Premature Ovarian InsufficiencyaSVF-POINCT06481969
Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Premature Ovarian Insufficiency
A study testing Conventional IVF, Lower abdominal liposuction and preparation of SVF and Ovarian injection in people with Premature Ovarian Insufficiency, run by Rui Yang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Premature Ovarian Insufficiency
- What is being tested?
- Conventional IVF, Lower abdominal liposuction and preparation of SVF and Ovarian injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 23 Jul 2024to 30 Dec 2026
- 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 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yaodong Zhang, Bachelor contact
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Rui Yang, M.D., +86-010-82265080, yrjeff@126.com
Yaodong Zhang, Bachelor, zyddoctor99@163.com
About this study
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.
Read the 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.
- Conditions
- Premature Ovarian Insufficiency
- Being tested
- Conventional IVF, Lower abdominal liposuction and preparation of SVF, Ovarian injection
- Keywords
- Female fertility, Premature Ovarian Insufficiency, Adipose stromal vascular fraction
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional IVFProcedure or surgery
Conventional In Vitro Fertilization (IVF) procedure and standard assisted reproductive treatments.
Lower abdominal liposuction and preparation of SVFProcedure or surgery
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.
Ovarian injectionProcedure or surgery
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.
| 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. Receives: 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. Receives: Procedure: Conventional IVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cumulative clinical pregnancy rate in half a year
Percentage of patients with clinical pregnancy within half a year after treatment
Measured: half a year after treatment
Secondary outcomes (8)
Serum level of Anti-Mullerian hormone (AMH)
Efficacy rate (%) = The number of patients with two consecutive increases in serum level of AMH after treatment / total number of included patients×100%
Measured: half a year after treatment
Antral follicles count (AFC)
Efficacy rate (%) = The number of patients with bilateral ovarian AFC increases by at least 2 after treatment / total number of included patients×100%
Measured: half a year after treatment
Serum level of sex hormone (E2 and FSH)
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%
Measured: half a year after treatment
Ovarian volume
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.
Measured: half a year after treatment
Menstrual status
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%.
Measured: half a year after treatment
Pregnancy outcome
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%.
Measured: 2 years after treatment
Health status of offspring
The health status (survival, physiological and intellectual development) of offspring will be followed up via telephone for 2 years.
Measured: 2 years after treatment
Adverse reactions
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%.
Measured: 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 posted1 Jul 2024
- Study start23 Jul 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature Ovarian InsufficiencyStudies of the same condition, open and under way.
- 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
- Rui Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-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
- NCT06481969
- Sponsor's protocol ID
- SF2024-2-40911
- Acronym
- aSVF-POI
- Status last verified
- Nov 2024
- First submitted
- 25 Jun 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40180397
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. 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 Premature Ovarian Insufficiency
- ClinicalTrials.gov ID
- NCT06481969
- Acronym / sponsor ID
- aSVF-POI / SF2024-2-40911
- Conditions
- Premature Ovarian Insufficiency
- Keywords
- Female fertility, Premature Ovarian Insufficiency, Adipose stromal vascular fraction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Rui YangUniversity, hospital or other
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 1 Jul 2024 (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 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.
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 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 injectionQualified 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. |
| Group B-Control group | Other | Procedure: Conventional IVFQualified 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. |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Conventional IVFConventional In Vitro Fertilization (IVF) procedure and standard assisted reproductive treatments. | Procedure or surgery | Group B-Control group |
| Lower abdominal liposuction and preparation of SVFAfter 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 or surgery | Group A-SVF group |
| Ovarian injectionUnder 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. | Procedure or surgery | Group A-SVF group |
Primary outcome
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
8 secondary outcomes
Serum level of Anti-Mullerian hormone (AMH)
Time frame: half a year after treatment
Antral follicles count (AFC)
Time frame: half a year after treatment
Serum level of sex hormone (E2 and FSH)
Time frame: half a year after treatment
Ovarian volume
Time frame: half a year after treatment
Menstrual status
Time frame: half a year after treatment
Pregnancy outcome
Time frame: 2 years after treatment
Health status of offspring
Time frame: 2 years after treatment
Adverse reactions
Time frame: 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 14 Nov 2024.
- Derived from this study: PubMed 40180397Zhang 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.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional IVF, Lower abdominal liposuction and preparation of SVF and Ovarian injection in people with Premature Ovarian Insufficiency, run by Rui Yang at 1 site 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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 in half a year (time frame: half a year after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06481969, which also lists 1 linked publication.
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 14 Nov 2024.