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

NCT07117682 | Not Yet Recruiting DMC

• 1 other identifier: ARISE-01
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Diminished Ovarian Reserve; Adipose-Derived Regenerative Cells; anti-Müllerian hormone; follicle-stimulating hormone; antral follicle count

Outcome Measures

Primary Outcomes (2)

• Cumulative Clinical Pregnancy Rate

  Cumulative Clinical Pregnancy Rate within 12 months post-treatment: Conception via natural pregnancy or assisted reproductive technology which is confirmed by fetal cardiac activity on ultrasound. Subgroup analysis will compare natural pregnancy with conception via assisted reproductive technology.

  12 months

• Change in Ovarian Reserve Markers for non-pregnant patients

  Measured at 1, 2, 3, and 6 months, with parameters assessed on menstrual days 2-5 including FSH, AMH and AFC. These will be analyzed using a repeated-measure mixed-effects model, with data censoring applied after pregnancy.

  1 month, 2 months, 3 months, 6 months

Secondary Outcomes (3)

• 12-Month Change in Ovarian Reserve Markers for non-pregnant patients

  12 months

• Menstrual Pattern Recovery for non-pregnant patients

  1 month, 2 months, 3 months, 6 months, 12 months

• Ovarian Volume Change for non-pregnant patients

  1 month, 2 months, 3 months, 6 months, 12 months

Other Outcomes (1)

• Safety endpoint

  12 months

Study Arms (1)

ADRCs group

EXPERIMENTAL

Device: Autologous Adipose-Derived Regenerative Cells (ADRCs) Intraovarian Injection

Interventions

Autologous Adipose-Derived Regenerative Cells (ADRCs) Intraovarian Injection DEVICE

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.

ADRCs group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients aged 20-39 years.
• Diagnosed with DOR, defined as AFC \< 7 and/or AMH ≤ 1.1 ng/mL.
• FSH ≤ 40 U/L.
• Have signed informed consent for the clinical trial.
• In good general health and able to tolerate local anesthesia, liposuction, oocyte retrieval, as well as pregnancy and childbirth.
• Without relative contraindications to fertility such as hereditary tumor-related diseases.

You may not qualify if:

• Presence of thyroid disorders.
• Body Mass Index (BMI) \< 18 kg/m².
• Confirmed pregnancy (positive β-hCG with ultrasound confirmation of embryo implantation).
• History of autoimmune diseases.
• Family history of ovarian tumors.
• Prior pelvic or systemic radiotherapy for cancer treatment.
• Positive serology/virology results for human immunodeficiency virus (HIV), Hepatitis C, Hepatitis B, Syphilis, human papillomavirus (HPV), or abnormal ThinPrep cytology (TCT).
• DOR caused by genetic disorders.
• Reproductive system pathologies including polycystic ovary syndrome (PCOS), adenomyosis, uterine fibroids ≥ 5 cm, endometrial carcinoma, or uterine malformations.
• Contraindications to liposuction.
• Abnormal semen analysis of the male partner precluding natural conception or conception via assisted reproductive technology (ART).
• Malignancy-related conditions such as active malignancy without complete remission or chemotherapy administration within the past 6 months.

Sponsors & Collaborators

• Cytori Therapeutics: lead
• Peking University People's Hospital: collaborator

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share