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Not yet recruiting NCT06999291

Ovarian Reserve in Intensive Care Patients

Observational Anti-Mullerian Hormone Deficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Glaskow coma scala, The Acute Physiology and Chronic Health Evaluation System- APACHE, Injury Severity Score- ISS).
Who it may be relevant to
Registry conditions: Anti-Mullerian Hormone Deficiency. Basic parameters: 18 years — 35 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of Ovarian Reserve in Critically Ill Patients Followed in the Intensive Care Unit

Overview

Gastrointestinal, pulmonary, nephrological, cardiac, neurologic and psychological effects in critically ill patients followed in the intensive care unit have been shown in the literature. However, the effects on ovarian reserve in these patients have not been sufficiently investigated and studies investigating this issue are limited in the literature. The synthesis, release frequency and amplitude of reproductive hormones change under stress. In addition, changes in ovarian homeostasis affect ovarian reserve. The aim of this study was to evaluate ovarian reserve in critically ill patients followed up in the intensive care unit.

Interventions

  • Behavioral Glaskow coma scala, The Acute Physiology and Chronic Health Evaluation System- APACHE, Injury Severity Score- ISS)
    The uterus, endometrium and ovarian characteristics, endometrial thickness, ovarian follicle number and ovarian volume parameters, hormone panel (FSH, LH, E2, AMH), cortisol, prolactin and thyroid function tests routinely examined for ovarian reserve will be evaluated in the study.

Primary outcome measures

  • ovarian follicle count [Time frame: 24 hour]

Eligibility criteria

Inclusion criteria

  • 18-35 years of age
  • Female patients followed in the intensive care unit for more than 24 hours for internal or surgical reasons,
  • Women whose ovarian reserve is being evaluated,

Exclusion criteria

  • Previous ovarian surgery, endometriosis, endometrioma,
  • History of chemotherapy, radiotherapy,
  • Ovarian cyst, malignancy and other ovarian pathologies,
  • Women with single ovary,
  • Women receiving hormone therapy,
  • Polycystic ovary syndrome,
  • Surgical intervention within the last 6 months,
  • History of drug, alcohol, substance use,
  • Women in pregnancy, puerperium, lactation,
  • History of vaccination within the last 6 months

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Kayambankadzanja RK, Schell CO, Gerdin Warnberg M, Tamras T, Mollazadegan H, Holmberg M, Alvesson HM, Baker T. Towards definitions of critical illness and critical care using concept analysis. BMJ Open. 2022 Sep 5;12(9):e060972. doi: 10.1136/bmjopen-2022-060972. PMID 36606666
  • Moolhuijsen LME, Visser JA. Anti-Mullerian Hormone and Ovarian Reserve: Update on Assessing Ovarian Function. J Clin Endocrinol Metab. 2020 Nov 1;105(11):3361-73. doi: 10.1210/clinem/dgaa513. PMID 32770239

Identifiers

NCT: NCT06999291 · OR-2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗