Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Premature Ovarian Insufficiency (aSVF-POI)

Rui Yang

Status: Enrolling

Conditions: Premature Ovarian Insufficiency

Treatments: Procedure: Conventional IVF; Procedure: Lower abdominal liposuction and preparation of SVF; Procedure: Ovarian injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06481969

SF2024-2-40911

Details and patient eligibility

About

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.

Full description

A single-center, large-scale, prospective, randomized controlled clinical trial will enroll 260 patients diagnosed with POI based on the inclusion and exclusion criteria from Peking University Third Hospital. Eligible participants will be randomized to two groups at a ratio of 1:1- SVF protocol, and conventional protocol.The participation in this study will be approximately 2 years with a total of 6 visits and 3 follow-up phone calls.

Enrollment: 260 estimated patients

Sex: Female

Ages: 20 to 39 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

260 participants in 2 patient groups

Group A-SVF group

Experimental group

Description:

Qualified participants will be randomized into either of two groups. Participants in this group will undergo lower abdominal liposuction, preparation of SVF and ovarian injection, other standard assisted reproductive treatments are similar and parallel between two groups.

Treatment:

Procedure: Ovarian injection

Procedure: Lower abdominal liposuction and preparation of SVF

Group B-Control group

Other group

Description:

Qualified participants will be randomized into either of two groups. Participants in this group will be treated according to the current clinical routine of the reproductive center, other standard assisted reproductive treatments are similar and parallel between two groups.

Treatment:

Procedure: Conventional IVF