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Abstract
Study questions
Does ICSI result in a higher live birth rate as compared with conventional IVF in couples with non-male factor infertility?
What is known already
ICSI is primarily indicated for severe male factor infertility. While the use of ICSI for couples with non-male factor infertility has been increasing worldwide, this is not supported by data from randomised controlled trials. Evidence from non-randomised studies suggest no benefit from ICSI compared with conventional IVF in non-male factor infertility, if not a harm.
Study design, size, duration
This randomised, open-label, multi-centre trial aims to compare the effectiveness of one ICSI cycle and one conventional IVF cycle in infertile couples with non-male factor infertility. A total of 1064 couples will be randomly allocated to an ICSI group and a conventional IVF group. The estimated duration of the study is 30 months.
Participants/materials, setting, methods
Eligible couples are those whose husbands’ total sperm count and motility are normal, have undergone ≤2 previous IVF/ICSI attempts, use antagonist protocol for ovarian stimulation, agree to have ≤2 embryos transferred and are not participating in another IVF study at the same time. Women undergoing IVM cycles, using frozen semen or having a poor fertilisation (≤25%) in previous cycle will not be eligible. Couples will be randomised to undergo ICSI or conventional IVF (1:1) with ongoing pregnancy resulting in live birth after the first embryo transfer of the started treatment cycle as the primary endpoint. All analyses will be conducted on an intention-to-treat basis. Effect sizes will be summarised as relative risk (RR), with precision evaluated by 95% CIs.
STUDY FUNDING/COMPETING INTEREST(S)
All authors declare having no conflict of interests with regards to this trial. This work was supported by a grant from MSD [MISP #57508].
Trial registration number
NCT03428919.
Trial registration date
8 February 2018.
DATE OF FIRST PATIENT’S ENROLMENT
16 March 2018.
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Details
1 IVFMD, My Duc Hospital, 4 Nui Thanh, Tan Binh District, Ho Chi Minh City, Vietnam; HOPE Research Center, My Duc Hospital, 4 Nui Thanh, Tan Binh District, Ho Chi Minh City, Vietnam
2 HOPE Research Center, My Duc Hospital, 4 Nui Thanh, Tan Binh District, Ho Chi Minh City, Vietnam; Department of Obstetrics and Gynaecology, University of Medicine and Pharmacy at Ho Chi Minh City, 217 Hong Bang, District 5, Ho Chi Minh City, Vietnam
3 HOPE Research Center, My Duc Hospital, 4 Nui Thanh, Tan Binh District, Ho Chi Minh City, Vietnam; IVFAS, An Sinh Hospital, 10 Tran Huy Lieu, Phu Nhuan District, Ho Chi Minh City, Vietnam
4 IVFMD, My Duc Hospital, 4 Nui Thanh, Tan Binh District, Ho Chi Minh City, Vietnam
5 IVFAS, An Sinh Hospital, 10 Tran Huy Lieu, Phu Nhuan District, Ho Chi Minh City, Vietnam
6 Discipline of Obstetrics and Gynaecology, Robinson Research Institute and Adelaide Medical School, The University of Adelaide, Ground Floor, 55 King William Road, North Adelaide SA 5006 Adelaide, Australia
7 Discipline of Obstetrics and Gynaecology, Robinson Research Institute and Adelaide Medical School, The University of Adelaide, Ground Floor, 55 King William Road, North Adelaide SA 5006 Adelaide, Australia; Fertility SA, 431 King William Street, South Australia 5000, Adelaide, Australia
8 Department of Obstetrics and Gynaecology, School of Medicine, Monash University, 246 Clayton Road, Clayton 3168, Victoria, Australia