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

NCT03647020 | Completed

• 1 other identifier: PI2017_843_0044
• Study Type: observational
• Target: 633
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pesticide Poisoning

Keywords

oocyte; ovarian stimulation; dysmorphic cytoplasm

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Officials

• Moncef Ben Khlifa, MD

  CHU AMIENS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 27, 2018
• Study Start: January 1, 2011
• Primary Completion: June 6, 2017
• Study Completion: June 6, 2017
• Last Updated: May 17, 2023

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share