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

Rui Yang1 site in 1 country260 target enrollmentJuly 23, 2024

ConditionsPremature Ovarian Insufficiency

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Premature Ovarian Insufficiency
Sponsor: Rui Yang
Enrollment: 260
Locations: 1
Primary Endpoint: The cumulative clinical pregnancy rate in half a year
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 23, 2024

End Date

December 30, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Rui Yang

Responsible Party

Sponsor Investigator

Principal Investigator

Rui Yang

Clinical associate professor

Peking University Third Hospital

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.