
Healthy volunteers: No
Phase: NA
Enrollment: 260
Sponsor: Peking University Third Hospital
Location: The Third Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong
Summary
A multi-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 DOR.
Eligibility Criteria
Inclusion Criteria:
* Women of childbearing age (20-39 years old) with fertility needs.
* The following conditions must be met simultaneously: ① Basal FSH \> 10 IU/L (measured on days 2-4 of menstruation); ② Total number of bilateral AFC \< 5 (by transvaginal ultrasound, measured on days 2-4 of menstruation); ③ AMH \< 1.2 ng/mL.
* Previous controlled ovarian stimulation resulted in no more than 3 retrieved oocytes and/or no viable embryos for transfer and/or more than 2 previous embryo transfer failures; or previous inability to enter the ovarian stimulation cycle due to FSH levels ≥ 20 IU/L.
* The uterus and both ovaries are present, and the informed consent form is signed.
Exclusion Criteria:
* Suffering from autoimmune diseases or other endocrine disorders and the conditions are not under control;
* Having a history of gynecological malignant tumors or radiotherapy and chemotherapy; having malignant tumors in the adnexal area, or having a mass with an unclear benign or malignant nature; having a family history of gynecological malignant tumors;
* Having a history of venous thrombosis or pulmonary embolism;
* Having a history of malignant tumors, acute or chronic infectious diseases, hematological diseases or other diseases that affect the removal of fat during surgery and ovarian injection;
* Having serious diseases that are not suitable for pregnancy and have been judged by the investigator to potentially affect the efficacy or safety evaluation, such as circulatory system diseases, urinary system diseases, digestive system diseases, endocrine system diseases, respiratory system diseases, immune system diseases, mental or neurological diseases, etc.;
* Using systemic glucocorticoids or other immunosuppressants continuously for ≥ 3 weeks within 6 months before administration, or using systemic glucocorticoids (prednisone ≥ 20mg/d or equivalent dose) or other immunosuppressants within 3 days before administration.
Source: ClinicalTrials.gov (NCT07901218). StuddyBuddy aggregates publicly available trial information.