Prevalence of Ovarian Hyperstimulation Syndrome in Patients Triggered by GnRH Agonist for Excessive Follicular Response After Ovarian Stimulation With a GnRH Antagonist
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 主要终点
- Number of patients with the presence of moderate to severe OHSS
研究概览
简要总结
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.
详细描述
Seventy-five patients will be required for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •estradiol level ≥ 3000 pg/mL and/or more than 20 follicles ≥ 11mm on the day of triggering and antagonist protocol
排除标准
- •agonist protocol no health assurance estradiol level < 3000 pg/mL and less than 20 follicles ≥ 11mm on the day of triggering
研究组 & 干预措施
COAGO
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.
干预措施: COAGO (Other)
结局指标
主要结局
Number of patients with the presence of moderate to severe OHSS
时间窗: 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).
次要结局
- 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 Prothrombin time(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 progesterone(The day of oocyte retrieval (Time 0), 2 days after (T1), 7 days after (T2), 6 weeks after (T3))
- Dosage of oestradiol(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(2 days after (T1) and 7 days after (T2) the oocyte retrieval)