Pesticide PoisoningCLCG-ICSINCT03647020
Impact of Oocytes With CLCG on ICSI Outcomes and Their Potential Relation to Pesticide Exposure
An observational study of Pesticide Poisoning, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pesticide Poisoning
- How many people
- 633 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2011to 6 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- female < 18 years > 35 yeas old
- couple with severe male infertility factors on oocyte activation and subsequent embryo development
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pesticide Poisoning
- Keywords
- oocyte, ovarian stimulation, dysmorphic cytoplasm
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start1 Jan 2011
- Primary completion6 Jun 2017
- Study completion6 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pesticide PoisoningStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 633 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moncef Ben Khalifa, PU-PH, Principal investigator, CHU Amiens-Picardie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03647020
- Sponsor's protocol ID
- PI2017_843_0044
- Acronym
- CLCG-ICSI
- Status last verified
- Jun 2026
- First submitted
- 23 Aug 2018
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Oocytes With CLCG on ICSI Outcomes and Their Potential Relation to Pesticide Exposure
- ClinicalTrials.gov ID
- NCT03647020
- Acronym / sponsor ID
- CLCG-ICSI / PI2017_843_0044
- Conditions
- Pesticide Poisoning
- Keywords
- oocyte, ovarian stimulation, dysmorphic cytoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 633 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 6 Jun 2017 (actual)
- Study completion
- 6 Jun 2017 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- female < 18 years > 35 yeas old
- couple with severe male infertility factors on oocyte activation and subsequent embryo development
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moncef Ben Khalifa, PU-PH principal investigator
CHU Amiens-Picardie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pesticide Poisoning, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICS outcomes of couples presenting differetn CLCG prevalence (time frame: 2years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.