ICSI Versus Conventional IVF in Couples With Unexplained Infertility

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.

Conditions

• Unexplained Infertility

Interventions

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

• Renmin Hospital of Wuhan University

  collaborator OTHER

• Jiaxing Maternity and Child Health Care Hospital

  collaborator OTHER

• Ningbo Women & Children's Hospital

  collaborator OTHER

• Beijing Obstetrics and Gynecology Hospital

  collaborator OTHER

• Xiangyang Central Hospital

  collaborator OTHER

• Huangshi Central Hospital

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  lead OTHER

Principal Investigators

• Min Jin, PhD · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

38 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-01

Primary Completion

2028-07-30

Completion

2028-07-30

Countries

• China

Study Locations