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New treatment option for Premature Ovarian Insufficiency
Official title Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Premature Ovarian Insufficiency
ClinicalTrials.gov ID: NCT06481969
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 39, women only
You may be able to join if
- 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...
- Serum level of Anti-Mullerian hormone (AMH) ≤1.1 ng/ml
- Women with intact uterus and bilateral adnexa.
You likely can't join if
- 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...
See the full eligibility 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 20 years to 39 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.