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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03647020
Other study ID # PI2017_843_0044
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2011
Est. completion date June 6, 2017

Study information

Verified date August 2018
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 633
Est. completion date June 6, 2017
Est. primary completion date June 6, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Outcome

Type Measure Description Time frame Safety issue
Primary ICS outcomes of couples presenting differetn CLCG prevalence 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. 2years
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