Healthy
Conditions
Keywords
ovarian stimulation, cortisol, cortisone
Brief summary
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.
Interventions
PROCEDURETime of OPU
OPU procedure either at 8 am or 8 pm
Sponsors
ART Fertility Clinics LLC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the concentration of cortisol and cortisone in serum and follicular fluid samples collected at 8 am versus collection at 8 p.m. | From enrollment to the end of treatment at 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United Arab Emirates
Contacts
CONTACTJonalyn Edades, EMBA
CONTACTBarbara Lawrenz, PhD
Outcome results
None listed