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Safety and Efficacy of Autologous Adipose-Derived Regenerative Cells (ADRCs) Injection for Improving Diminished Ovarian Reserve

NCT07117682 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-08-12

No results posted yet for this study

Summary

Diminished Ovarian Reserve (DOR) poses significant challenges to fertility and hormonal health, with limited effective treatments. This prospective, self-controlled clinical study evaluates the safety and efficacy of intraovarian injection of autologous Adipose-Derived Regenerative Cells (ADRCs) to improve ovarian function in reproductive-aged women with DOR.

The ARISE trail enrolled 25 women aged \<40 years meeting clinical criteria for DOR, excluding those with severe comorbidities. Autologous adipose tissue was harvested via liposuction, and ADRCs were isolated using the Celution® system before bilateral ovarian medulla injection. Participants underwent follow-up at multiple time points up to 12 months post-procedure.

Primary outcomes included cumulative clinical pregnancy rates (natural or via ART) within 12 months and 1-, 2-, 3-, 6-month changes in ovarian reserve markers (FSH, AMH, antral follicle count) in non-pregnant patients. Secondary outcomes encompassed ovarian reserve markers at 12 months, as well as menstrual pattern recovery and ovarian volume changes at 1, 2, 3, 6, 12 months. Adverse events (AEs) will be monitored at each time point.

Statistical analyses followed standard principles, including mixed models for repeated measures and appropriate tests for subgroup comparisons. Sample size was determined based on feasibility and prior effect size estimates to ensure adequate power.

This study provides novel insights into regenerative therapies for DOR, emphasizing safety and functional restoration.

Conditions

  • Diminished Ovarian Reserve (DOR)
  • Primary Ovarian Insufficiency (Poi)
  • Ovarian Failure, Premature

Interventions

DEVICE

Autologous Adipose-Derived Regenerative Cells (ADRCs) Intraovarian Injection

Under general anesthesia, patients undergo lower abdominal liposuction (aspirate: 100-360 mL). ADRCs are immediately prepared bedside using the Celution® system (Cytori Therapeutics): Lipoaspirate is processed in a sterile container with automated separation, centrifugation, and resuspension (90-120 min). From the 5mL ADRCs suspension obtained, 0.5mL is reserved for QC (cell count/viability/surface markers); 4.5mL is injected bilaterally into ovarian stroma (2-2.5mL/ovary). Post-procedure, patients are monitored supine for 30 min for local/systemic reactions before discharge if stable.

Sponsors & Collaborators

  • Peking University People's Hospital

    collaborator OTHER

  • Cytori Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-25
Primary Completion
2027-02-01
Completion
2027-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07117682 on ClinicalTrials.gov