An interventional study of Lower abdominal liposuction and preparation of SVF and Ovarian injection in Diminished Ovarian Reserve (DOR), sponsored by Peking University Third Hospital. Not yet recruiting at 4 sites in China. Open to female participants aged 20 Years to 39 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Treatment
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.
A multi-center, large-scale, prospective, randomized controlled clinical trial will enroll 260 patients diagnosed with DOR based on the inclusion and exclusion criteria from Peking University Third Hospital, Shanghai Zhongshan Hospital, General Hospital of Ningxia Medical University and The Third Affiliated Hospital of Guangzhou Medical University. 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 5 visits and 3 follow-up phone calls.
Peking University Third Hospital is the lead sponsor of 752 studies on the registry; 273 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Procedure: Lower abdominal liposuction and preparation of SVF · Procedure: Ovarian injection · Procedure: Conventional ART treatment · Drug: Hormone Replacement Therapy (HRT)
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.
Procedure: Conventional ART treatment · Drug: Hormone Replacement Therapy (HRT)
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.
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.
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.
Time frame: Within 6 months after treatment
Serum level of Anti-Mullerian hormone (AMH)
Independent sample t-test or non-parametric test will be used to compare and analyze AMH between the control group and the SVF group.
Time frame: 1 month, 3 months, and 6 months after treatment
Antral follicles count (AFC)
Independent sample t-test or non-parametric test will be used to compare and analyze AFC between the control group and the SVF group.
Time frame: 1 month, 3 months, and 6 months after treatment
Serum level of sex hormone (E2 and FSH)
Independent sample t-test or non-parametric test will be used to compare and analyze E2 and FSH between the control group and the SVF group.
Time frame: 1 month, 3 months, and 6 months after treatment
Ovarian volume
Ovarian volume will be recorded before and after the intervention. Changes in ovarian volume between the control group and the SVF group will be analyzed and compared using paired sample t-test or independent sample t-test. A change in ovarian volume is considered significant at p\<0.05.
Time frame: 1 month, 3 months, and 6 months after treatment
Menstrual status
The frequency, duration and volume of menses within 6months after the intervention will be recorded to evaluate whether the patient's menstrual status improved. The number of sanitary napkins needed will be used to approximate the menstrual volume. We define the recovery of menstrual status as the resumption of menstrual cycles (at least two consecutive uterine bleeds at an interval of 3-6 weeks) without any hormonal treatment, and normal menstruation duration and volume. This will be calculated as: menstrual recovery rate (%)=number of participants with menstrual recovery/total number of participants×100%.
Time frame: Within 6 months after treatment
Pregnancy outcomes
Live births or miscarriage of patients with successful pregnancy within 6months will be followed up. Live birth refers to the delivery of one or more viable fetus after 24 weeks of gestation. Miscarriage refers to a loss of pregnancy that occurs before 24 weeks of gestation. The rate of live birth will be calculated as: live birth rate (%)=number of participants with live births/total number of participants×100%. The rate of miscarriage will be calculated as: miscarriage rate (%)=number of participants with miscarriage/total number of participants×100%.
Time frame: Within 2 years after treatment
Health status of offspring
The health status (survival, physiological and intellectual development) of the offspring will also be recorded at the following follow-up times: 1 year, 1 year and 6 months, and 2 years after the intervention.
Time frame: 1 year, 1 year and 6 months, and 2 years after treatment
Adverse events (AEs)
The incidence of AEs will be calculated as: incidence of AEs (%)=number of participants with AEs/ total number of participants×100%. The gold standard for reporting AEs is the Common Terminology Criteria for Adverse Events version 5.0, which provides a standardized framework for evaluating the severity and impact of AE. Clinicians will interpret, diagnose and grade AEs using a scale from 1 to 5 over the duration of the trial: grade 1 (mild): asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; grade 2 (moderate): minimal, local or non-invasive intervention indicated, limiting age-appropriate instrumental activities of daily living (ADL); grade 3 (severe): severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care ADL; grade 4: life-threatening consequences, urgent intervention indicated; grade 5: death related to AE.
Time frame: Within 2 years after treatment
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2029, 37 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Peking University Third Hospital →