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A Study Comparing a Shorter Exposure of Oocyte to Spermatozoa Versus a Standard Incubation on the Live Birth Rate of In-vitro Fertilization Treatment

NCT02534857 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2015-08-28

No results posted yet for this study

Summary

In vitro fertilization (IVF) treatment is now commonly used to treat infertile couples. During IVF treatment, oocytes and sperm are routinely incubated overnight and this may lead to suboptimal culture conditions because of increased reactive oxygen species (ROS) produced by sperm in the standard incubation. High levels of ROS can adversely affect the quality of the embryos, result in hardening of the zona pellucida and impair the implantation capacity of embryos. Studies shows successful fertilization of an oocyte occurs 20mins after the gametes are put together. Sperm can penetrate through the cumulus cells within 15min, and 80% of oocytes can be fertilized when they are exposed to a large number of spermatozoa within 1hr. As an attempt to avoid possible detrimental effects on the oocytes from long exposure to sperm, the brief incubation insemination protocol was developed. It implies that prolonged incubation of oocytes and sperm may not be necessary and may even be harmful. Some reports suggest that a sperm-oocyte exposure time of 1-6 h improves IVF outcomes. However, other studies report no such advantage with a short insemination time .

A recent meta-analysis shows brief incubation of gametes was associated with significantly higher rates of clinical pregnancy , ongoing pregnancy and higher rate of implantation than standard incubation. But the rates of normal fertilization, good quality embryos and polyspermy were not significantly different compared with standard incubation. In a Cochrane meta-analysis, eight RCTs with 733 women were included, and showed similar results. But it only reported clinical pregnancy rate and ongoing pregnancy rate which were significantly higher in brief incubation group than standard incubation. However, the live birth rate, which is the important outcome parameter, was not reported in all these studies. It is uncertain whether brief incubation improves the life birth rate compared with standard incubation.

The aim of this randomized double blinded study is to compare the live birth rate of IVF treatment following brief incubation of oocytes and sperm versus standard incubation. The hypothesis is that a brief incubation improves the live birth rate of IVF treatment.

Conditions

Interventions

PROCEDURE

a shorter exposure of oocyte to spermatozoa

Shorter exposure of oocyte to spermatozoa group: oocytes will be exposed to spermatozoa for 2 hours

Sponsors & Collaborators

  • The University of Hong Kong

    collaborator OTHER

  • Shanghai First Maternity and Infant Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-09-30
Completion
2017-09-30

Countries

  • China

Study Locations

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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 NCT02534857 on ClinicalTrials.gov