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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AD-SVF therapy | Experimental | AD-SVF intrauterine infusion therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AD-SVF | Biological | AD-SVF is isolated and extracted from adipose tissue for intrauterine infusion therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months after AD-SVF intrauterine infusion therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 months after AD-SVF intrauterine infusion therapy |
| Menstrual flow score at the 6th month post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yali Hu | Contact | 86-025-83106666 | 11201 | glyyhuyali@163.com |
| Hui Zhu | Contact | 86-025-83106666 | 54330 | zhuhui1231@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Yali Hu | The Affiliated Drum Tower Hospital of Nanjing University | Principal Investigator |
| Huiyan Wang | The Affiliated Drum Tower Hospital of Nanjing University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Drum Tower Hospital | Recruiting | Nanjing | Jiangsu | 210008 | China |
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| ID | Term |
|---|---|
| D001284 | Atrophy |
| D006175 | Gynatresia |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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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. |
| 6 months after AD-SVF intrauterine infusion therapy |
| Chemical pregnancy | Serum β-HCG ≥ 10 mIU/mL is detected at least 30 days after menstruation. | 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. | 9 months after AD-SVF intrauterine infusion therapy |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |