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

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-severe male-factor infertility in China.

Conditions

• Male Infertility

Interventions

OTHER

ICSI

All patients will receive controlled ovarian hyperstimulation (COH) treatment, which is performed by standard routines at each study center. The COH treatment includes either gonadotrophin-releasing hormone agonist (GnRH-a) protocol or gonadotrophin-releasing hormone antagonist (GnRH-ant) protocol.Oocyte retrieval is scheduled for 36 (±2) after hCG injection.The retrieved cumulus oocyte complexes (COC) will be allocated to undergo routine ICSI procedure according to the result of randomization in each study site.

OTHER

Conventional IVF

All patients will receive controlled ovarian hyperstimulation (COH) treatment, which is performed by standard routines at each study center. The COH treatment includes either gonadotrophin-releasing hormone agonist (GnRH-a) protocol or gonadotrophin-releasing hormone antagonist (GnRH-ant) protocol.Oocyte retrieval is scheduled for 36 (±2) after hCG injection.The retrieved cumulus oocyte complexes (COC) will be allocated to undergo conventional IVF procedure according to the result of randomization in each study site.

Sponsors & Collaborators

• International Peace Maternity and Child Health Hospital

  collaborator OTHER

• Women's Hospital School Of Medicine Zhejiang University

  collaborator OTHER

• Sixth Affiliated Hospital, Sun Yat-sen University

  collaborator OTHER

• First Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• Beijing Haidian Maternal and Child Health Hospital

  collaborator OTHER

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• The Second Hospital of Hebei Medical University

  collaborator OTHER

• The Third Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• General Hospital of Ningxia Medical University

  collaborator OTHER

• Jie Qiao

  lead OTHER

Principal Investigators

• Jie Qiao, M.D. · Peking University Third Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-04

Primary Completion

2023-01-31

Completion

2023-03-31

Countries

• China

Study Locations