NCT02941965.

Study name	Preimplantation Genetic Screening in Patients With Male Factor Infertility
Methods	Randomised controlled trial
Participants	Sample size: 480 Inclusion criteria: Male patients between 20 to 50 years old Male patients diagnosed with oligospermia or asthenospermia according to the ESHRE criteria Male patients who intended to undergo ICSI and had signed a written consent form Exclusion criteria: Male patients with azoospermia, sexual dysfunction, immunological infertility Spouse with advanced age (> 35 years old) Spouse who has previously been diagnosed with a uterine abnormality such as a malformed uterus (uterus unicornis, septate uterus, duplex uterus or uterus bicomis), adenomyosis, submucous myoma or intrauterine adhesion Spouse with ovulation dysfunction‐related disease such as endometriosis, polycystic ovarian syndrome (tubal factors are not included); undiagnosed infertility Spouse who has experienced recurrent spontaneous abortions (including biochemical pregnancy abortion), defined as 3 or more previous pregnancy losses Patients or their partners with an abnormal chromosome karyotype not including chromosome polymorphisms, which mainly refer to the variants in the chromosomal heterochromatin region Spouse with medical conditions that contraindicate assisted reproductive technology or pregnancy, or both, such as poorly controlled type 1 or type 2 diabetes mellitus; undiagnosed liver disease or dysfunction (based on serum liver enzyme test results); renal disease or abnormal serum renal function; significant anaemia; history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident; uncontrolled hypertension or known symptomatic heart disease; history of (or suspected) cervical carcinoma, endometrial carcinoma, or breast carcinoma; and undiagnosed vaginal bleeding Male patients with medical conditions that contraindicate assisted reproductive technology or pregnancy, or both, such as poorly controlled type 1 or type 2 diabetes mellitus; undiagnosed liver disease or dysfunction (based on serum liver enzyme test results); renal disease or abnormal serum renal function; significant anaemia; history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident; uncontrolled hypertension or known symptomatic heart disease Male patients or their partners who are unable to comply with the study procedures Male patients who had previously been randomised to either of the 2 study groups in this trial
Interventions	ICSI with PGS, PGS will be applied to select embryos on day 5, only euploid embryos will be transferred. A maximum of 2 embryos will be transferred for each treatment cycle.
Outcomes	Primary outcome: live birth rate
Starting date	May 2017
Contact information	He‐Feng Huang, MD International Peace Maternity & Child Health Hospital, Shanghai Telephone +86‐21‐18017310186 Email: hefenghuang@126.com
Notes	First posted 21 October 2016, last updated 15 March 2017