Letrozole ovulation regimen for frozen-thawed embryo transfer in women with polycystic ovary syndrome: a muti-centre randomised controlled trial
Abstract Background Polycystic ovary syndrome (PCOS) patients typically undergo either an ovulation induction regimen or a programmed regimen for endometrial preparation before frozen embryo transfer (FET). However, the superiority of one approach over the other remains controversial. While previous...
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BMC
2025-07-01
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| Series: | Reproductive Biology and Endocrinology |
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| Online Access: | https://doi.org/10.1186/s12958-025-01432-w |
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| author | Yanqiu Xie Ping Li Guimin Hao Weifen Deng Junli Zhao Shanshan Gao Bingbing Deng Yanping Li Min Deng Yingying Yuan Qi Fan Ningzhen Zhang Zhiming Zhao Yuhua Shi |
| author_facet | Yanqiu Xie Ping Li Guimin Hao Weifen Deng Junli Zhao Shanshan Gao Bingbing Deng Yanping Li Min Deng Yingying Yuan Qi Fan Ningzhen Zhang Zhiming Zhao Yuhua Shi |
| author_sort | Yanqiu Xie |
| collection | DOAJ |
| description | Abstract Background Polycystic ovary syndrome (PCOS) patients typically undergo either an ovulation induction regimen or a programmed regimen for endometrial preparation before frozen embryo transfer (FET). However, the superiority of one approach over the other remains controversial. While previous studies suggest that the letrozole regimen may improve pregnancy outcomes, prospective studies are insufficient. Therefore, we designed a multi-center randomized controlled trial to compare the pregnancy outcomes between these two regimens in PCOS patients undergoing FET. Methods This multicentre, randomised controlled, open-label trial included 155 PCOS patients from six hospitals in China between September 2022 and February 2024. Patients were randomised into either the letrozole ovulation regimen group (n = 81) or the programmed regimen group (n = 74) during FET cycles. Subgroup analysis was used among patients with single blastocyst transfer. The primary outcome was clinical pregnancy rate, with secondary outcomes including abortion rate, live birth rate, and other pregnancy and neonatal outcomes. Results Analysis of 155 FET women showed no significant difference in clinical pregnancy rates between the letrozole group (62.96%) and the programmed group (60.81%, P > 0.05). Similarly, no differences were observed in abortion rate, live birth rate, hypertensive disorders of pregnancy, gestational diabetes mellitus, preterm birth, or neonatal birth weight. However, more patients in the letrozole group received single-drug luteal support (53.16% vs. 16.67%, P < 0.05). A subgroup analysis of 108 women involving patients who underwent single blastocyst transfer revealed no significant differences in clinical pregnancy rates (66.67% vs. 73.33%, P > 0.05) or live birth rates (58.73% vs. 55.56%, P > 0.05) between the two groups. A higher proportion of women in the letrozole ovulation regimen group received single-drug luteal support compared to those in the programmed regimen group (58.73% vs. 22.22%, P < 0.05). No statistically significant differences were observed between the groups in terms of fertilization method, abortion rate, or obstetric and neonatal outcomes. Conclusions The letrozole ovulation regimen demonstrated comparable clinical pregnancy rates to the programmed regimen in PCOS patients undergoing FET, while requiring only simple luteal support. These findings suggest that the letrozole regimen may be a favourable alternative for endometrial preparation in this population. Trial registration Chinese Clinical Trial Registry ChiCTR2200062244 ( https://www.chictr.org.cn ). Registered on 31 July 2022. |
| format | Article |
| id | doaj-art-b964bce3147044faabfe53e26b2042dd |
| institution | Kabale University |
| issn | 1477-7827 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | BMC |
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| series | Reproductive Biology and Endocrinology |
| spelling | doaj-art-b964bce3147044faabfe53e26b2042dd2025-08-20T04:02:45ZengBMCReproductive Biology and Endocrinology1477-78272025-07-0123111010.1186/s12958-025-01432-wLetrozole ovulation regimen for frozen-thawed embryo transfer in women with polycystic ovary syndrome: a muti-centre randomised controlled trialYanqiu Xie0Ping Li1Guimin Hao2Weifen Deng3Junli Zhao4Shanshan Gao5Bingbing Deng6Yanping Li7Min Deng8Yingying Yuan9Qi Fan10Ningzhen Zhang11Zhiming Zhao12Yuhua Shi13Guangdong Provincial People’s Hospital (Guangdong Academy of Medical Sciences), Southern Medical UniversityDepartment of Reproductive Medicine, Women and Children’s Hospital, School of Medicine, Xiamen universityDepartment of Reproductive Medicine, the Second Hospital of Hebei Medical UniversityReproductive Medicine Center, Shenzhen Hengsheng HospitalReproductive Medicine Center, General Hospital of Ningxia Medical University, Ningxia Medical UniversityState Key Laboratory of Reproductive Medicine and Offspring Health, Center for Reproductive Medicine, Institute of Women, Children and Reproductive Health, Shandong UniversityDepartment of Reproductive Medicine, Women and Children’s Hospital, School of Medicine, Xiamen universityReproductive Medicine Center, Xiangya Hospital of Central South UniversityGuangdong Provincial People’s Hospital (Guangdong Academy of Medical Sciences), Southern Medical UniversityReproductive Medicine Center, General Hospital of Ningxia Medical University, Ningxia Medical UniversityGuangdong Provincial People’s Hospital (Guangdong Academy of Medical Sciences), Southern Medical UniversityDepartment of Obstetrics and Gynecology, Center for Reproductive Medicine, Nanfang Hospital, Southern Medical UniversityDepartment of Reproductive Medicine, the Second Hospital of Hebei Medical UniversityGuangdong Provincial People’s Hospital (Guangdong Academy of Medical Sciences), Southern Medical UniversityAbstract Background Polycystic ovary syndrome (PCOS) patients typically undergo either an ovulation induction regimen or a programmed regimen for endometrial preparation before frozen embryo transfer (FET). However, the superiority of one approach over the other remains controversial. While previous studies suggest that the letrozole regimen may improve pregnancy outcomes, prospective studies are insufficient. Therefore, we designed a multi-center randomized controlled trial to compare the pregnancy outcomes between these two regimens in PCOS patients undergoing FET. Methods This multicentre, randomised controlled, open-label trial included 155 PCOS patients from six hospitals in China between September 2022 and February 2024. Patients were randomised into either the letrozole ovulation regimen group (n = 81) or the programmed regimen group (n = 74) during FET cycles. Subgroup analysis was used among patients with single blastocyst transfer. The primary outcome was clinical pregnancy rate, with secondary outcomes including abortion rate, live birth rate, and other pregnancy and neonatal outcomes. Results Analysis of 155 FET women showed no significant difference in clinical pregnancy rates between the letrozole group (62.96%) and the programmed group (60.81%, P > 0.05). Similarly, no differences were observed in abortion rate, live birth rate, hypertensive disorders of pregnancy, gestational diabetes mellitus, preterm birth, or neonatal birth weight. However, more patients in the letrozole group received single-drug luteal support (53.16% vs. 16.67%, P < 0.05). A subgroup analysis of 108 women involving patients who underwent single blastocyst transfer revealed no significant differences in clinical pregnancy rates (66.67% vs. 73.33%, P > 0.05) or live birth rates (58.73% vs. 55.56%, P > 0.05) between the two groups. A higher proportion of women in the letrozole ovulation regimen group received single-drug luteal support compared to those in the programmed regimen group (58.73% vs. 22.22%, P < 0.05). No statistically significant differences were observed between the groups in terms of fertilization method, abortion rate, or obstetric and neonatal outcomes. Conclusions The letrozole ovulation regimen demonstrated comparable clinical pregnancy rates to the programmed regimen in PCOS patients undergoing FET, while requiring only simple luteal support. These findings suggest that the letrozole regimen may be a favourable alternative for endometrial preparation in this population. Trial registration Chinese Clinical Trial Registry ChiCTR2200062244 ( https://www.chictr.org.cn ). Registered on 31 July 2022.https://doi.org/10.1186/s12958-025-01432-wPolycystic ovary syndromeLetrozoleProgrammed regimenFrozen-embryo transferClinical pregnancy rate |
| spellingShingle | Yanqiu Xie Ping Li Guimin Hao Weifen Deng Junli Zhao Shanshan Gao Bingbing Deng Yanping Li Min Deng Yingying Yuan Qi Fan Ningzhen Zhang Zhiming Zhao Yuhua Shi Letrozole ovulation regimen for frozen-thawed embryo transfer in women with polycystic ovary syndrome: a muti-centre randomised controlled trial Reproductive Biology and Endocrinology Polycystic ovary syndrome Letrozole Programmed regimen Frozen-embryo transfer Clinical pregnancy rate |
| title | Letrozole ovulation regimen for frozen-thawed embryo transfer in women with polycystic ovary syndrome: a muti-centre randomised controlled trial |
| title_full | Letrozole ovulation regimen for frozen-thawed embryo transfer in women with polycystic ovary syndrome: a muti-centre randomised controlled trial |
| title_fullStr | Letrozole ovulation regimen for frozen-thawed embryo transfer in women with polycystic ovary syndrome: a muti-centre randomised controlled trial |
| title_full_unstemmed | Letrozole ovulation regimen for frozen-thawed embryo transfer in women with polycystic ovary syndrome: a muti-centre randomised controlled trial |
| title_short | Letrozole ovulation regimen for frozen-thawed embryo transfer in women with polycystic ovary syndrome: a muti-centre randomised controlled trial |
| title_sort | letrozole ovulation regimen for frozen thawed embryo transfer in women with polycystic ovary syndrome a muti centre randomised controlled trial |
| topic | Polycystic ovary syndrome Letrozole Programmed regimen Frozen-embryo transfer Clinical pregnancy rate |
| url | https://doi.org/10.1186/s12958-025-01432-w |
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