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

Study Overview
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Brief Summary
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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
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Seventy-five patients will be required for this study.

Official Title
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Prevalence of Ovarian Hyperstimulation Syndrome in Patients Triggered by GnRH Agonist for Excessive Follicular Response After Ovarian Stimulation With a GnRH Antagonist

Conditions
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Ovarian Hyperstimulation Syndrome, Hypercoagulability

Intervention / Treatment
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* Other: COAGO


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COAGO<br>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. | Other: COAGO<br>* blood samples for haemostasis and hormonal data<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | The day of oocyte retrieval (Time 0). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosage of Prothrombin time |  | The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3) | 
| Dosage of APTT |  | The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3) | 
| Dosage of fibrinogen |  | The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3) | 
| Dosage of von Willebrand factor antigen Antithrombin, |  | The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3) | 
| Dosage of DDimères |  | The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3) | 
| Dosage of oestradiol | To evaluate its decrease. | The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3) | 
| Dosage of progesterone | To evaluate the quality of lutea and date of post punctures rules | The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3) | 
| Cumulative pregnancy rate after transfer of thawed embryos. |  | 2 months after the transfer of the last thawed embryo | 
| 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). | 2 days after (T1) and 7 days after (T2) the oocyte retrieval | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GnRH agonist triggering