Is the Diurnal Variation in Circulating Levels of Cortisol Reflected in Follicular Fluid of Preovulatory Follicles Close to Ovulation?
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Evaluate the concentration of cortisol and cortisone in serum and follicular fluid samples collected at 8 am versus collection at 8 p.m.
研究概览
简要总结
Glucocorticoids and especially cortisol exhibit a pronounced diurnal variation. Levels peak around 8 am and may decrease around two to three times during the day reaching a nadir during the evening and early in the night.
Ovulation has been described as a controlled inflammatory event. Following release of the oocyte, termination of the inflammatory reaction needs to take place in order for the follicle and the developing corpus luteum to avoid further damage. It has been suggested, that locally enhanced cortisol availability may play a role in limiting tissue damage and by acting as anti-inflammatory agents mediating repair and remodeling. The aim of the present study is evaluate the concentration of cortisol and cortisone in sets of serum and follicular fluid samples collected simultaneous and at different times of the day (8.00 a.m. and 8.00 p.m.) and compare the levels with the time of the day at which they are collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Indication for IVF / ICSI - treatment
- •Age ≥ 18 years and ≤ 35 years
- •Body weight: 19 - 29 kg/m2
- •Ovarian reserve parameters in the adequate age - range, determined by Anti-Muellerian-Hormone (AMH) and Antral Follicle Count (AFC) (Shebl 2011, Hamdine 2015)
- •Regular cycle (25-35 days)
排除标准
- •Age < 18 years and > 35 years
- •Body weight < 60 kg and > 90 kg
- •Ovarian reserve parameters outside the adequate age - range, determined by Anti-Muellerian-Hormone (AMH) and Antral Follicle Count (AFC) (Shebl 2011, Hamdine 2015)
- •Proven poor responder in preceding IVF-treatment-cycle, according to the Bologna criteria: at least two of the following three features must be present:
- •(i) Advanced maternal age (≥40 years) or any other risk factor for POR (poor ovarian response) (ii) A previous POR (≤3 oocytes with a conventional stimulation protocol) (iii) An abnormal ovarian reserve test (i.e. AFC < 5-7 follicles or AMH < 0.5 -1.1 ng/ml)
- •Two episodes of POR after maximal stimulation are sufficient to define a patient as a poor responder in the absence of advanced maternal age or abnormal ORT
- •Diagnosis of polycystic ovarian syndrome (PCOS), according to Rotterdam criteria
- •Endometriosis stage 3 or 4 AFS (American Fertility Society)
- •Irregular cycle (< 25 days and > 35 days)
- •Treatment with GnRH-analogues during the previous 6 months
- •Intake of contraceptive pill (OCP) or any hormonal treatment during the last 3 months
研究组 & 干预措施
Group A: will have oocyte retrieval at 8.00 a.m.
Ovarian stimulation for both groups (Group A and B): 150 mcg Corifollitropin-Alpha (Elonva®, MSD) will be started in the afternoon of day 2/3 of the cycle. To inhibit premature LH surge, daily GnRH - antagonist (Orgalutran® 0,25mg, NV Organon) will be administered from the morning of day 6 of stimulation. From day 8 onwards, recFSH (Puregon, NV, The Netherlands) will be started and the dosage will be adjusted to the patients response. Final oocyte maturation will be achieved by administration of a dual trigger (5.000 IU of HCG (Pregnyl®,NV Organon) plus 0.3 mg of GnRH-agonist) as soon as ≥ 3 follicles ≥ 17 mm are present.
In case that patients are at risk of ovarian hyperstimulation (OHSS), defined as more than 20 follicles above 12 mm, patients will NOT receive hCG but only GnRH-agonist as trigger medication.
Oocyte retrieval will be carried out 36 hours after HCG administration. Previous studies have described ICSI and IVF procedures in detail (Van Steirteghem et al, 1993; Devroey
干预措施: Time of OPU (Procedure)
Group B: will have oocyte retrieval at 8.00 p.m.
Ovarian stimulation for both groups (Group A and B): 150 mcg Corifollitropin-Alpha (Elonva®, MSD) will be started in the afternoon of day 2/3 of the cycle. To inhibit premature LH surge, daily GnRH - antagonist (Orgalutran® 0,25mg, NV Organon) will be administered from the morning of day 6 of stimulation. From day 8 onwards, recFSH (Puregon, NV, The Netherlands) will be started and the dosage will be adjusted to the patients response. Final oocyte maturation will be achieved by administration of a dual trigger (5.000 IU of HCG (Pregnyl®,NV Organon) plus 0.3 mg of GnRH-agonist) as soon as ≥ 3 follicles ≥ 17 mm are present.
In case that patients are at risk of ovarian hyperstimulation (OHSS), defined as more than 20 follicles above 12 mm, patients will NOT receive hCG but only GnRH-agonist as trigger medication.
Oocyte retrieval will be carried out 36 hours after HCG administration. Previous studies have described ICSI and IVF procedures in detail (Van Steirteghem et al, 1993; Devroey
干预措施: Time of OPU (Procedure)
结局指标
主要结局
Evaluate the concentration of cortisol and cortisone in serum and follicular fluid samples collected at 8 am versus collection at 8 p.m.
时间窗: From enrollment to the end of treatment at 8 weeks
次要结局
- Evaluate the concentration of sex-steroids and cortisol metabolites in follicular fluid samples collected at 8 am versus collection at 8 p.m.(From enrollment to the end of treatment at 8 weeks)
研究者
Barbara Lawrenz
Research Director
ART Fertility Clinics LLC