In vitro fertilisation (IVF) versus intracytoplasmic sperm injection (ICSI) in patients without severe male factor infertility: Study protocol for the randomised, controlled, multicentre trial INVICSI
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In vitro fertilisation (IVF) versus intracytoplasmic sperm injection (ICSI) in patients without severe male factor infertility : Study protocol for the randomised, controlled, multicentre trial INVICSI. / Berntsen, Sine; Nøhr, Bugge; Grøndahl, Marie Louise; Petersen, Morten Rønn; Andersen, Lars Franch; Englund, Anne Lis; Knudsen, Ulla Breth; Prætorius, Lisbeth; Zedeler, Anne; Nielsen, Henriette Svarre; Pinborg, Anja; Freiesleben, Nina La Cour.
In: BMJ Open, Vol. 11, No. 6, e051058, 2021.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - In vitro fertilisation (IVF) versus intracytoplasmic sperm injection (ICSI) in patients without severe male factor infertility
T2 - Study protocol for the randomised, controlled, multicentre trial INVICSI
AU - Berntsen, Sine
AU - Nøhr, Bugge
AU - Grøndahl, Marie Louise
AU - Petersen, Morten Rønn
AU - Andersen, Lars Franch
AU - Englund, Anne Lis
AU - Knudsen, Ulla Breth
AU - Prætorius, Lisbeth
AU - Zedeler, Anne
AU - Nielsen, Henriette Svarre
AU - Pinborg, Anja
AU - Freiesleben, Nina La Cour
N1 - Publisher Copyright: © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2021
Y1 - 2021
N2 - Introduction Over the last decades, the use of intracytoplasmic sperm injection (ICSI) has increased, even among patients without male factor infertility. The increase has happened even though there is no evidence to support that ICSI results in higher live birth rates compared with conventional in vitro fertilisation (IVF) in cases with nonmale factor infertility. The lack of robust evidence on an advantage of using ICSI over conventional IVF in these patients is problematic since ICSI is more invasive, complex and requires additional resources, time and effort. Therefore, the primary objective of the IVF versus ICSI (INVICSI) study is to determine whether ICSI is superior to standard IVF in patients without severe male factor infertility. The primary outcome measure is first live birth from fresh and frozen-thawed transfers after one stimulated cycle. Secondary outcomes include fertilisation rate, ongoing pregnancy rate, birth weight and congenital anomalies. Methods and analysis This is a two-armed, multicentre, randomised, controlled trial. In total, 824 couples/women with infertility without severe male factor will be recruited and allocated randomly into two groups (IVF or ICSI) in a 1:1 ratio. Participants will be randomised in variable block sizes and stratified by trial site and age. The main inclusion criteria are (1) no prior IVF/ICSI treatment, (2) male partner sperm with an expected count of minimum 2 million progressive motile spermatozoa following density gradient purification on the day of oocyte pick up and (3) age of the woman between 18 and 42 years. Ethics and dissemination The study will be performed in accordance with the ethical principles in the Helsinki Declaration. The study is approved by the Scientific Ethical Committee of the Capital Region of Denmark. Study findings will be presented, irrespectively of results at international conferences and submitted for publication in peer-reviewed journals. Pre-results.
AB - Introduction Over the last decades, the use of intracytoplasmic sperm injection (ICSI) has increased, even among patients without male factor infertility. The increase has happened even though there is no evidence to support that ICSI results in higher live birth rates compared with conventional in vitro fertilisation (IVF) in cases with nonmale factor infertility. The lack of robust evidence on an advantage of using ICSI over conventional IVF in these patients is problematic since ICSI is more invasive, complex and requires additional resources, time and effort. Therefore, the primary objective of the IVF versus ICSI (INVICSI) study is to determine whether ICSI is superior to standard IVF in patients without severe male factor infertility. The primary outcome measure is first live birth from fresh and frozen-thawed transfers after one stimulated cycle. Secondary outcomes include fertilisation rate, ongoing pregnancy rate, birth weight and congenital anomalies. Methods and analysis This is a two-armed, multicentre, randomised, controlled trial. In total, 824 couples/women with infertility without severe male factor will be recruited and allocated randomly into two groups (IVF or ICSI) in a 1:1 ratio. Participants will be randomised in variable block sizes and stratified by trial site and age. The main inclusion criteria are (1) no prior IVF/ICSI treatment, (2) male partner sperm with an expected count of minimum 2 million progressive motile spermatozoa following density gradient purification on the day of oocyte pick up and (3) age of the woman between 18 and 42 years. Ethics and dissemination The study will be performed in accordance with the ethical principles in the Helsinki Declaration. The study is approved by the Scientific Ethical Committee of the Capital Region of Denmark. Study findings will be presented, irrespectively of results at international conferences and submitted for publication in peer-reviewed journals. Pre-results.
KW - male infertility
KW - reproductive medicine
KW - sexual medicine
KW - subfertility
U2 - 10.1136/bmjopen-2021-051058
DO - 10.1136/bmjopen-2021-051058
M3 - Journal article
C2 - 34168037
AN - SCOPUS:85108687887
VL - 11
JO - BMJ Open
JF - BMJ Open
SN - 2044-6055
IS - 6
M1 - e051058
ER -
ID: 273644768