NCT07230600

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
13mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress33%
Nov 2025Jun 2027

Study Start

First participant enrolled

November 1, 2025

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

1.1 years

First QC Date

November 13, 2025

Last Update Submit

November 14, 2025

Conditions

Endometrium; AtrophyIntrauterine Synechiae

Keywords

adipose-derived stromal vascular fractionthin endometrium

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Menstrual flow score at the 2nd month post-treatment

    2 months after AD-SVF intrauterine infusion therapy

  • Menstrual flow score at the 6th month post-treatment

    6 months after AD-SVF intrauterine infusion therapy

  • Chemical pregnancy

    9 months after AD-SVF intrauterine infusion therapy

  • Clinical pregnancy

    9 months after AD-SVF intrauterine infusion therapy

Study Arms (1)

AD-SVF therapy

EXPERIMENTAL

AD-SVF intrauterine infusion therapy

Biological: AD-SVF

Interventions

AD-SVFBIOLOGICAL

AD-SVF is isolated and extracted from adipose tissue for intrauterine infusion therapy.

AD-SVF therapy

Eligibility Criteria

Age22 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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;
  • kg/m\^2 \< body mass index (BMI) \< 30kg/m\^2;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

AtrophyGynatresia

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Yali Hu

    The Affiliated Drum Tower Hospital of Nanjing University

    PRINCIPAL INVESTIGATOR

  • Huiyan Wang

    The Affiliated Drum Tower Hospital of Nanjing University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yali Hu

CONTACT

86-025-83106666glyyhuyali@163.com

Hui Zhu

CONTACT

86-025-83106666zhuhui1231@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D.

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 17, 2025

Study Start

November 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

November 18, 2025

Record last verified: 2025-11

Locations

CN(1)