NCT02271490

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
620

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 22, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 16, 2015

Status Verified

October 1, 2015

Enrollment Period

1.6 years

First QC Date

October 7, 2014

Last Update Submit

October 15, 2015

Conditions

Assisted Reproductive TechniqueICSIAcrosome ReactionPregnancy Outcome

Keywords

Assisted Reproductive TechniqueICSIAcrosome ReactionPregnancy outcome

Outcome Measures

Primary Outcomes (1)

  • number of early pregnancy termination

    9 months

Study Arms (2)

micoinjection according to classical protocole

ACTIVE COMPARATOR

incubation of sperm in incubation medium

Other: capacitation in incubation medium prior to ICSI

incubation in follicular fluid

EXPERIMENTAL

incubation of sperm in follicular fluid prior to microinjection

Other: Acrosome Reaction induction

Interventions

Acrosome Reaction inductionOTHER
incubation in follicular fluid
capacitation in incubation medium prior to ICSIOTHER
micoinjection according to classical protocole

Eligibility Criteria

Age18 Years - 43 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Couples involved in an ICSI program
  • First attempt only
  • Cohort with at least 6 oocytes

You may not qualify if:

  • No social security number
  • No signed consent form
  • Surgically retrieved sperm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Cochin

Paris, 75014, France

Location

Related Publications (3)

  • Lacham-Kaplan O, Trounson A. Intracytoplasmic sperm injection in mice: increased fertilization and development to term after induction of the acrosome reaction. Hum Reprod. 1995 Oct;10(10):2642-9. doi: 10.1093/oxfordjournals.humrep.a135760.

    PMID: 8567785BACKGROUND

  • Roldan ER. Better intracytoplasmic sperm injection without sperm membranes and acrosome. Proc Natl Acad Sci U S A. 2006 Nov 21;103(47):17585-6. doi: 10.1073/pnas.0608752103. Epub 2006 Nov 13. No abstract available.

    PMID: 17101960BACKGROUND

  • Morozumi K, Shikano T, Miyazaki S, Yanagimachi R. Simultaneous removal of sperm plasma membrane and acrosome before intracytoplasmic sperm injection improves oocyte activation/embryonic development. Proc Natl Acad Sci U S A. 2006 Nov 21;103(47):17661-6. doi: 10.1073/pnas.0608183103. Epub 2006 Nov 7.

    PMID: 17090673BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2014

First Posted

October 22, 2014

Study Start

June 1, 2014

Primary Completion

January 1, 2016

Study Completion

October 1, 2016

Last Updated

October 16, 2015

Record last verified: 2015-10

Locations

FR(1)