Preimplantation genetic testing for aneuploidy in severe male factor infertility: protocol for a multicenter randomised controlled trial
Introduction Conventional intracytoplasmic sperm injection (ICSI) is a widely used treatment for couples with severe male infertility. However, there are controversies regarding the selection and the damage to gametes during the ICSI procedure. Although preimplantation genetic testing for aneuploidi...
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BMJ Publishing Group
2022-07-01
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| author | Li Wang Li Jin Yao Lu Chen Zhang He-Feng Huang Yun Sun Xian-hua Lin Meng-xi Guo Dan-dan Wu Jian-lin Zhang Cheng-liang Zhou Chen-ming Xu Song-chang Chen Song-ying Zhang Xiao-xi Sun Yan-ting Wu |
| author_facet | Li Wang Li Jin Yao Lu Chen Zhang He-Feng Huang Yun Sun Xian-hua Lin Meng-xi Guo Dan-dan Wu Jian-lin Zhang Cheng-liang Zhou Chen-ming Xu Song-chang Chen Song-ying Zhang Xiao-xi Sun Yan-ting Wu |
| author_sort | Li Wang |
| collection | DOAJ |
| description | Introduction Conventional intracytoplasmic sperm injection (ICSI) is a widely used treatment for couples with severe male infertility. However, there are controversies regarding the selection and the damage to gametes during the ICSI procedure. Although preimplantation genetic testing for aneuploidies (PGT-A) can give genetic information about embryos for transfer and improve fertility rate, and it is widely used in women with recurrent spontaneous abortion or advanced age, PGT-A is not only more expensive but also has unclear effectiveness with respect to the improvement of fertility rate among couples with severe male infertility. High-quality, well-powered randomised clinical trials (RCTs) comparing ICSI+PGT-A and ICSI are lacking.Methods and analysis This is a protocol for a multicenter, open-label RCT in four reproductive medical centers qualified for PGT technique in China. We will study couples with severe male infertility scheduled for their fertility treatment. After the blastocyst culture, eligible participants are randomised to the ICSI+PGT-A group or the conventional ICSI group in a 1:1 ratio. Other assisted reproductive procedures are similar and parallel between the two groups. The primary outcome will be live birth rate and cumulative live-birth rate . Secondary outcomes will be embryo implantation rate, biochemical pregnancy rate, clinical pregnancy rate, spontaneous abortion rate, ongoing pregnancy rate, preterm birth rate, fetal chromosomal abnormality rate, birth defect rate and treatment complications. To demonstrate or refute a difference between the two groups, we plan to include 188 participants in each group; taking consideration of 20% of dropout, the total target sample size is 450.Ethics and dissemination Ethical approval was obtained from International Peace Maternity and Child Health Hospital of Shanghai Jiao Tong University Medical Science Research Ethics Committee (GKLW2016-16). Informed consent will be obtained from each participant. The findings will be disseminated to the public through conference presentations and publication in peer-reviewed scientific journals.Trial registration number ClinicalTrials.gov, NCT02941965. |
| format | Article |
| id | doaj-art-66583479dccc4ca6bbdd9cdf14d044b9 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-66583479dccc4ca6bbdd9cdf14d044b92025-01-31T15:15:10ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2022-063030Preimplantation genetic testing for aneuploidy in severe male factor infertility: protocol for a multicenter randomised controlled trialLi Wang0Li Jin1Yao Lu2Chen Zhang3He-Feng Huang4Yun Sun5Xian-hua Lin6Meng-xi Guo7Dan-dan Wu8Jian-lin Zhang9Cheng-liang Zhou10Chen-ming Xu11Song-chang Chen12Song-ying Zhang13Xiao-xi Sun14Yan-ting Wu151Cleveland Clinic Lerner Research Institute, Cleveland, OH, USA1 State Key Laboratory of Genetic Engineering, Collaborative Innovation Center for Genetics and Development, School of Life Sciences, Fudan University, Shanghai, ChinaCenter for Reproductive Medicine, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China3 Lymphoma Diagnosis and Treatment Centre of Henan Province, Zhengzhou, Henan, ChinaResearch Units of Embryo Original Diseases, Chinese Academy of Medical Sciences, Beijing, ChinaCenter for Reproductive Medicine, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, ChinaInstitute of Reproduction and Development, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, ChinaSchool of Medicine, Shanghai Jiao Tong University, International Peace Maternity and Child Health Hospital, Shanghai, ChinaSchool of Medicine, Shanghai Jiao Tong University, International Peace Maternity and Child Health Hospital, Shanghai, ChinaInstitute of Reproduction and Development, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, ChinaReproductive Medical Center, International Peace Maternity and Child Health Hospital, Shanghai, ChinaInstitute of Reproduction and Development, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, ChinaInstitute of Reproduction and Development, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, ChinaSchool of Medicine Sir Run Run Shaw Hospital, Zhejiang University, Hangzhou, Zhejiang, ChinaReproductive Medical Center, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, ChinaInstitute of Reproduction and Development, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, ChinaIntroduction Conventional intracytoplasmic sperm injection (ICSI) is a widely used treatment for couples with severe male infertility. However, there are controversies regarding the selection and the damage to gametes during the ICSI procedure. Although preimplantation genetic testing for aneuploidies (PGT-A) can give genetic information about embryos for transfer and improve fertility rate, and it is widely used in women with recurrent spontaneous abortion or advanced age, PGT-A is not only more expensive but also has unclear effectiveness with respect to the improvement of fertility rate among couples with severe male infertility. High-quality, well-powered randomised clinical trials (RCTs) comparing ICSI+PGT-A and ICSI are lacking.Methods and analysis This is a protocol for a multicenter, open-label RCT in four reproductive medical centers qualified for PGT technique in China. We will study couples with severe male infertility scheduled for their fertility treatment. After the blastocyst culture, eligible participants are randomised to the ICSI+PGT-A group or the conventional ICSI group in a 1:1 ratio. Other assisted reproductive procedures are similar and parallel between the two groups. The primary outcome will be live birth rate and cumulative live-birth rate . Secondary outcomes will be embryo implantation rate, biochemical pregnancy rate, clinical pregnancy rate, spontaneous abortion rate, ongoing pregnancy rate, preterm birth rate, fetal chromosomal abnormality rate, birth defect rate and treatment complications. To demonstrate or refute a difference between the two groups, we plan to include 188 participants in each group; taking consideration of 20% of dropout, the total target sample size is 450.Ethics and dissemination Ethical approval was obtained from International Peace Maternity and Child Health Hospital of Shanghai Jiao Tong University Medical Science Research Ethics Committee (GKLW2016-16). Informed consent will be obtained from each participant. The findings will be disseminated to the public through conference presentations and publication in peer-reviewed scientific journals.Trial registration number ClinicalTrials.gov, NCT02941965.https://bmjopen.bmj.com/content/12/7/e063030.full |
| spellingShingle | Li Wang Li Jin Yao Lu Chen Zhang He-Feng Huang Yun Sun Xian-hua Lin Meng-xi Guo Dan-dan Wu Jian-lin Zhang Cheng-liang Zhou Chen-ming Xu Song-chang Chen Song-ying Zhang Xiao-xi Sun Yan-ting Wu Preimplantation genetic testing for aneuploidy in severe male factor infertility: protocol for a multicenter randomised controlled trial BMJ Open |
| title | Preimplantation genetic testing for aneuploidy in severe male factor infertility: protocol for a multicenter randomised controlled trial |
| title_full | Preimplantation genetic testing for aneuploidy in severe male factor infertility: protocol for a multicenter randomised controlled trial |
| title_fullStr | Preimplantation genetic testing for aneuploidy in severe male factor infertility: protocol for a multicenter randomised controlled trial |
| title_full_unstemmed | Preimplantation genetic testing for aneuploidy in severe male factor infertility: protocol for a multicenter randomised controlled trial |
| title_short | Preimplantation genetic testing for aneuploidy in severe male factor infertility: protocol for a multicenter randomised controlled trial |
| title_sort | preimplantation genetic testing for aneuploidy in severe male factor infertility protocol for a multicenter randomised controlled trial |
| url | https://bmjopen.bmj.com/content/12/7/e063030.full |
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