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
About this trial
This is an interventional diagnostic trial for Ovarian Hyperstimulation Syndrome focused on measuring GnRH agonist triggering
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
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
NCT ID
NCT02701452
First Posted
February 25, 2016
Last Updated
October 1, 2019
Sponsor
University Hospital, Lille
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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