A Phase 1 interventional study of AD-SVF in Endometrium; Atrophy and Intrauterine Synechiae, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Recruiting at 1 site in China. Open to female participants aged 22 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Phase 1, Interventional, and Treatment
The purpose of this study is to initially explore the efficacy of adipose-derived stromal vascular fraction (AD-SVF) therapy in the treatment of refractory endometrial infertility.
Patients with refractory thin endometrium (endometrial thickness \< 6 mm at late proliferative phase or after high-dose estrogen therapy) and/or moderate to severe intrauterine adhesion are recruited for fertility. After detailed explanation of the treatment plan, written informed consent will be obtained from the patients. The subjects undergo liposuction performed by plastic surgeons to obtain adipose tissue, from which AD-SVF is isolated and extracted for intrauterine infusion therapy. Six months post-AD-SVF treatment, the improvement in menstrual volume and endometrial thickness will be assessed during follow-up visits. The subjects will be advised, based on their personal inclination, to attempt conception (hysteroscopic surgery will be repeated if necessary), and their early pregnancy outcomes will be documented in subsequent follow-ups.
99 studies on the registry are indexed under Gynatresia; 23 are open to participants now.
This study's planned enrollment of 10 is below the median of 100 across 87 interventional studies indexed under Gynatresia.
Browse Gynatresia studies →The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 250 studies on the registry; 147 are open to participants now.
Compared within Gynatresia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Atrophy. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
AD-SVF intrauterine infusion therapy
Biological: AD-SVF
AD-SVF is isolated and extracted from adipose tissue for intrauterine infusion therapy.
Proportion of patients with endometrial thickness of 6 mm or greater
During the late proliferative phase, the endometrial thickness between anterior and posterior uterine walls is measured to be at least 6 mm through a median sagittal section of the uterus at least once.
Time frame: 6 months after AD-SVF intrauterine infusion therapy
Menstrual flow score at the 2nd month post-treatment
2 months after treatment, menstrual flow is scored according to the Pictorial Blood-loss Assessment Chart, with scores ranging from 0 to 100, and higher scores indicate better outcomes.
Time frame: 2 months after AD-SVF intrauterine infusion therapy
Menstrual flow score at the 6th month post-treatment
6 months after treatment, menstrual flow is scored according to the Pictorial Blood-loss Assessment Chart, with scores ranging from 0 to 100, and higher scores indicate better outcomes.
Time frame: 6 months after AD-SVF intrauterine infusion therapy
Chemical pregnancy
Serum β-HCG ≥ 10 mIU/mL is detected at least 30 days after menstruation.
Time frame: 9 months after AD-SVF intrauterine infusion therapy
Clinical pregnancy
Ultrasound indicates the presence of a gestational sac and fetal heartbeat in the uterine cavity Ultrasound indicates the presence of a gestational sac and fetal heartbeat in the uterine cavity Ultrasound indicates the presence of a gestational sac and fetal heartbeat in the uterine cavity at 6-8 weeks of gestation.
Time frame: 9 months after AD-SVF intrauterine infusion therapy
Start is estimated for Nov 2025; primary completion for Dec 2026, 13 months later.
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School →