Hypercoagulability, Ovarian Hyperstimulation Syndrome
Conditions
Keywords
GnRH agonist triggering
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.
Interventions
OTHERCOAGO
blood samples for haemostasis and hormonal data
Sponsors
University Hospital, Lille
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with the presence of moderate to severe OHSS | The day of oocyte retrieval (Time 0). | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 Prothrombin time | The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3) | — |
| Dosage of progesterone | The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3) | To evaluate the quality of lutea and date of post punctures rules |
| 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 | 2 days after (T1) and 7 days after (T2) the oocyte retrieval | 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). |
| Dosage of oestradiol | The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3) | To evaluate its decrease. |
Outcome results
None listed