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Acrosome Reaction Induction Prior to ICSI

NCT02271490 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2026-05-20

No results posted yet for this study

Summary

Introduction To get through the egg vestment and fertilize the oocyte, the spermatozoon uses its acrosomal enzymes. When Intracytoplasmic sperm microinjection (ICSI) is performed, the acrosomal enzymes are introduced with the spermatozoa inside the ooplasme.

The fate of these enzymes, that normally never enter the oocyte, is not known. But they impair the embryo development.

Indeed, although the ICSI outcome is satisfactory in humans, a series of studies in many species (mouse, hamster, cattle, and horse) demonstrate the deleterious effects of the introduction of acrosomal material in the oocyte cytoplasm, on embryo and fetal development. These studies have also shown two things:

* The bigger the acrosome, the more deleterious are the effects of their introduction into the egg.
* And that the induction of the acrosome reaction (AR) prior to ICSI significantly improves embryonic development and the number of babies born after embryo transfer as it is the case in the mouse. The microinjection of acrosome reacted sperm increases from 40 to 70 % the percentage of pups born per embryo transferred.

Hypothesis :

It is possible to improve ICSI outcome, in terms of babies born in human, by induction of the AR prior to microinjection.

After studying several techniques, we choose a physiologic technique for acrosome induction.

The induction of acrosome reaction prior to ICSI should improve in utero fetal development and decrease the rate of miscarriage and pregnancy arrest.

Conditions

  • Assisted Reproductive Technique
  • ICSI
  • Acrosome Reaction
  • Pregnancy Outcome

Interventions

OTHER

Acrosome Reaction induction

OTHER

capacitation in incubation medium prior to ICSI

Sponsors & Collaborators

  • Agence de La Biomédecine

    collaborator OTHER_GOV

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
43 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-13
Primary Completion
2015-05-18
Completion
2015-12-18

Countries

  • France

Study Locations

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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 NCT02271490 on ClinicalTrials.gov