NCT07901218|Not Yet RecruitingDMC
Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Diminished Ovarian Reserve
aSVF-DOR
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aSVF-DOR
Sponsor study identifier
interventional
260
1 country
4
Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
A multi-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 DOR.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 22, 2026
Actual (reported)October 28, 2026
Actual (reported)November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The cumulative clinical pregnancy rate within 6 months in women with DOR undergoing IVF
This will be calculated as: cumulative clinical pregnancy rate (%)= number of participants obtain clinical pregnancy within 6 months / total number of participants×100%. Clinical pregnancy refers to the condition where ultrasound can detect one or more viable gestational sacs.
Within 6 months after treatment
Serum level of Anti-Mullerian hormone (AMH)
1 month, 3 months, and 6 months after treatment
Antral follicles count (AFC)
1 month, 3 months, and 6 months after treatment
Serum level of sex hormone (E2 and FSH)
1 month, 3 months, and 6 months after treatment
Ovarian volume
1 month, 3 months, and 6 months after treatment
Menstrual status
Within 6 months after treatment
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. In addition, if necessary, oral administration of hormones such as Fenbolone can be given for replacement therapy.
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. In addition, if necessary, oral administration of hormones such as Fenbolone can be given for replacement therapy.
After lower abdominal liposuction (the liposuction volume is about 200 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.
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Peking University Third Hospital
Beijing, China
Rui Yang, M.D.
Peking University Third Hospital
First Submitted
October 22, 2026
First Posted
October 28, 2026
Study Start
November 1, 2026
Under ultrasound guidance, the SVF suspension will be transplanted into the patient's bilateral ovaries by a reproductive endocrinologist. Briefly, both ovaries will be intramedullary injected on multiple sites using a 17-gauge single-lumen needle. A total of 1-2×107 cells from autologous adipose tissue will be injected into each ovary. Approximately 330±10µL of SVF suspension will be administered at each point, 1mL per ovary in total. Following the infusion procedure, the pelvis will be thoroughly examined via ultrasonography in order to check for total vascular integrity. Anaesthetic drugs will not be used during this procedure, but analgesics may be administered if necessary. After the injection, patients will be required to lie flat for 2h to monitor for any AEs.
Conventional assisted reproductive technology (ART) treatment including in vitro fertilisation and embryo transfer (IVF-ET) and intracytoplasmic sperm injection (ICSI) ; Standard assisted reproductive treatments.
If necessary, oral administration of hormones such as Fenbolone can be given for replacement therapy.
Contact the study team to confirm eligibility.
General Hospital of Ningxia Medical University
Ningxia, China
Shanghai Zhongshan Hospital
Shanghai, China
Planned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 28, 2026
Record last verified: 2026-10
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