The Early Luteal Progesterone Profile in IVF Patients Triggered With hCG - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- change in serum concentrations of luteinizing hormone
研究概览
简要总结
This pilot-study will help characterize the serum progesterone profiles in IVF patients and correlate progesterone levels to ovarian follicles obtained after stimulation with exogenous gonadotropins.
详细描述
The early luteal progesterone profile in IVF differs significantly from the progesterone profile of the natural cycle, in which the peak is reached around the time of implantation. With this non-invasive trial investigators wish to further explore the early luteal phase profiles of progesterone and hCG in order to optimize current luteal phase support policies in IVF and hopefully increase ongoing pregnancy rates.
Stimulation, monitoring, and oocyte pick-up will be performed according to the standard procedure of the clinic. On the day of trigger with 5.000 IU hCG a blood sample will be drawn prior to triggering for subsequent analysis. Moreover, all ovarian follicles on each side equal to or above 11 mm will be registered. Oocyte pick-up and timing of the trigger bolus will be performed according to the standard procedures of the unit.
A total 10 blood samples will be drawn during this trial - please see "blood sampling". Blood samples will be collected on the following days for subsequent analysis of LH, E2, hCG and progesterone.
All embryos will be cryo-preserved for transfer in subsequent frozen/thaw embryo transfer cycles.
Primary endpoint Serum concentrations of progesterone, LH, E2, and hCG during early luteal phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •IVF patients who meet the following criteria:
- •Freeze all cycle after hCG trigger
- •Age 18 - 38
- •Body Mass Index (BMI) < 28kg/m2
- •Normal ovarian reserve, defined by Anti-Mullerian Hormone (AMH) > 1.25 ng/ml or Antral Follicle Count (AFC) ≥ 6 measured within two months prior to stimulation start
- •Receiving Gonadotropin Releasing Hormone Antagonist co-treatment during ovarian stimulation
- •Agreement to participate in the study, and to disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study.
- •Have given written informed consent with the understanding that the subject may withdraw consent at any time without prejudice to future medical care.
排除标准
- •Previous poor response (≤ 3 oocytes) after high dose FSH stimulation
- •Hyper-response defined as >20 follicles ≥ 14 mm
- •Chronical medical conditions like Diabetes, Crohns disease, Thyroid disease, Hepatitis B and Sexually Transmitted Diseases Simultaneous participation in an interventional clinical trial.
研究组 & 干预措施
hormonal levels
Blood samples are collected for analysis of LH, E2, hCG and progesterone.
干预措施: blood collection (Other)
结局指标
主要结局
change in serum concentrations of luteinizing hormone
时间窗: in 6 days after hCG injection
Blood samples are collected at ten points of time.
change in serum concentrations of progesterone
时间窗: in 6 days after human chorionic gonadotropin injection
Blood samples are collected at ten points of time.
change in serum concentrations of estradiol
时间窗: in 6 days after hCG injection
Blood samples are collected at ten points of time.
change in serum concentrations of hCG
时间窗: in 6 days after hCG injection
Blood samples are collected at ten points of time.
次要结局
- number of follicles larger than 11 millimeters(on the day of hCG injection)
研究者
Manh Tuong Ho
Doctor
Vietnam National University