ICSI Versus Conventional IVF in Couples With Non-severe Male Infertility (ICSI/IVF-NSMI)

Jie Qiao

Status: Completed

Conditions: Male Infertility

Treatments: Other: ICSI; Other: Conventional IVF

Study type: Interventional

Funder types: Other

Identifiers

NCT03298633

ICSI/IVF-NSMI

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,387 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,387 participants in 2 patient groups

Intracytoplasmic Sperm Injection

Active Comparator group

Description:

On the day of oocyte retrieval, qualified participants will be randomized into either of two groups. Participants in group A will undergone Intracytoplasmic Sperm Injection (ICSI) procedure, other standard assisted reproductive treatments are similar and parallel between two groups.

Treatment:

Other: ICSI

Conventional IVF

Active Comparator group

Description:

On the day of oocyte retrieval, qualified participants will be randomized into either of two groups. Participants in this group will undergone Conventional In Vitro Fertilization (IVF) procedure, other standard assisted reproductive treatments are similar and parallel between two groups.

Treatment:

Other: Conventional IVF