In Vitro Fertilisation Versus Intracytoplasmic Sperm Injection in Patients Without Severe Male Factor Infertility

Author(s):  
BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e051058
Author(s):  
Sine Berntsen ◽  
Bugge Nøhr ◽  
Marie Louise Grøndahl ◽  
Morten Rønn Petersen ◽  
Lars Franch Andersen ◽  
...  

IntroductionOver 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 analysisThis 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 disseminationThe 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.Trial registration numberNCT04128904. Pre-results.


2017 ◽  
Vol 63 (8) ◽  
pp. 697-703 ◽  
Author(s):  
Edson Borges Jr. ◽  
Bianca Ferrarini Zanetti ◽  
Daniela Paes de Almeida Ferreira Braga ◽  
Amanda Souza Setti ◽  
Rita de Cássia Sávio Figueira ◽  
...  

Summary Objective: To evaluate the effect of male factor infertility on intracytoplasmic sperm injection (ICSI) outcomes compared with a control group presenting isolated tubal factor. Method: This retrospective study included 743 couples undergoing ICSI as a result of isolated male factor and a control group consisting of 179 couples undergoing ICSI as a result of isolated tubal factor, performed in a private university- -affiliated in vitro fertilization center, between January/2010 and December/2016. Patients were divided into two groups according to maternal age: women ≤35 years old and >35 years old. The effects of infertility causes on laboratorial and clinical ICSI outcomes were evaluated using Student's t-test and (2 test. Results: No differences in controlled ovarian stimulation outcomes were observed between male factor cycles and tubal factor cycles in the two age groups. Implantation (male factor 35.5% vs. tubal factor 32.0%, p=0.340), pregnancy (male factor 46.9% vs. tubal factor 40.9%, p=0.184) and miscarriage (male factor 10.3% vs. tubal factor 10.6%, p=0.572) rates were similar between the infertility groups, irrespective of female age. Considering maternal age, the cancelation rate was higher in older women (>35 years old) undergoing ICSI as a result of male factor infertility (17.4% vs. 8.9%, p=0.013). Conclusion: Our results showed that there is no difference in the outcomes of pregnancy between couples with male or tubal factor infertility, which indicates that ICSI surpasses the worse specific outcomes associated with male factor.


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