NCT06999291

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 31, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

June 15, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2025

Completed
Last Updated

May 31, 2025

Status Verified

May 1, 2025

Enrollment Period

1 month

First QC Date

May 7, 2025

Last Update Submit

May 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • ovarian follicle count

    Ovarian reserve will be checked with ultrasound

    24 hour

Study Arms (3)

internal intensive care

Patients hospitalized in intensive care for internal reasons

Behavioral: Glaskow coma scala, The Acute Physiology and Chronic Health Evaluation System- APACHE, Injury Severity Score- ISS)

surgical intensive care

Patients hospitalized in intensive care for surgical reasons

Behavioral: Glaskow coma scala, The Acute Physiology and Chronic Health Evaluation System- APACHE, Injury Severity Score- ISS)

Outpatient clinic patients

Healthy female patients admitted to gynecology outpatient clinic

Behavioral: Glaskow coma scala, The Acute Physiology and Chronic Health Evaluation System- APACHE, Injury Severity Score- ISS)

Interventions

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.

Outpatient clinic patientsinternal intensive caresurgical intensive care

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

a group of healthy women without any disease and a group of patients hospitalized in intensive care unit.

You may qualify if:

  • 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,

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Interventions

Injury Severity Score

Intervention Hierarchy (Ancestors)

Trauma Severity IndicesMedical RecordsRecordsData CollectionEpidemiologic MethodsInvestigative TechniquesOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Central Study Contacts

emine yılmaz güler

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 7, 2025

First Posted

May 31, 2025

Study Start

June 15, 2025

Primary Completion

July 15, 2025

Study Completion

November 15, 2025

Last Updated

May 31, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share