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

Intracytoplasmic Sperm Injection (ICSI) Versus Conventional in Vitro Fertilization (IVF) in Couples With Non-severe Male Infertility: a Randomized Controlled Trial

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.

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%).