Status:
COMPLETED
ICSI Versus Conventional IVF in Couples With Non-severe Male Infertility
Lead Sponsor:
Jie Qiao
Collaborating Sponsors:
International Peace Maternity and Child Health Hospital
Women's Hospital School Of Medicine Zhejiang University
Conditions:
Male Infertility
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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-s...
Detailed 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 recrui...
Eligibility Criteria
Inclusion
- 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
- 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%).
Key Trial Info
Start Date :
April 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
2387 Patients enrolled
Trial Details
Trial ID
NCT03298633
Start Date
April 4 2018
End Date
March 31 2023
Last Update
July 27 2023
Active Locations (10)
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1
First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
2
Peking University third Hospital
Beijing, Beijing Municipality, China, 100191
3
Haidian Maternal and Child Health Hospital
Beijing, Beijing Municipality, China
4
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510150