Is the Diurnal Variation in Circulating Levels of Cortisol Reflected in Follicular Fluid of Preovulatory Follicles Close to Ovulation?

ConditionHealthy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-35
SponsorART Fertility Clinics LLC

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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)

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

Trial population

Healthy women

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Time of OPU

    Procedure/Surgery

    OPU procedure either at 8 am or 8 pm

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Group A: will have oocyte retrieval at 8.00 a.m.1 intervention
Group B: Group B: will have oocyte retrieval at 8.00 p.m.1 intervention

Trial outcomes

Primary outcomes

1

Evaluate the concentration of cortisol and cortisone in serum and follicular fluid samples collected at 8 am versus collection at 8 p.m.

Time frame
From enrollment to the end of treatment at 8 weeks

Secondary outcomes

1

Evaluate the concentration of sex-steroids and cortisol metabolites in follicular fluid samples collected at 8 am versus collection at 8 p.m.

Time frame
From enrollment to the end of treatment at 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: