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ICSI Versus Conventional IVF in Non-male Factor Couples

NCT03428919 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1064

Last updated 2020-10-09

No results posted yet for this study

Summary

Conventionally, ICSI was initially developed and has been shown to be an effective treatment for male factor infertility. It is increasingly being used for patients without a male factor diagnosis, despite the lack of clinical evidence to support its use. Moreover, ICSI is an invasive and expensive procedure. This multi-center, randomized, controlled, parallel-group trial will be conducted to compare the effectiveness of ICSI versus conventional IVF in infertile couples scheduled for IVF treatment, in whom the male partner has normal sperm.

Conditions

Interventions

PROCEDURE

ICSI

In ICSI group, insemination will be performed by using ICSI, 3 - 4 hours after oocyte retrieval. OCCs will be stripped by using hyaluronidase. Only matured oocytes will be inseminated.

PROCEDURE

IVF

In IVF group, insemination will be performed by conventional IVF. Two hours after retrieval, collected OCCs will be inseminated for another 2 hours, at a concentration of 100,000 motile sperm/ml. Inseminated OCCs will be cultured overnight in culture medium.

Sponsors & Collaborators

  • An Sinh Hospital

    collaborator OTHER

  • Mỹ Đức Hospital

    lead OTHER

Principal Investigators

  • Lan N Vuong, PhD · University of Medicine and Pharmacy at Ho Chi Minh City

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-16
Primary Completion
2020-08-01
Completion
2020-08-12

Countries

  • Vietnam

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03428919 on ClinicalTrials.gov