Method for Determining Optimal FSH Dosage During in Vitro Fertilization (IVF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Consistency of optimal ovarian response during stimulation.
研究概览
简要总结
During in vitro fertilisation (IVF) treatment, women receive hormone stimulation with gonadotropins to induce growth of several ovarian follicles. Selecting the optimal dosage of gonadotropin is important to avoid maturation of too few or too many follicles, which may impair the chances of treatment success, lead to treatment cancellation, or serious side effects.
Motivated by the lack of standardised procedures to estimate the optimal dosage of gonadotropins, a patient-specific test has been developed to predict the optimal hormone dosage. By measuring internalisation of gonadotropin by the patient's monocytes isolated form the peripheral blood ex vivo, the Gonadotropin Removal Test determines whether a patient needs increased or reduced hormon doses.
In this clinical study the investigators compare deviation from optimal outcome at oocyte pick-up day in two patient groups. Optimal outcome of stimulation is defined as 10 oocytes collected in the group of patients matching the inclusion criteria of the study.
The control group receives starting hormone dosage assigned by the clinician according to standard clinical procedures. The intervention group receives starting hormone dosage adjusted according to the results of the Gonadotropin Removal Test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stimulation according to the mid-luteal phase gonadotropin-releasing hormone-agonist protocol
- •Pre-selected starting dose <110 IU or >270 IU FSH
排除标准
- •Risk for hyperstimulation
- •Polycystic ovary syndrome
- •Endometriosis stage >III
- •Anti-mullerian hormone value missing
研究组 & 干预措施
Intervention
Hormone dosage is calculated by using the new method Gonadotropin removal test.
干预措施: Gonadotropin removal test (Other)
Routine IVF method
Hormone dosage is chosen by the clinician according to standard clinical routine.
干预措施: Routine IVF method (Other)
结局指标
主要结局
Consistency of optimal ovarian response during stimulation.
时间窗: The day of follicle aspiration.
Difference from optimal ovarian response (defined as 10 oocytes collected) is calculated for each patient. Variance of these differences is compared between treatment and control groups.
Deviation from optimal ovarian response, defined as 10 oocytes collected during transvaginal follicle aspiration
时间窗: The day of follicle aspiration.
Difference from optimal ovarian response (defined as 10 oocytes collected) is calculated for each patient. The mean these differences is compared between treatment and control groups.
次要结局
未报告次要终点
研究者
Peter Zoltan Fedorcsak
Head of Department
Oslo University Hospital