Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Premature Ovarian Insufficiency

NCT06481969 | Recruiting DMC

• 1 other identifier: SF2024-2-40911
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

A single-center, prospective, randomised controlled clinical trial (1:1 treatment ratio), designed to investigate the efficacy and safety of autologous SVF in improving the pregnancy outcome of infertile patients with POI.

Conditions

Premature Ovarian Insufficiency

Keywords

Female fertility; Premature Ovarian Insufficiency; Adipose stromal vascular fraction

Outcome Measures

Primary Outcomes (1)

• The cumulative clinical pregnancy rate in half a year

  Percentage of patients with clinical pregnancy within half a year after treatment

  half a year after treatment

Secondary Outcomes (8)

• Serum level of Anti-Mullerian hormone (AMH)

  half a year after treatment

• Antral follicles count (AFC)

  half a year after treatment

• Serum level of sex hormone (E2 and FSH)

  half a year after treatment

• Ovarian volume

  half a year after treatment

• Menstrual status

  half a year after treatment

Study Arms (2)

Group A-SVF group

EXPERIMENTAL

Qualified participants will be randomized into either of two groups. Participants in this group will undergo lower abdominal liposuction, preparation of SVF and ovarian injection, other standard assisted reproductive treatments are similar and parallel between two groups.

Procedure: Lower abdominal liposuction and preparation of SVF; Procedure: Ovarian injection

Group B-Control group

OTHER

Qualified participants will be randomized into either of two groups. Participants in this group will be treated according to the current clinical routine of the reproductive center, other standard assisted reproductive treatments are similar and parallel between two groups.

Procedure: Conventional IVF

Interventions

Conventional IVF PROCEDURE

Conventional In Vitro Fertilization (IVF) procedure and standard assisted reproductive treatments.

Group B-Control group

Lower abdominal liposuction and preparation of SVF PROCEDURE

After lower abdominal liposuction (the liposuction volume is about 100 ml), the preparation and quality inspection of SVF will be completed by a laboratory with good manufacturing practice-approved facilities immediately. The adipose tissue will be cut into pieces of about 1mm3, and the equal volume of 0.1% collagenase I will be added to digest the adipose tissue. The digestion will be terminated after 40 minutes, followed by isolation, filtration, centrifugation, resuspension and dilution to obtain the SVF suspension. The test items, including bacteria, fungi, viruses and endotoxin, will be tested, and the expression of SVF surface markers, including CD45, CD34, CD31, CD11b, CD44, CD73, CD105 and CD90, will be detected by flow cytometry to ensure the quality of the SVF suspension. After about 4 hours of quality control and detection, the SVF suspension will be transported to the operating room on ice in a sealed incubator.

Group A-SVF group

Ovarian injection PROCEDURE

Under ultrasound guidance, the SVF suspension will be injected into patients' bilateral ovaries. SVF with a total amount of (1\~2)×107 cells from autologous fat tissue will be transplanted into each side of ovary. There are 3 injection points on each side of ovary, and 330±10μl SVF suspension will be administered at each point. The administration volume of each ovary will be 1ml in total. After injection, the patients will be required to lie flat for 2 hours to observe whether there would be adverse events.

Group A-SVF group

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged ≥20 and ≤39 years who have childbearing requirements.
• Cessation of menstruation or oligomenorrhea for at least 4 months
• Serum level of basal follicle stimulating hormone (FSH) \>25 U/L at least 2 times (during the second to fourth day of the menstrual cycle or during amenorrhea; The interval between the two tests is 4 weeks)
• Serum level of Anti-Mullerian hormone (AMH) ≤1.1 ng/ml
• Women with intact uterus and bilateral adnexa.
• Voluntary participation and informed consent obtained.

You may not qualify if:

• Women with autoimmune diseases.
• Women with abnormal and uncontrolled thyroid function.
• Women with tumors in bilateral adnexa that are not clearly benign or malignant.
• Women with a history of malignant tumors, radiation therapy or chemotherapy.
• Women with a history of venous thrombosis or pulmonary embolism during the screening period.
• Women with severe illnesses that are not suitable for pregnancy, such as diseases of the circulatory system, urinary system, digestive system, endocrine system, respiratory system, immune system, mental or neurological system, etc.
• Women who continuously used systemic glucocorticoids or other immunosuppressants for≥3 weeks within 6 months before administration and women who used systemic glucocorticoids (prednisone≥20 mg/d or equivalent dose) or other immunosuppressants within 3 days before administration.
• Women who are allergic to the active ingredients or excipients of test drugs.
• Women with a family history of severe genetic diseases or gynecologic malignancies.

Sponsors & Collaborators

• Rui Yang: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Related Publications (1)

• Zhang Y, Liu H, Lou Y, Li J, Liu C, Zhang H, Zhang C, Guo Q, Liu X, Yang W, Li J, Tian T, Zeng L, Xu H, Yang S, Zhen X, Bi H, Yang R, Yu Y, Ma C, Li R, Liu P, Qiao J. Efficacy and safety of autologous adipose tissue-derived stromal vascular fraction in patients with premature ovarian insufficiency: protocol for a single-centre randomised controlled trial. BMJ Open. 2025 Apr 3;15(4):e093804. doi: 10.1136/bmjopen-2024-093804.

  PMID: 40180397 DERIVED

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 Officials

• Rui Yang, M.D.

  Peking University Third Hospital

  STUDY DIRECTOR

Central Study Contacts

Rui Yang, M.D.

CONTACT

+86-010-82265080; yrjeff@126.com

Yaodong Zhang, Bachelor

CONTACT

zyddoctor99@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the particularity of the treatment plan, the evaluator, namely the follow-up personnel who collect the postoperative medical history and the ultrasound evaluator, will be blinded in this trial to hide the grouping results. Blinding of participants and researchers is not possible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical associate professor

Model Details: Eligible participants will be randomized to two groups at a ratio of 1:1- SVF protocol, and conventional protocol.

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: July 23, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)