The effectiveness of ICSI versus conventional IVF in couples with non-male factor infertility: study protocol for a randomised controlled trial.
In: Human reproduction open, Jg. 2019 (2019-03-27), Heft 2, S. hoz006
Online
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Zugriff:
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 Interests: 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.
| Titel: |
The effectiveness of ICSI versus conventional IVF in couples with non-male factor infertility: study protocol for a randomised controlled trial.
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| Autor/in / Beteiligte Person: | Dang, VQ ; Vuong, LN ; Ho, TM ; Ha, AN ; Nguyen, QN ; Truong, BT ; Pham, QT ; Wang, R ; Norman, RJ ; Mol, BW |
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| Zeitschrift: | Human reproduction open, Jg. 2019 (2019-03-27), Heft 2, S. hoz006 |
| Veröffentlichung: | [Oxford] : Oxford University Press, [2017]-, 2019 |
| Medientyp: | academicJournal |
| ISSN: | 2399-3529 (electronic) |
| DOI: | 10.1093/hropen/hoz006 |
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