Diminished Ovarian Reserve (DOR)aSVF-DORNCT07901218
Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Diminished Ovarian Reserve
A study testing Lower abdominal liposuction and preparation of SVF, Ovarian injection and Conventional ART treatment in people with Diminished Ovarian Reserve (DOR), run by Peking University Third Hospital at 4 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Diminished Ovarian Reserve (DOR)
- What is being tested?
- Lower abdominal liposuction and preparation of SVF, Ovarian injection and Conventional ART treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 4 sitesChina
- Study dates
- 1 Nov 2026to 30 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women of childbearing age (20-39 years old) with fertility needs.
- The following conditions must be met simultaneously: ① Basal FSH > 10 IU/L (measured on days 2-4 of menstruation); ② Total number of bilateral AFC < 5 (by transvaginal ultrasound, measured on days 2-4 of menstruation); ③ AMH < 1.2 ng/mL.
- Previous controlled ovarian stimulation resulted in no more than 3 retrieved oocytes and/or no viable embryos for transfer and/or more than 2 previous embryo transfer failures; or previous inability to enter the ovarian stimulation cycle due to FSH levels ≥ 20 IU/L.
- The uterus and both ovaries are present, and the informed consent form is signed.
Who cannot join
- Suffering from autoimmune diseases or other endocrine disorders and the conditions are not under control;
- Having a history of gynecological malignant tumors or radiotherapy and chemotherapy; having malignant tumors in the adnexal area, or having a mass with an unclear benign or malignant nature; having a family history of gynecological malignant tumors;
- Having a history of venous thrombosis or pulmonary embolism;
- Having a history of malignant tumors, acute or chronic infectious diseases, hematological diseases or other diseases that affect the removal of fat during surgery and ovarian injection;
- Having serious diseases that are not suitable for pregnancy and have been judged by the investigator to potentially affect the efficacy or safety evaluation, such as circulatory system diseases, urinary system diseases, digestive system diseases, endocrine system diseases, respiratory system diseases, immune system diseases, mental or neurological diseases, etc.;
- Using systemic glucocorticoids or other immunosuppressants continuously for ≥ 3 weeks within 6 months before administration, or using systemic glucocorticoids (prednisone ≥ 20mg/d or equivalent dose) or other immunosuppressants within 3 days before administration.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Yaodong Zhang, Bachelor contact
China4 sites
Peking University Third Hospital
Beijing
Rui Yang, M.D., +86-010-82265080, yrjeff@126.com
Yaodong Zhang, Bachelor, zyddoctor99@163.com
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Bei Xu, M.D., +86 13659863501, bei_bei81@126.com
General Hospital of Ningxia Medical University
Ningxia
Rong Hu, M.D., +86 13895078588, hur@nyfy.com.cn
Shanghai Zhongshan Hospital
Shanghai
Liangshan Mu, M.D., +86 18817821283, mu.liangshan@zs-hospital.sh.cn
About this study
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.
Read the detailed description
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.
- Conditions
- Diminished Ovarian Reserve (DOR)
- Being tested
- Lower abdominal liposuction and preparation of SVF, Ovarian injection, Conventional ART treatment, Hormone Replacement Therapy (HRT)
- Keywords
- Female fertility, Diminished ovarian reserve, Adipose stromal vascular fraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower abdominal liposuction and preparation of SVFProcedure or surgery
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.
Ovarian injectionProcedure or surgery
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 ART treatmentProcedure or surgery
Conventional assisted reproductive technology (ART) treatment including in vitro fertilisation and embryo transfer (IVF-ET) and intracytoplasmic sperm injection (ICSI) ; Standard assisted reproductive treatments.
Hormone Replacement Therapy (HRT)Drug
Also called HRT
If necessary, oral administration of hormones such as Fenbolone can be given for replacement therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. In addition, if necessary, oral administration of hormones such as Fenbolone can be given for replacement therapy. Receives: Procedure: Lower abdominal liposuction and preparation of SVF; Procedure: Ovarian injection; Procedure: Conventional ART treatment; Drug: Hormone Replacement Therapy (HRT) |
| Group B-Control group | Active comparator | 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. Receives: Procedure: Conventional ART treatment; Drug: Hormone Replacement Therapy (HRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 6 months after treatment
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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%.
Measured: 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%.
Measured: 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.
Measured: 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.
Measured: Within 2 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diminished Ovarian Reserve (DOR)Studies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants will be randomized to two groups at a ratio of 1:1- SVF protocol, and conventional protocol.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, General Hospital of Ningxia Medical University, The Third Affiliated Hospital of Guangzhou Medical University
- Responsible party
- Principal investigator, Rui Yang, Peking University Third Hospital
- Investigators
- Rui Yang, M.D., Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901218
- Sponsor's protocol ID
- SVF2024-2-40911
- Acronym
- aSVF-DOR
- Status last verified
- Nov 2026
- First submitted
- 22 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Diminished Ovarian Reserve
- ClinicalTrials.gov ID
- NCT07901218
- Acronym / sponsor ID
- aSVF-DOR / SVF2024-2-40911
- Conditions
- Diminished Ovarian Reserve (DOR)
- Keywords
- Female fertility, Diminished ovarian reserve, Adipose stromal vascular fraction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, General Hospital of Ningxia Medical University, The Third Affiliated Hospital of Guangzhou Medical University
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible participants will be randomized to two groups at a ratio of 1:1- SVF protocol, and conventional protocol.
| Arm | Type | Receives |
|---|---|---|
| Group A-SVF group | Experimental | 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 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. |
| Group B-Control group | Active comparator | 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. |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women of childbearing age (20-39 years old) with fertility needs.
- The following conditions must be met simultaneously: ① Basal FSH > 10 IU/L (measured on days 2-4 of menstruation); ② Total number of bilateral AFC < 5 (by transvaginal ultrasound, measured on days 2-4 of menstruation); ③ AMH < 1.2 ng/mL.
- Previous controlled ovarian stimulation resulted in no more than 3 retrieved oocytes and/or no viable embryos for transfer and/or more than 2 previous embryo transfer failures; or previous inability to enter the ovarian stimulation cycle due to FSH levels ≥ 20 IU/L.
- The uterus and both ovaries are present, and the informed consent form is signed.
Key exclusion criteria (6 listed)
- Suffering from autoimmune diseases or other endocrine disorders and the conditions are not under control;
- Having a history of gynecological malignant tumors or radiotherapy and chemotherapy; having malignant tumors in the adnexal area, or having a mass with an unclear benign or malignant nature; having a family history of gynecological malignant tumors;
- Having a history of venous thrombosis or pulmonary embolism;
- Having a history of malignant tumors, acute or chronic infectious diseases, hematological diseases or other diseases that affect the removal of fat during surgery and ovarian injection;
- Having serious diseases that are not suitable for pregnancy and have been judged by the investigator to potentially affect the efficacy or safety evaluation, such as circulatory system diseases, urinary system diseases, digestive system diseases, endocrine system diseases, respiratory system diseases, immune system diseases, mental or neurological diseases, etc.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lower abdominal liposuction and preparation of SVFAfter 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. | Procedure or surgery | Group A-SVF group |
| Ovarian injectionUnder 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. | Procedure or surgery | Group A-SVF group |
| Conventional ART treatmentConventional assisted reproductive technology (ART) treatment including in vitro fertilisation and embryo transfer (IVF-ET) and intracytoplasmic sperm injection (ICSI) ; Standard assisted reproductive treatments. | Procedure or surgery | Group A-SVF group, Group B-Control group |
| Hormone Replacement Therapy (HRT)Also: HRTIf necessary, oral administration of hormones such as Fenbolone can be given for replacement therapy. | Drug | Group A-SVF group, Group B-Control group |
Primary outcome
The cumulative clinical pregnancy rate within 6 months in women with DOR undergoing IVF
Time frame: Within 6 months after treatment
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.
8 secondary outcomes
Serum level of Anti-Mullerian hormone (AMH)
Time frame: 1 month, 3 months, and 6 months after treatment
Antral follicles count (AFC)
Time frame: 1 month, 3 months, and 6 months after treatment
Serum level of sex hormone (E2 and FSH)
Time frame: 1 month, 3 months, and 6 months after treatment
Ovarian volume
Time frame: 1 month, 3 months, and 6 months after treatment
Menstrual status
Time frame: Within 6 months after treatment
Pregnancy outcomes
Time frame: Within 2 years after treatment
Health status of offspring
Time frame: 1 year, 1 year and 6 months, and 2 years after treatment
Adverse events (AEs)
Time frame: Within 2 years after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yaodong Zhang, Bachelor contact
Rui Yang, M.D. study director
Peking University Third Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower abdominal liposuction and preparation of SVF, Ovarian injection and Conventional ART treatment in people with Diminished Ovarian Reserve (DOR), run by Peking University Third Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rui Yang, M.D. (+86-010-82265080, yrjeff@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cumulative clinical pregnancy rate within 6 months in women with DOR undergoing IVF (time frame: Within 6 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.