Live birth after in vitro maturation versus standard in vitro fertilisation for women with polycystic ovary syndrome: protocol for a non-inferiority randomised clinical trial
Introduction Polycystic ovary syndrome (PCOS) is the first common cause of anovulatory infertility. Currently, in vitro fertilisation (IVF) is recommended when conventional attempts have failed. In vitro maturation (IVM) of human oocytes is an emerging treatment option in infertile women with PCOS....
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BMJ Publishing Group
2020-04-01
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| Series: | BMJ Open |
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| author | Jie Qiao Rui Wang Ben W Mol Rong Li Xiaoying Zheng Lin Zeng Lina Wang Danni Zheng Wei Guo Shuo Yang |
| author_facet | Jie Qiao Rui Wang Ben W Mol Rong Li Xiaoying Zheng Lin Zeng Lina Wang Danni Zheng Wei Guo Shuo Yang |
| author_sort | Jie Qiao |
| collection | DOAJ |
| description | Introduction Polycystic ovary syndrome (PCOS) is the first common cause of anovulatory infertility. Currently, in vitro fertilisation (IVF) is recommended when conventional attempts have failed. In vitro maturation (IVM) of human oocytes is an emerging treatment option in infertile women with PCOS. It is a patient-friendly intervention, avoiding the risk of ovarian hyperstimulation syndrome, which is a serious complication of controlled ovarian stimulation in the standard IVF procedure. We plan a randomised controlled trial (RCT) to evaluate whether IVM is non-inferior to the standard IVF for live birth in women with PCOS.Methods and analysis This is a single-centre, open-label, non-inferiority RCT performed in a large reproductive medicine centre in China. Infertile women with PCOS will be randomised to receive either IVM or standard IVF in a 1:1 treatment ratio after informed consent. IVF procedures used in our study are all standard treatments and other standard-assisted reproductive technologies will be similar between the two groups. The primary outcome is ongoing pregnancy leading to live birth within 6 months of the first oocyte retrieval cycle after randomisation. Pregnancy outcome, maternal safety and obstetric and perinatal complications will be secondary outcomes. The planned sample size is 350 (175 per group).Ethics and dissemination Ethical permission was acquired from the Ethics Committee of Peking University Third Hospital. The results will be issued to publications through scientific journals and conference reports.Trial registration number NCT03463772. |
| format | Article |
| id | doaj-art-0a72d69560bf414e8f16b0835a35e0d0 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-04-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-0a72d69560bf414e8f16b0835a35e0d02025-08-20T02:30:34ZengBMJ Publishing GroupBMJ Open2044-60552020-04-0110410.1136/bmjopen-2019-035334Live birth after in vitro maturation versus standard in vitro fertilisation for women with polycystic ovary syndrome: protocol for a non-inferiority randomised clinical trialJie Qiao0Rui Wang1Ben W Mol2Rong Li3Xiaoying Zheng4Lin Zeng5Lina Wang6Danni Zheng7Wei Guo8Shuo Yang9professor1 Department of Social Psychiatry, Affiliated Brain Hospital, Guangzhou Medical University, Guangzhou, Guangdong, ChinaOB/GYN, School of Medicine, Monash University, Clayton VIC, Victoria, Australia1 Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, People`s Republic of ChinaDepartment of Population Health and Aging Science, School of Population Medicine and Public Health, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, ChinaClinical Epidemiology Research Center, Peking University Third Hospital, Beijing, ChinaDepartment of Neurology, Taikang Xianlin Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, ChinaCenter for Reproductive Medicine, Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, ChinaDepartment of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People`s Republic of ChinaCenter of Oral Implantology, Stomatological Hospital, School of Stomatology, Southern Medical University, Guangzhou, ChinaIntroduction Polycystic ovary syndrome (PCOS) is the first common cause of anovulatory infertility. Currently, in vitro fertilisation (IVF) is recommended when conventional attempts have failed. In vitro maturation (IVM) of human oocytes is an emerging treatment option in infertile women with PCOS. It is a patient-friendly intervention, avoiding the risk of ovarian hyperstimulation syndrome, which is a serious complication of controlled ovarian stimulation in the standard IVF procedure. We plan a randomised controlled trial (RCT) to evaluate whether IVM is non-inferior to the standard IVF for live birth in women with PCOS.Methods and analysis This is a single-centre, open-label, non-inferiority RCT performed in a large reproductive medicine centre in China. Infertile women with PCOS will be randomised to receive either IVM or standard IVF in a 1:1 treatment ratio after informed consent. IVF procedures used in our study are all standard treatments and other standard-assisted reproductive technologies will be similar between the two groups. The primary outcome is ongoing pregnancy leading to live birth within 6 months of the first oocyte retrieval cycle after randomisation. Pregnancy outcome, maternal safety and obstetric and perinatal complications will be secondary outcomes. The planned sample size is 350 (175 per group).Ethics and dissemination Ethical permission was acquired from the Ethics Committee of Peking University Third Hospital. The results will be issued to publications through scientific journals and conference reports.Trial registration number NCT03463772.https://bmjopen.bmj.com/content/10/4/e035334.full |
| spellingShingle | Jie Qiao Rui Wang Ben W Mol Rong Li Xiaoying Zheng Lin Zeng Lina Wang Danni Zheng Wei Guo Shuo Yang Live birth after in vitro maturation versus standard in vitro fertilisation for women with polycystic ovary syndrome: protocol for a non-inferiority randomised clinical trial BMJ Open |
| title | Live birth after in vitro maturation versus standard in vitro fertilisation for women with polycystic ovary syndrome: protocol for a non-inferiority randomised clinical trial |
| title_full | Live birth after in vitro maturation versus standard in vitro fertilisation for women with polycystic ovary syndrome: protocol for a non-inferiority randomised clinical trial |
| title_fullStr | Live birth after in vitro maturation versus standard in vitro fertilisation for women with polycystic ovary syndrome: protocol for a non-inferiority randomised clinical trial |
| title_full_unstemmed | Live birth after in vitro maturation versus standard in vitro fertilisation for women with polycystic ovary syndrome: protocol for a non-inferiority randomised clinical trial |
| title_short | Live birth after in vitro maturation versus standard in vitro fertilisation for women with polycystic ovary syndrome: protocol for a non-inferiority randomised clinical trial |
| title_sort | live birth after in vitro maturation versus standard in vitro fertilisation for women with polycystic ovary syndrome protocol for a non inferiority randomised clinical trial |
| url | https://bmjopen.bmj.com/content/10/4/e035334.full |
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