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ICSI Versus Conventional IVF in Couples With Unexplained Infertility
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Summary
This multicenter, open-label, parallel-group, randomized controlled trial aims to compare the live birth rate, fertilization outcomes, other pregnancy outcomes and safety between ICSI and conventional IVF among couples with unexplained infertility in China.
Official title: Intracytoplasmic Sperm Injection (ICSI) Versus Conventional in Vitro Fertilization (IVF) in Couples With Unexplained Infertility: a Multicenter, Open-label, Parallel-group, Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
20 Years - 38 Years
Study Type
INTERVENTIONAL
Enrollment
848
Start Date
2026-01-01
Completion Date
2028-07-30
Last Updated
2025-12-19
Healthy Volunteers
No
Conditions
Interventions
ICSI
Insemination will be performed by using ICSI, 2 hours after oocyte retrieval. COCs will be stripped by using hyaluronidase. Only matured oocytes (MII stage) will be injected. Fertilization check will be performed at period of 16-18 hours after injection. Other standard assisted reproductive treatments are similar and parallel between two groups.
IVF
Insemination will be performed by using conventional IVF, 2-4 hours after oocyte retrieval. Collected COCs will be inseminated (1-5×105 sperm/ml) and cultured overnight in culture medium. Fertilization check will be performed at period of 16-18 hours after insemination. If the IVF group experiences total fertilization failure or a fertilization rate of less than 25%, late rescue ICSI (Late-RICSI) will be performed on all MII stage oocytes using semen retained on the day of egg retrieval. The injection method is same as standard ICSI. Other standard assisted reproductive treatments are similar and parallel between two groups.
Locations (7)
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Huangshi Central Hospital
Huangshi, Hubei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Xiangyang Central Hospital
Xiangyang, Hubei, China
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Jiaxing Maternity and Child Health Care Hospital
Jiaxing, Zhejiang, China
Ningbo Women & Children's Hospital
Ningbo, Zhejiang, China