Endometrium; AtrophyPhase 1NCT07230600
AD-SVF Therapy for Refractory Endometrial Infertility
A Phase 1 study testing AD-SVF in people with Endometrium; Atrophy and Intrauterine Synechiae, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 to 45 years, women only
- Conditions the study is for
- Endometrium; Atrophy, Intrauterine Synechiae
- What is being tested?
- AD-SVF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Nov 2025to Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- refractory thin endometrium (endometrial thickness < 6 mm on the day of ovulation or the day of endometrial transformation during a hormone replacement cycle) and/or moderate to severe intrauterine adhesion；
- Inability to undergo autologous bone marrow stem cells-scaffold (BMSC) transplantation due to failed bone marrow aspiration, or lack of significant effect following the BMSC treatment;
- with fertility intentions;
- normal ovarian function or availability of cryopreserved embryos;
- 18kg/m^2 < body mass index (BMI) < 30kg/m^2;
Who cannot join
- Chromosomal karyotype abnormalities in one spouse;
- Severe endometriosis, uterine fibroids affecting the uterine cavity morphology, or uterine malformations;
- Abnormalities in coagulation function, hepatic or renal function, or other underlying conditions deemed by the investigator to potentially impact the study's progression (uncontrolled hypertension, diabetes, autoimmune diseases, etc.);
- Contraindications for pregnancy;
- Contraindications for hormonal cycle therapy;
- History of pelvic tumors;
- Simultaneous participation in other clinical studies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Yali Hu, 025-83106666 ext. 11201, glyyhuyali@163.com
About this study
Official title: Autologous Adipose-derived Stromal Vascular Fraction Therapy for Refractory Endometrial Infertility
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.
Read the detailed description
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.
- Conditions
- Endometrium; Atrophy, Intrauterine Synechiae
- Being tested
- AD-SVF
- Keywords
- adipose-derived stromal vascular fraction, thin endometrium
- Medical subject headings
- Atrophy, Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD-SVFBiological
AD-SVF is isolated and extracted from adipose tissue for intrauterine infusion therapy.
| Study group | Role | What they receive |
|---|---|---|
| AD-SVF therapy | Experimental | AD-SVF intrauterine infusion therapy Receives: Biological: AD-SVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after AD-SVF intrauterine infusion therapy
Secondary outcomes (4)
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.
Measured: 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.
Measured: 6 months after AD-SVF intrauterine infusion therapy
Chemical pregnancy
Serum β-HCG ≥ 10 mIU/mL is detected at least 30 days after menstruation.
Measured: 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.
Measured: 9 months after AD-SVF intrauterine infusion therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study startNov 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrium; AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yali Hu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Yali Hu, Principal investigator, The Affiliated Drum Tower Hospital of Nanjing UniversityHuiyan Wang, Principal investigator, The Affiliated Drum Tower Hospital of Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230600
- Sponsor's protocol ID
- SC2025-006-01
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Adipose-derived Stromal Vascular Fraction Therapy for Refractory Endometrial Infertility
- ClinicalTrials.gov ID
- NCT07230600
- Acronym / sponsor ID
- SC2025-006-01
- Conditions
- Endometrium; Atrophy, Intrauterine Synechiae
- Keywords
- adipose-derived stromal vascular fraction, thin endometrium
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AD-SVF therapy | Experimental | Biological: AD-SVFAD-SVF intrauterine infusion therapy |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- refractory thin endometrium (endometrial thickness < 6 mm on the day of ovulation or the day of endometrial transformation during a hormone replacement cycle) and/or moderate to severe intrauterine adhesion；
- Inability to undergo autologous bone marrow stem cells-scaffold (BMSC) transplantation due to failed bone marrow aspiration, or lack of significant effect following the BMSC treatment;
- with fertility intentions;
- normal ovarian function or availability of cryopreserved embryos;
- 18kg/m^2 < body mass index (BMI) < 30kg/m^2;
Key exclusion criteria (7 listed)
- Chromosomal karyotype abnormalities in one spouse;
- Severe endometriosis, uterine fibroids affecting the uterine cavity morphology, or uterine malformations;
- Abnormalities in coagulation function, hepatic or renal function, or other underlying conditions deemed by the investigator to potentially impact the study's progression (uncontrolled hypertension, diabetes, autoimmune diseases, etc.);
- Contraindications for pregnancy;
- Contraindications for hormonal cycle therapy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AD-SVFAD-SVF is isolated and extracted from adipose tissue for intrauterine infusion therapy. | Biological | AD-SVF therapy |
Primary outcome
Proportion of patients with endometrial thickness of 6 mm or greater
Time frame: 6 months after AD-SVF intrauterine infusion therapy
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.
4 secondary outcomes
Menstrual flow score at the 2nd month post-treatment
Time frame: 2 months after AD-SVF intrauterine infusion therapy
Menstrual flow score at the 6th month post-treatment
Time frame: 6 months after AD-SVF intrauterine infusion therapy
Chemical pregnancy
Time frame: 9 months after AD-SVF intrauterine infusion therapy
Clinical pregnancy
Time frame: 9 months after AD-SVF intrauterine infusion therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yali Hu principal investigator
The Affiliated Drum Tower Hospital of Nanjing University
Huiyan Wang principal investigator
The Affiliated Drum Tower Hospital of Nanjing University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AD-SVF in people with Endometrium; Atrophy and Intrauterine Synechiae, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yali Hu (86-025-83106666 ext. 11201, glyyhuyali@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with endometrial thickness of 6 mm or greater (time frame: 6 months after AD-SVF intrauterine infusion therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.