Using fat-derived cells to treat premature ovarian insufficiency

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Peking University Third Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Rui Yang, M.D.
• Email: yrjeff@126.com
• Phone: +86-010-82265080

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Autologous Hair Follicle Secretome + PRP for POI

  This pilot study tests whether a patient’s own hair follicle secretome combined with their own platelet-rich plasma can improve ovarian function in women with premature ovarian insufficiency.

  Recruiting Phase 2 Trio Fertility · Toronto, Ontario · NCT07916740

• Intravenous hUC-MSCs for POI: Safety, Tolerability and Early Efficacy

  We’re testing whether IV human umbilical cord mesenchymal stem cells can be safely given to women under 40 with premature ovarian insufficiency to see if it helps improve ovarian function.

  Recruiting Phase 1/2 Shenzhen Wingor Biotechnology Co., Ltd. · Beijing, Beijing Municipality · NCT07775391

• Human amniotic mesenchymal stem cell treatment for premature ovarian insufficiency

  This trial will test whether an intravenous infusion of human amniotic mesenchymal stem cells combined with standard hormone therapy can help women under 40 with premature ovarian insufficiency.

  Recruiting Phase 1/2 Changhai Hospital · Shanghai · NCT07115082

• Hormone replacement for adolescents with premature ovarian insufficiency

  This study will test estrogen patches plus progesterone in girls and young women aged 11–19 with premature ovarian insufficiency to see if hormone replacement improves bone density, metabolic markers, muscle strength, and cardiovascular health.

  Recruiting Phase 3 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT06851754

• Using Platelet-rich Plasma to Improve Female Fertility

  This study is testing whether injections of platelet-rich plasma can help improve fertility in women dealing with issues like poor ovarian response and repeated implantation failure.

  Recruiting The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Yiwu, Zhejiang · NCT06645379

• Examining the link between ovarian function and serum biomarkers

  This study is trying to see how blood markers differ between healthy women and those with ovarian issues to better understand their connection.

  Recruiting Dongzhimen Hospital, Beijing · Beijing · NCT06096766

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.