Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Premature Ovarian Insufficiency (aSVF-POI)

November 12, 2024 updated by: Rui Yang
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A single-center, large-scale, prospective, randomized controlled clinical trial will enroll 260 patients diagnosed with POI based on the inclusion and exclusion criteria from Peking University Third Hospital. Eligible participants will be randomized to two groups at a ratio of 1:1- SVF protocol, and conventional protocol.The participation in this study will be approximately 2 years with a total of 6 visits and 3 follow-up phone calls.

Study Type

Interventional

Enrollment (Estimated)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Rui Yang, M.D.
  • Phone Number: +86-010-82265080
  • Email: yrjeff@126.com

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:
        • Contact:
          • Jia Li, M.D.
        • Contact:
        • Contact:
          • Xiumei Zhen, M.D.
        • Contact:
          • Hongsen Bi, M.D.
        • Contact:
          • Xiaojuan Liu, M.D.
        • Contact:
          • Tian Tian, M.D.
        • Contact:
          • Yanru Lou, Bachelor
        • Contact:
          • Chenhong Liu, Bachelor
        • Contact:
          • Jialin Li, Bachelor
        • Contact:
          • Lina Yi, Bachelor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A-SVF group
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
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.
Procedure: Ovarian injection
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.
Other: Group B-Control group
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
Conventional In Vitro Fertilization (IVF) procedure and standard assisted reproductive treatments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The cumulative clinical pregnancy rate in half a year
Time Frame: half a year after treatment
Percentage of patients with clinical pregnancy within half a year after treatment
half a year after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum level of Anti-Mullerian hormone (AMH)
Time Frame: half a year after treatment
Efficacy rate (%) = The number of patients with two consecutive increases in serum level of AMH after treatment / total number of included patients×100%
half a year after treatment
Antral follicles count (AFC)
Time Frame: half a year after treatment
Efficacy rate (%) = The number of patients with bilateral ovarian AFC increases by at least 2 after treatment / total number of included patients×100%
half a year after treatment
Serum level of sex hormone (E2 and FSH)
Time Frame: half a year after treatment
Efficacy rate (%) = The number of patients with two consecutive increases/decreases in serum level of E2/FSH after treatment / total number of included patients×100%
half a year after treatment
Ovarian volume
Time Frame: half a year after treatment
Ovarian volume will be recorded before and after treatment. Paired sample t-test or independent sample t-test will be used to compare the changes in ovarian volume between the control and SVF treatment groups, P < 0.05 will be recorded as significant change in ovarian volume.
half a year after treatment
Menstrual status
Time Frame: half a year after treatment
The frequency, duration and volume of menses within half a year after treatment will be recorded to evaluate whether the menstrual status of patients have improved. Menstrual recovery rate (%) = The number of patients with menstrual recovery after treatment / total number of included patients × 100%.
half a year after treatment
Pregnancy outcome
Time Frame: 2 years after treatment
Live births or miscarriage of patients with successful pregnancy within half a year will be followed up. Live birth defined as the delivery of at least one viable fetus after 24 weeks gestation. Miscarriage defined as a loss of pregnancy before 24 weeks gestation. Live birth rate (%) = The number of patients with live births after treatment / total number of included patients×100%. Miscarriage rate (%) = The number of patients with miscarriage after treatment / total number of included patients×100%.
2 years after treatment
Health status of offspring
Time Frame: 2 years after treatment
The health status (survival, physiological and intellectual development) of offspring will be followed up via telephone for 2 years.
2 years after treatment
Adverse reactions
Time Frame: 2 years after treatment
The frequency, date of onset, duration and severity of any local and systemic adverse reactions will be observed and recorded during the entire follow-up period. Incidence rate of adverse reactions (%) = The number of patients with adverse reactions after treatment / total number of included patients×100%.
2 years after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rui Yang

Investigators

  • Study Director: Rui Yang, M.D., Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

June 25, 2024

First Submitted That Met QC Criteria

June 25, 2024

First Posted (Actual)

July 1, 2024

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 12, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SF2024-2-40911

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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