Current partner codePEPTIDESDE
NCT06877429·Not applicable·OBSERVATIONAL

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

Status

Not yet recruiting

Phase

Not applicable

Enrollment

20

Locations

1

Results

Not posted

Publications

5

Study summary

What the protocol is testing.

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

Treatment arms and agents.

PROCEDURE

Time of OPU

OPU procedure either at 8 am or 8 pm

Timeline

From registration to results.

  1. First posted

    Mar 14, 2025

  2. Study start

    Dec 30, 2026

  3. Primary completion

    Apr 30, 2027

  4. Study completion

    Dec 31, 2027

  5. Results posted

    Not reported

  6. Registry updated

    May 7, 2026

Outcomes

What the study measures.

Primary outcomes

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

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
35 Years
Sex
FEMALE
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

Study locations

1 registered sites.

United Arab Emirates. Showing up to 24 locations stored in the fast local snapshot.

ART Fertility Clinics LLC

Abu Dhabi, United Arab Emirates

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