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Recruiting NCT07230600

AD-SVF Therapy for Refractory Endometrial Infertility

Phase I Interventional Endometrium; Atrophy Intrauterine Synechiae

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AD-SVF.
Who it may be relevant to
Registry conditions: Endometrium; Atrophy, Intrauterine Synechiae. Basic parameters: 22 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Autologous Adipose-derived Stromal Vascular Fraction Therapy for Refractory Endometrial Infertility

Overview

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.

Interventions

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

Primary outcome measures

  • Proportion of patients with endometrial thickness of 6 mm or greater [Time frame: 6 months after AD-SVF intrauterine infusion therapy]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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;

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Nanjing Drum Tower Hospital — Nanjing

Identifiers

NCT: NCT07230600 · SC2025-006-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗