AD-SVF Therapy for Refractory Endometrial Infertility

November 14, 2025 updated by: Yali Hu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Nanjing Drum Tower Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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；
  2. 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;
  3. with fertility intentions;
  4. normal ovarian function or availability of cryopreserved embryos;
  5. 18kg/m^2 < body mass index (BMI) < 30kg/m^2;

Exclusion Criteria:

  1. Chromosomal karyotype abnormalities in one spouse;
  2. Severe endometriosis, uterine fibroids affecting the uterine cavity morphology, or uterine malformations;
  3. 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.);
  4. Contraindications for pregnancy;
  5. Contraindications for hormonal cycle therapy;
  6. History of pelvic tumors;
  7. Simultaneous participation in other clinical studies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AD-SVF therapy
AD-SVF intrauterine infusion therapy
Biological: AD-SVF
AD-SVF is isolated and extracted from adipose tissue for intrauterine infusion therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months after AD-SVF intrauterine infusion therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chemical pregnancy
Time Frame: 9 months after AD-SVF intrauterine infusion therapy
Serum β-HCG ≥ 10 mIU/mL is detected at least 30 days after menstruation.
9 months after AD-SVF intrauterine infusion therapy
Clinical pregnancy
Time Frame: 9 months after AD-SVF intrauterine infusion therapy
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
Menstrual flow score at the 2nd month post-treatment
Time Frame: 2 months after AD-SVF intrauterine infusion therapy
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
Time Frame: 6 months after AD-SVF intrauterine infusion therapy
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Investigators

  • Principal Investigator: Yali Hu, The Affiliated Drum Tower Hospital of Nanjing University
  • Principal Investigator: Huiyan Wang, The Affiliated Drum Tower Hospital of Nanjing University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

November 13, 2025

First Posted (Estimated)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SC2025-006-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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