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
Introduction Premature ovarian insufficiency (POI) is a complicated reproductive endocrine disease seriously affecting physiological function and fertility in women. Its clinical features include amenorrhoea or infrequent menstruation, oestrogen deficiency and elevated levels of gonadotropins. At pr...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2025-04-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/4/e093804.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849766636898222080 |
|---|---|
| author | Jie Qiao Hui Liu Rong Li Tian Tian Yang Yu Chen Zhang Ping Liu Lin Zeng Rui Yang Jia Li Shuo Yang Jialin Li Qing Guo Hongxia Zhang Caihong Ma Xiaojuan Liu Xiumei Zhen Yaodong Zhang Yanru Lou Chenhong Liu Wan Yang Huiyu Xu Hongsen Bi |
| author_facet | Jie Qiao Hui Liu Rong Li Tian Tian Yang Yu Chen Zhang Ping Liu Lin Zeng Rui Yang Jia Li Shuo Yang Jialin Li Qing Guo Hongxia Zhang Caihong Ma Xiaojuan Liu Xiumei Zhen Yaodong Zhang Yanru Lou Chenhong Liu Wan Yang Huiyu Xu Hongsen Bi |
| author_sort | Jie Qiao |
| collection | DOAJ |
| description | Introduction Premature ovarian insufficiency (POI) is a complicated reproductive endocrine disease seriously affecting physiological function and fertility in women. Its clinical features include amenorrhoea or infrequent menstruation, oestrogen deficiency and elevated levels of gonadotropins. At present, conventional treatments for POI in clinical practice are unable to fundamentally improve ovarian function or solve fertility problems, and often have certain side effects. Adipose tissue-derived stromal vascular fraction (SVF) contains various cell types, including adipose-derived stem/stromal cells, stromal cells, endothelial cells, fibroblasts and macrophages. Recently, SVF has shown tremendous potential in treating many refractory diseases, offering a promising therapeutic option for improving ovarian function. Although SVF has shown therapeutic effects in animal models of POI, there is insufficient evidence demonstrating the efficacy and safety of autologous SVF in women with POI.Methods and analysis This study is a single-centre randomised controlled trial designed to explore the efficacy and safety of using autologous SVF in improving pregnancy outcomes in patients with infertility diagnosed with POI. A total of 308 women meeting the eligibility criteria will be randomly assigned in a 1:1 ratio to either the SVF group or the control group. The control group will receive conventional assisted reproductive technology treatment, including in vitro fertilisation, embryo transfer and intracytoplasmic sperm injection. In the SVF group, patients will undergo bilateral intraovarian injections of the SVF suspension under ultrasound guidance. Their in vitro fertilisation cycles will commence 4–8 weeks after SVF injection. The primary outcome of this trial is the cumulative clinical pregnancy rate within 6 months. Aside from this, secondary outcomes including menstrual volume and duration, ovarian volume, antral follicle count, and serum levels of anti-mullerian hormone and sex hormone (oestrogen and follicle-stimulating hormone) will be measured. All adverse events will be monitored and recorded within a 6-month follow-up period. Additionally, pregnancy outcomes and the health status of the offspring will be tracked through telephone follow-up for 2 years.Ethics and dissemination This trial has been reviewed and approved by the Ethics Committee of Peking University Third Hospital (approval number: IRB00006761-M2024330). We will ensure that each patient has signed informed consent before participation in the trial. The findings will be published in a peer-reviewed journal.Trial registration number NCT06481969. |
| format | Article |
| id | doaj-art-ed7c9ab7e53044ae84cdac250fd5e62f |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-ed7c9ab7e53044ae84cdac250fd5e62f2025-08-20T03:04:30ZengBMJ Publishing GroupBMJ Open2044-60552025-04-0115410.1136/bmjopen-2024-093804Efficacy and safety of autologous adipose tissue-derived stromal vascular fraction in patients with premature ovarian insufficiency: protocol for a single-centre randomised controlled trialJie Qiao0Hui Liu1Rong Li2Tian Tian3Yang Yu4Chen Zhang5Ping Liu6Lin Zeng7Rui Yang8Jia Li9Shuo Yang10Jialin Li11Qing Guo12Hongxia Zhang13Caihong Ma14Xiaojuan Liu15Xiumei Zhen16Yaodong Zhang17Yanru Lou18Chenhong Liu19Wan Yang20Huiyu Xu21Hongsen Bi222 National Clinical Research Center for Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China1 State Key Laboratory of Female Fertility Promotion, Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China1 State Key Laboratory of Female Fertility Promotion, Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China2 National Clinical Research Center for Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China1 State Key Laboratory of Female Fertility Promotion, Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China6 Department of Plastic Surgery, Peking University Third Hospital, Beijing, China2 National Clinical Research Center for Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China7 Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing, China1 State Key Laboratory of Female Fertility Promotion, Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China1 State Key Laboratory of Female Fertility Promotion, Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China1 State Key Laboratory of Female Fertility Promotion, Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China4 Beijing Key Laboratory of Reproductive Endocrinology and Assisted Reproductive Technology, Peking University Third Hospital, Beijing, China1 State Key Laboratory of Female Fertility Promotion, Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China1 State Key Laboratory of Female Fertility Promotion, Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China1 State Key Laboratory of Female Fertility Promotion, Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China1 State Key Laboratory of Female Fertility Promotion, Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China4 Beijing Key Laboratory of Reproductive Endocrinology and Assisted Reproductive Technology, Peking University Third Hospital, Beijing, China1 State Key Laboratory of Female Fertility Promotion, Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China1 State Key Laboratory of Female Fertility Promotion, Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China3 Key Laboratory of Assisted Reproduction (Peking University), Ministry of Education, Beijing, China1 State Key Laboratory of Female Fertility Promotion, Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China1 State Key Laboratory of Female Fertility Promotion, Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China6 Department of Plastic Surgery, Peking University Third Hospital, Beijing, ChinaIntroduction Premature ovarian insufficiency (POI) is a complicated reproductive endocrine disease seriously affecting physiological function and fertility in women. Its clinical features include amenorrhoea or infrequent menstruation, oestrogen deficiency and elevated levels of gonadotropins. At present, conventional treatments for POI in clinical practice are unable to fundamentally improve ovarian function or solve fertility problems, and often have certain side effects. Adipose tissue-derived stromal vascular fraction (SVF) contains various cell types, including adipose-derived stem/stromal cells, stromal cells, endothelial cells, fibroblasts and macrophages. Recently, SVF has shown tremendous potential in treating many refractory diseases, offering a promising therapeutic option for improving ovarian function. Although SVF has shown therapeutic effects in animal models of POI, there is insufficient evidence demonstrating the efficacy and safety of autologous SVF in women with POI.Methods and analysis This study is a single-centre randomised controlled trial designed to explore the efficacy and safety of using autologous SVF in improving pregnancy outcomes in patients with infertility diagnosed with POI. A total of 308 women meeting the eligibility criteria will be randomly assigned in a 1:1 ratio to either the SVF group or the control group. The control group will receive conventional assisted reproductive technology treatment, including in vitro fertilisation, embryo transfer and intracytoplasmic sperm injection. In the SVF group, patients will undergo bilateral intraovarian injections of the SVF suspension under ultrasound guidance. Their in vitro fertilisation cycles will commence 4–8 weeks after SVF injection. The primary outcome of this trial is the cumulative clinical pregnancy rate within 6 months. Aside from this, secondary outcomes including menstrual volume and duration, ovarian volume, antral follicle count, and serum levels of anti-mullerian hormone and sex hormone (oestrogen and follicle-stimulating hormone) will be measured. All adverse events will be monitored and recorded within a 6-month follow-up period. Additionally, pregnancy outcomes and the health status of the offspring will be tracked through telephone follow-up for 2 years.Ethics and dissemination This trial has been reviewed and approved by the Ethics Committee of Peking University Third Hospital (approval number: IRB00006761-M2024330). We will ensure that each patient has signed informed consent before participation in the trial. The findings will be published in a peer-reviewed journal.Trial registration number NCT06481969.https://bmjopen.bmj.com/content/15/4/e093804.full |
| spellingShingle | Jie Qiao Hui Liu Rong Li Tian Tian Yang Yu Chen Zhang Ping Liu Lin Zeng Rui Yang Jia Li Shuo Yang Jialin Li Qing Guo Hongxia Zhang Caihong Ma Xiaojuan Liu Xiumei Zhen Yaodong Zhang Yanru Lou Chenhong Liu Wan Yang Huiyu Xu Hongsen Bi 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/15/4/e093804.full |
| work_keys_str_mv | AT jieqiao efficacyandsafetyofautologousadiposetissuederivedstromalvascularfractioninpatientswithprematureovarianinsufficiencyprotocolforasinglecentrerandomisedcontrolledtrial AT huiliu efficacyandsafetyofautologousadiposetissuederivedstromalvascularfractioninpatientswithprematureovarianinsufficiencyprotocolforasinglecentrerandomisedcontrolledtrial AT rongli efficacyandsafetyofautologousadiposetissuederivedstromalvascularfractioninpatientswithprematureovarianinsufficiencyprotocolforasinglecentrerandomisedcontrolledtrial AT tiantian efficacyandsafetyofautologousadiposetissuederivedstromalvascularfractioninpatientswithprematureovarianinsufficiencyprotocolforasinglecentrerandomisedcontrolledtrial AT yangyu efficacyandsafetyofautologousadiposetissuederivedstromalvascularfractioninpatientswithprematureovarianinsufficiencyprotocolforasinglecentrerandomisedcontrolledtrial AT chenzhang efficacyandsafetyofautologousadiposetissuederivedstromalvascularfractioninpatientswithprematureovarianinsufficiencyprotocolforasinglecentrerandomisedcontrolledtrial AT pingliu efficacyandsafetyofautologousadiposetissuederivedstromalvascularfractioninpatientswithprematureovarianinsufficiencyprotocolforasinglecentrerandomisedcontrolledtrial AT linzeng efficacyandsafetyofautologousadiposetissuederivedstromalvascularfractioninpatientswithprematureovarianinsufficiencyprotocolforasinglecentrerandomisedcontrolledtrial AT ruiyang efficacyandsafetyofautologousadiposetissuederivedstromalvascularfractioninpatientswithprematureovarianinsufficiencyprotocolforasinglecentrerandomisedcontrolledtrial AT jiali efficacyandsafetyofautologousadiposetissuederivedstromalvascularfractioninpatientswithprematureovarianinsufficiencyprotocolforasinglecentrerandomisedcontrolledtrial AT shuoyang efficacyandsafetyofautologousadiposetissuederivedstromalvascularfractioninpatientswithprematureovarianinsufficiencyprotocolforasinglecentrerandomisedcontrolledtrial AT jialinli efficacyandsafetyofautologousadiposetissuederivedstromalvascularfractioninpatientswithprematureovarianinsufficiencyprotocolforasinglecentrerandomisedcontrolledtrial AT qingguo efficacyandsafetyofautologousadiposetissuederivedstromalvascularfractioninpatientswithprematureovarianinsufficiencyprotocolforasinglecentrerandomisedcontrolledtrial AT hongxiazhang efficacyandsafetyofautologousadiposetissuederivedstromalvascularfractioninpatientswithprematureovarianinsufficiencyprotocolforasinglecentrerandomisedcontrolledtrial AT caihongma efficacyandsafetyofautologousadiposetissuederivedstromalvascularfractioninpatientswithprematureovarianinsufficiencyprotocolforasinglecentrerandomisedcontrolledtrial AT xiaojuanliu efficacyandsafetyofautologousadiposetissuederivedstromalvascularfractioninpatientswithprematureovarianinsufficiencyprotocolforasinglecentrerandomisedcontrolledtrial AT xiumeizhen efficacyandsafetyofautologousadiposetissuederivedstromalvascularfractioninpatientswithprematureovarianinsufficiencyprotocolforasinglecentrerandomisedcontrolledtrial AT yaodongzhang efficacyandsafetyofautologousadiposetissuederivedstromalvascularfractioninpatientswithprematureovarianinsufficiencyprotocolforasinglecentrerandomisedcontrolledtrial AT yanrulou efficacyandsafetyofautologousadiposetissuederivedstromalvascularfractioninpatientswithprematureovarianinsufficiencyprotocolforasinglecentrerandomisedcontrolledtrial AT chenhongliu efficacyandsafetyofautologousadiposetissuederivedstromalvascularfractioninpatientswithprematureovarianinsufficiencyprotocolforasinglecentrerandomisedcontrolledtrial AT wanyang efficacyandsafetyofautologousadiposetissuederivedstromalvascularfractioninpatientswithprematureovarianinsufficiencyprotocolforasinglecentrerandomisedcontrolledtrial AT huiyuxu efficacyandsafetyofautologousadiposetissuederivedstromalvascularfractioninpatientswithprematureovarianinsufficiencyprotocolforasinglecentrerandomisedcontrolledtrial AT hongsenbi efficacyandsafetyofautologousadiposetissuederivedstromalvascularfractioninpatientswithprematureovarianinsufficiencyprotocolforasinglecentrerandomisedcontrolledtrial |