Clinical trial NCT06481969: Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Premature Ovarian Insufficiency
Official title: Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Premature Ovarian Insufficiency
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature Ovarian Insufficiency
Keywords: Female fertility
Premature Ovarian Insufficiency
Adipose stromal vascular fraction
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 260
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible participants will be randomized to two groups at a ratio of 1:1- SVF protocol, and conventional protocol.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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.

Primary outcomes:
measure: The cumulative clinical pregnancy rate in half a year
timeFrame: half a year after treatment
Secondary outcomes:
measure: Serum level of Anti-Mullerian hormone (AMH)
timeFrame: half a year after treatment
measure: Antral follicles count (AFC)
timeFrame: half a year after treatment
measure: Serum level of sex hormone (E2 and FSH)
timeFrame: half a year after treatment
measure: Ovarian volume
timeFrame: half a year after treatment
measure: Menstrual status
timeFrame: half a year after treatment
measure: Pregnancy outcome
timeFrame: 2 years after treatment
measure: Health status of offspring
timeFrame: 2 years after treatment
measure: Adverse reactions
timeFrame: 2 years after treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Rui Yang, M.D.
role: STUDY_DIRECTOR
References: