Using fat-derived cells to treat premature ovarian insufficiency

Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Premature Ovarian Insufficiency

This study is testing if using fat-derived cells can help improve pregnancy chances for women with premature ovarian insufficiency compared to standard IVF treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 260 (estimated)
• Ages: 20 Years to 39 Years
• Sex: Female
• Sponsor: Peking University Third Hospital (other)
• Drugs / interventions: chemotherapy, radiation, prednisone
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06481969 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness and safety of using autologous adipose stromal vascular fraction (SVF) to improve pregnancy outcomes in women with premature ovarian insufficiency (POI). A total of 260 participants will be enrolled and randomly assigned to receive either the SVF treatment or conventional IVF. The study will take place over approximately two years, involving six visits and three follow-up phone calls to monitor progress and outcomes. The goal is to determine if SVF can enhance fertility in this patient population.

Who should consider this trial

Good fit: Ideal candidates are women aged 20 to 39 with diagnosed premature ovarian insufficiency and a desire to conceive.

Not a fit: Patients with autoimmune diseases, uncontrolled thyroid issues, or a history of certain cancers may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve fertility options for women suffering from premature ovarian insufficiency.

How similar studies have performed: While the use of SVF in fertility treatments is an emerging area, there is limited prior success in similar studies, making this approach relatively novel.

Eligibility criteria

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.
* Women with a history of venous thrombosis or pulmonary embolism during the screening period.
* Women with severe illnesses that are not suitable for pregnancy, such as diseases of the circulatory system, urinary system, digestive system, endocrine system, respiratory system, immune system, mental or neurological system, etc.
* Women who continuously used systemic glucocorticoids or other immunosuppressants for≥3 weeks within 6 months before administration and women who used systemic glucocorticoids (prednisone≥20 mg/d or equivalent dose) or other immunosuppressants within 3 days before administration.
* Women who are allergic to the active ingredients or excipients of test drugs.
* Women with a family history of severe genetic diseases or gynecologic malignancies.

Where this trial is running

Beijing, Beijing Municipality

• Peking University Third Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Rui Yang, M.D.

Conditions: Premature Ovarian Insufficiency, Female fertility, Adipose stromal vascular fraction