Clinical trial NCT03647020: Impact of Oocytes With CLCG on ICSI Outcomes and Their Potential Relation to Pesticide Exposure
Official title: Impact of Oocytes With CLCG on ICSI Outcomes and Their Potential Relation to Pesticide Exposure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pesticide Poisoning
Keywords: oocyte
ovarian stimulation
dysmorphic cytoplasm
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 633
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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

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.

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.

Eligibility 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

Primary outcomes:
measure: ICS outcomes of couples presenting differetn CLCG prevalence
timeFrame: 2years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU AMIENS
name: Moncef Ben Khlifa, MD
role: PRINCIPAL_INVESTIGATOR
References: