Intracytoplasmic sperm injection (ICSI) versus conventional in vitro fertilisation (IVF) in couples with non-severe male infertility (NSMI-ICSI): protocol for a multicentre randomised controlled trial

Danni Zheng; Lin Zeng; Rui Yang; Ying Lian; Yi-Min Zhu; Xiaoyan Liang; Li Tang; Huichun Wang; Yunxia Cao; Guimin Hao; Jianqiao Liu; Junli Zhao; Rui Wang; Ben Willem Mol; Rong Li; He-Feng Huang; Jie Qiao

doi:10.1136/bmjopen-2019-030366

Intracytoplasmic sperm injection (ICSI) versus conventional in vitro fertilisation (IVF) in couples with non-severe male infertility (NSMI-ICSI): protocol for a multicentre randomised controlled trial

BMJ Open. 2019 Sep 30;9(9):e030366. doi: 10.1136/bmjopen-2019-030366.

Authors

Danni Zheng^{1

2

3

4

5

6}, Lin Zeng⁷, Rui Yang^{1

2

3

4

5

6}, Ying Lian^{1

2

3

4

5

6}, Yi-Min Zhu⁸, Xiaoyan Liang⁹, Li Tang¹⁰, Huichun Wang¹¹, Yunxia Cao¹², Guimin Hao¹³, Jianqiao Liu¹⁴, Junli Zhao¹⁵, Rui Wang^{16

17}, Ben Willem Mol¹⁷, Rong Li^{1

2

3

4

5

6}, He-Feng Huang¹⁸, Jie Qiao^{19

2

3

4

5

6}

Affiliations

¹ Centre for Reproductive Medicine, Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China.
² National Clinical Research Centre for Obstetrics and Gynecology, Beijing, China.
³ Key Laboratory of Assisted Reproduction (Peking University), Ministry of Education, Beijing, China.
⁴ Beijing Key Laboratory of Reproductive Endocrinology and Assisted Reproductive Technology, Beijing, China.
⁵ Beijing Advanced Innovation Centre for Genomics, Beijing, China.
⁶ Peking-Tsinghua Centre for Life Sciences, Peking University, Beijing, China.
⁷ Research Centre of Clinical Epidemiology, Peking University Third Hospital, Beijing, China.
⁸ Women's Hospital, Zhejiang University School of Medicine, Hangzhou, China.
⁹ Reproductive Medicine Centre of The Sixth Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.
¹⁰ First Affiliated Hospital of Kunming Medical University, Kunming, China.
¹¹ Haidian Maternal and Child Health Hospital, Beijing, China.
¹² First Affiliated Hospital of Anhui Medical University, Hefei, China.
¹³ The Second Hospital of Hebei Medical University, Shijiazhuang, China.
¹⁴ The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
¹⁵ General Hospital of Ningxia Medical University, Yinchuan, China.
¹⁶ Robinson Research Institute and Adelaide Medical School, Adelaide, South Australia, Australia.
¹⁷ Department of Obstetrics and Gynaecology, Monash University, Monash Medical Centre, Melbourne, Victoria, Australia.
¹⁸ The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China huanghefg@hotmail.com jie.qiao@263.net.
¹⁹ Centre for Reproductive Medicine, Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, China huanghefg@hotmail.com jie.qiao@263.net.

Abstract

Introduction: Intracytoplasmic sperm injection (ICSI), originally introduced as add-on to in vitro fertilisation (IVF) for couples with severe male infertility, is in current clinical practice also used in couples with mild male or even unexplained infertility. However, ICSI has involved unresolved concerns regarding the selection and damage to gametes and the health conditions of the offspring, and it is also labour intensive and therefore more expensive than conventional IVF. High-quality well-powered randomised clinical trials (RCTs) comparing ICSI and IVF are lacking.

Methods and analysis: We propose a multicentre, open-label RCT in 10 reproductive medical centres across China. We will study couples with non-severe male infertility (defined as a semen concentrate 5-15×10⁶/mL or sperm with a progressive motility 10%-32%) scheduled for their first or second ICSI or IVF cycle, as low fertility rate after fertilisation are more frequent in this population, which could lead to controversy about ICSI or conventional IVF for fertilisation. On the day of oocyte retrieval, eligible participants are after informed consent be randomised to undergo either ICSI or conventional IVF in a 1:1 treatment ratio. Other standard assisted reproductive treatments are similar and parallel between two groups. Our primary outcome is ongoing pregnancy leading to live birth after the first cycle with embryo transfer. To demonstrate or refute a difference of 7% between ICSI and conventional IVF, we need to include 2346 women (1173 in each intervention arm). In addition, we will follow-up neonatal outcomes after delivery to identify the influence of ICSI on offspring.

Ethics and dissemination: Ethical approval was obtained from Peking University Third Hospital medical science research ethics committee. The findings will be disseminated to the public through conference presentations and peer-reviewed scientific journals.

Trial registration number: ClinicalTrials.gov registry (NCT03298633).

Keywords: assisted reproductive technology; in vitro fertilisation; intracytoplasmic sperm injection; non-severe male infertility.

Publication types

Clinical Trial Protocol
Comparative Study
Research Support, Non-U.S. Gov't

MeSH terms

China
Female
Fertilization in Vitro* / methods
Humans
Infertility, Male*
Male
Multicenter Studies as Topic
Randomized Controlled Trials as Topic
Sperm Injections, Intracytoplasmic* / methods

Associated data

ClinicalTrials.gov/NCT03298633