ICSI Versus Conventional IVF in Couples With Non-severe Male Infertility

  • End date
    Jul 13, 2022
  • participants needed
  • sponsor
    Jie Qiao
Updated on 13 May 2021
intracytoplasmic sperm injection
sperm concentration


A multicenter, parallel-controlled(1:1 treatment ratio), open-label, randomized clinical trials regarding fertilization and pregnancy outcomes between ICSI and conventional IVF among couples with no-severe male-factor infertility in China.


A multicenter, large-scale, randomized controlled clinical trial will enroll 2,346 couples with non-severe male infertility undergoing their first or second cycle of IVF or ICSI. The study will recruit participants from 6 Reproductive Medical Centers across mainland China.The participation in this study will be approximately 2 years with a total of 7 visits from controlled ovarian hyperstimulation, pregnancy to delivery. On the day of oocyte retrieval, eligible participants will be allocated to two groups at a ratio of 1:1- ICSI protocol, and conventional IVF protocol. All participants will be randomized through stratified block randomization according to the study sites.

Condition Male infertility
Treatment ICSI, Conventional IVF
Clinical Study IdentifierNCT03298633
SponsorJie Qiao
Last Modified on13 May 2021


Yes No Not Sure

Inclusion Criteria

Infertile couples scheduled for their first or second IVF/ICSI cycle
Men with non-severe male infertility: Sperm concentration 5,000,000-15,000,000/ml or sperm with progressive motility (type A+B) 10-32%
Women received either gonadotrophin-releasing hormone agonist protocol or gonadotrophin-releasing hormone antagonist protocol as their controlled ovarian hyperstimulation treatment
Informed consent obtained

Exclusion Criteria

Couple with contraindication for IVF or ICSI
Couples receiving donor sperm or donor eggs
Couples undergoing PGD and PGS
Sperm concentration with progressive motility used for insemination <100,000/ml on the day of oocyte retrieval
Women with 0 oocytes after oocyte retrieval
Using frozen semen
Poor fertilization in previous cycle ( 25%)
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