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Impact of Oocytes With CLCG on ICSI Outcomes and Their Potential Relation to Pesticide Exposure (CLCG-ICSI)

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ClinicalTrials.gov Identifier: NCT03647020
Recruitment Status : Completed
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:

Oocyte quality is a key limiting factor in female fertility which is primarily reflected in morphological features. Centrally located cytoplasm granulation (CLCG) is one type of cytoplasmic dimorphism exhibited by oocytes that could be linked to pesticide exposure with a significant risk of decreased ICSI outcomes.

This retrospective study included 633 women who were part of an intracytoplasmic spermatozoa injection (ICSI) program between 2009 and 2011. The participants lived in the Picardy region of France and had been exposed to pesticides. The participants were divided in two groups based on prevalence of oocytes with CLCG (LCLCG [n= 83]: low prevalence of oocytes with CLCG under 25%. HCLCG [ n= 68]: high prevalence of CLCG over 75%). The embryological and clinical outcomes were analysed for both groups and were calculated using the difference between the two values.


Condition or disease
Pesticide Poisoning

Detailed Description:

Oocyte quality is a key limiting factor in female fertility which is primarily reflected in morphological features. Centrally located cytoplasm granulation (CLCG) is one type of cytoplasmic dimorphism exhibited by oocytes that could be linked to pesticide exposure with a significant risk of decreased ICSI outcomes.

This retrospective study included 633 women who were part of an intracytoplasmic spermatozoa injection (ICSI) program between 2009 and 2011. The participants lived in the Picardy region of France and had been exposed to pesticides. The participants were divided in two groups based on prevalence of oocytes with CLCG (LCLCG [n= 83]: low prevalence of oocytes with CLCG under 25%. HCLCG [ n= 68]: high prevalence of CLCG over 75%). The embryological and clinical outcomes were analysed for both groups and were calculated using the difference between the two values. The included population in the investigator's retrospective study consisted of 633 couples who attended a reproductive medical center and who were part of an ICSI program between 2009 and 2011.


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Study Type : Observational
Actual Enrollment : 633 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Impact of Oocytes With CLCG on ICSI Outcomes and Their Potential Relation to Pesticide Exposure
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : June 6, 2017
Actual Study Completion Date : June 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pesticides Poisoning




Primary Outcome Measures :
  1. ICS outcomes of couples presenting differetn CLCG prevalence [ Time Frame: 2years ]
    The aim of the present study was to investigate the ICSI outcomes of couples presenting different CLCG prevalence's of retrieved oocytes (low prevalence of CLCG; fewer than 25% [LCLCG] and high prevalence of CLCG; over 75% [HCLCG]) and its correlation to pesticide exposure zones in the region of Picardy, France.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The population in the retrospective study consisted of 633 couples who attended a reproductive medical center and who were part of an ICSI program between 2009 and 2011. The study population is described in Table

1. In the selected couples, women were normo-responders (oocyte cohort over 5), under 35 years old, living in the Picardy, France region, and exhibited CLCG after oocyte morphology evaluation which was confirmed by a second embryologist (Fig. 1

Criteria

Inclusion Criteria:

  • couples who attendes a reproductive medical center
  • couples that were part of a ICSI program between 2009 and 2011
  • women were normo-responders
  • female > 18 years <35 yeas old

Exclusion Criteria:

  • female < 18 years > 35 yeas old
  • couple with severe male infertility factors on oocyte activation and subsequent embryo development

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647020


Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Moncef Ben Khlifa, MD CHU AMIENS

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03647020     History of Changes
Other Study ID Numbers: PI2017_843_0044
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire, Amiens:
oocyte
ovarian stimulation
dysmorphic cytoplasm

Additional relevant MeSH terms:
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Poisoning
Chemically-Induced Disorders