Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Premature Ovarian Insufficiency
- Conditions
- Premature Ovarian Insufficiency
- Interventions
- Procedure: Conventional IVFProcedure: Lower abdominal liposuction and preparation of SVFProcedure: Ovarian injection
- Registration Number
- NCT06481969
- Lead Sponsor
- Rui Yang
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 260
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group B-Control group Conventional IVF 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. Group A-SVF group Lower abdominal liposuction and preparation of SVF 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. Group A-SVF group Ovarian injection 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.
- Primary Outcome Measures
Name Time Method The cumulative clinical pregnancy rate in half a year half a year after treatment Percentage of patients with clinical pregnancy within half a year after treatment
- Secondary Outcome Measures
Name Time Method Serum level of Anti-Mullerian hormone (AMH) half a year after treatment Efficacy rate (%) = The number of patients with two consecutive increases in serum level of AMH after treatment / total number of included patients×100%
Antral follicles count (AFC) half a year after treatment Efficacy rate (%) = The number of patients with bilateral ovarian AFC increases by at least 2 after treatment / total number of included patients×100%
Serum level of sex hormone (E2 and FSH) half a year after treatment Efficacy rate (%) = The number of patients with two consecutive increases/decreases in serum level of E2/FSH after treatment / total number of included patients×100%
Pregnancy outcome 2 years after treatment Live births or miscarriage of patients with successful pregnancy within half a year will be followed up. Live birth defined as the delivery of at least one viable fetus after 24 weeks gestation. Miscarriage defined as a loss of pregnancy before 24 weeks gestation. Live birth rate (%) = The number of patients with live births after treatment / total number of included patients×100%. Miscarriage rate (%) = The number of patients with miscarriage after treatment / total number of included patients×100%.
Adverse reactions 2 years after treatment The frequency, date of onset, duration and severity of any local and systemic adverse reactions will be observed and recorded during the entire follow-up period. Incidence rate of adverse reactions (%) = The number of patients with adverse reactions after treatment / total number of included patients×100%.
Menstrual status half a year after treatment The frequency, duration and volume of menses within half a year after treatment will be recorded to evaluate whether the menstrual status of patients have improved. Menstrual recovery rate (%) = The number of patients with menstrual recovery after treatment / total number of included patients × 100%.
Ovarian volume half a year after treatment Ovarian volume will be recorded before and after treatment. Paired sample t-test or independent sample t-test will be used to compare the changes in ovarian volume between the control and SVF treatment groups, P \< 0.05 will be recorded as significant change in ovarian volume.
Health status of offspring 2 years after treatment The health status (survival, physiological and intellectual development) of offspring will be followed up via telephone for 2 years.
Trial Locations
- Locations (1)
Peking University Third Hospital
🇨🇳Beijing, Beijing, China