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Ovarian Hyperstimulation Syndrome in Patients Triggered by GnRH Agonist for Excessive Follicular Response (COAGO)

Primary Purpose

Ovarian Hyperstimulation Syndrome, Hypercoagulability

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
COAGO
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ovarian Hyperstimulation Syndrome focused on measuring GnRH agonist triggering

Eligibility Criteria

18 Years - 43 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • estradiol level ≥ 3000 pg/mL and/or more than 20 follicles ≥ 11mm on the day of triggering and antagonist protocol

Exclusion Criteria:

  • agonist protocol no health assurance estradiol level < 3000 pg/mL and less than 20 follicles ≥ 11mm on the day of triggering

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    COAGO

    Arm Description

    All patients undergoing antagonist protocol and at high risk of OHSS (estradiol level ≥ 3000 pg/mL and/or more than 20 follicles ≥ 11mm on the day of triggering) were triggered by GnRH agonist.

    Outcomes

    Primary Outcome Measures

    Number of patients with the presence of moderate to severe OHSS
    The OHSS defined by the classification of the "practice committee of the American Society for Reproductive Medicine" following biological, clinical and ultrasonographical criteria (composite): Clinical: weight, waist circumference, dyspnea, EVA, diuresis Organic: NFS, electrolytes, creatinine, urea, AST / ALT, albumin, serum protein Ultrasound: ovarian size, quantification of ascites (Douglas, Morrison, parieto-colic gutters, vesico-uterine space).

    Secondary Outcome Measures

    Dosage of Prothrombin time
    Dosage of APTT
    Dosage of fibrinogen
    Dosage of von Willebrand factor antigen Antithrombin,
    Dosage of DDimères
    Dosage of oestradiol
    To evaluate its decrease.
    Dosage of progesterone
    To evaluate the quality of lutea and date of post punctures rules
    Cumulative pregnancy rate after transfer of thawed embryos.
    Number of patients with the presence of moderate to severe OHSS
    The OHSS defined by the classification of the "practice committee of the American Society for Reproductive Medicine" following biological, clinical and ultrasonographical criteria (composite): Clinical: weight, waist circumference, dyspnea, EVA, diuresis Organic: NFS, electrolytes, creatinine, urea, AST / ALT, albumin, serum protein Ultrasound: ovarian size, quantification of ascites (Douglas, Morrison, parieto-colic gutters, vesico-uterine space).

    Full Information

    First Posted
    February 25, 2016
    Last Updated
    October 1, 2019
    Sponsor
    University Hospital, Lille
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02701452
    Brief Title
    Ovarian Hyperstimulation Syndrome in Patients Triggered by GnRH Agonist for Excessive Follicular Response
    Acronym
    COAGO
    Official Title
    Prevalence of Ovarian Hyperstimulation Syndrome in Patients Triggered by GnRH Agonist for Excessive Follicular Response After Ovarian Stimulation With a GnRH Antagonist
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Terminated
    Study Start Date
    February 26, 2016 (Actual)
    Primary Completion Date
    January 1, 2019 (Actual)
    Study Completion Date
    January 1, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Lille

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    In the literature, the risk of moderate to severe OHSS is 3 to 6% and reaches 31% in high risk populations 9 days after oocyte triggering with hCG. Many studies report no or a markedly decreased risk of OHSS after triggering ovulation with a GnRH agonist. However, criteria to define OHSS are rarely explained and OHSS itself is not thoroughly asserted. It is well known that OHSS is associated with hypercoagulability. However, no study after triggering with a GnRH agonist assessed haemostasis in these high-risk patients with high circulating estradiol levels. Study design, size, duration: In a French academic reproductive medicine centre, a systematic prospective observational follow-up of all patients triggered by GnRH agonist for excessive follicular response will be conducted. Participants/materials, setting, methods: All patients undergoing antagonist protocol and at high risk of OHSS (estradiol level ≥ 3000 pg/mL and/or more than 20 follicles ≥ 11mm on the day of triggering) will be triggered by GnRH agonist. No luteal phase support and a "freeze-all" strategy will be performed. On the day of oocyte retrieval (T0), at 48h (T1) and at day 7 (T2), OHSS and hypercoagulability will be systematically assessed. Haemostasis data will be compared to the initial status of each patient.
    Detailed Description
    Seventy-five patients will be required for this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ovarian Hyperstimulation Syndrome, Hypercoagulability
    Keywords
    GnRH agonist triggering

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    1 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    COAGO
    Arm Type
    Experimental
    Arm Description
    All patients undergoing antagonist protocol and at high risk of OHSS (estradiol level ≥ 3000 pg/mL and/or more than 20 follicles ≥ 11mm on the day of triggering) were triggered by GnRH agonist.
    Intervention Type
    Other
    Intervention Name(s)
    COAGO
    Intervention Description
    blood samples for haemostasis and hormonal data
    Primary Outcome Measure Information:
    Title
    Number of patients with the presence of moderate to severe OHSS
    Description
    The OHSS defined by the classification of the "practice committee of the American Society for Reproductive Medicine" following biological, clinical and ultrasonographical criteria (composite): Clinical: weight, waist circumference, dyspnea, EVA, diuresis Organic: NFS, electrolytes, creatinine, urea, AST / ALT, albumin, serum protein Ultrasound: ovarian size, quantification of ascites (Douglas, Morrison, parieto-colic gutters, vesico-uterine space).
    Time Frame
    The day of oocyte retrieval (Time 0).
    Secondary Outcome Measure Information:
    Title
    Dosage of Prothrombin time
    Time Frame
    The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
    Title
    Dosage of APTT
    Time Frame
    The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
    Title
    Dosage of fibrinogen
    Time Frame
    The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
    Title
    Dosage of von Willebrand factor antigen Antithrombin,
    Time Frame
    The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
    Title
    Dosage of DDimères
    Time Frame
    The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
    Title
    Dosage of oestradiol
    Description
    To evaluate its decrease.
    Time Frame
    The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
    Title
    Dosage of progesterone
    Description
    To evaluate the quality of lutea and date of post punctures rules
    Time Frame
    The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3)
    Title
    Cumulative pregnancy rate after transfer of thawed embryos.
    Time Frame
    2 months after the transfer of the last thawed embryo
    Title
    Number of patients with the presence of moderate to severe OHSS
    Description
    The OHSS defined by the classification of the "practice committee of the American Society for Reproductive Medicine" following biological, clinical and ultrasonographical criteria (composite): Clinical: weight, waist circumference, dyspnea, EVA, diuresis Organic: NFS, electrolytes, creatinine, urea, AST / ALT, albumin, serum protein Ultrasound: ovarian size, quantification of ascites (Douglas, Morrison, parieto-colic gutters, vesico-uterine space).
    Time Frame
    2 days after (T1) and 7 days after (T2) the oocyte retrieval

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    43 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: estradiol level ≥ 3000 pg/mL and/or more than 20 follicles ≥ 11mm on the day of triggering and antagonist protocol Exclusion Criteria: agonist protocol no health assurance estradiol level < 3000 pg/mL and less than 20 follicles ≥ 11mm on the day of triggering
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sophie Catteau-Jonard, MD, PhD
    Organizational Affiliation
    University Hospital, Lille
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Ovarian Hyperstimulation Syndrome in Patients Triggered by GnRH Agonist for Excessive Follicular Response

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