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NCT Number: NCT06877429

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

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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Time of OPU

Procedure

OPU procedure either at 8 am or 8 pm

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

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara Lawrenz, PhD

CONTACT

[email protected]

+97126528000

Jonalyn Edades, EMBA

CONTACT

[email protected]

+97126528000

Sponsors and collaborators

Lead sponsor

ART Fertility Clinics LLC

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 14, 2025
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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