Anti-Mullerian Hormone DeficiencyNCT06999291
Ovarian Reserve in Intensive Care Patients
An observational study of Anti-Mullerian Hormone Deficiency, run by Haseki Training and Research Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Anti-Mullerian Hormone Deficiency
- What is being tested?
- Glaskow coma scala, The Acute Physiology and Chronic Health Evaluation System- APACHE, Injury Severity Score- ISS)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2025to 15 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: a group of healthy women without any disease and a group of patients hospitalized in intensive care unit.
Who may be able to join
- 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,
Who cannot join
- 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,
Show all 10Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Ovarian Reserve in Critically Ill Patients Followed in the Intensive Care Unit
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.
- Conditions
- Anti-Mullerian Hormone Deficiency
- Being tested
- Glaskow coma scala, The Acute Physiology and Chronic Health Evaluation System- APACHE, Injury Severity Score- ISS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glaskow coma scala, The Acute Physiology and Chronic Health Evaluation System- APACHE, Injury Severity Score- ISS)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| internal intensive care | Patients hospitalized in intensive care for internal reasons Receives: 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 Receives: 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 Receives: Behavioral: Glaskow coma scala, The Acute Physiology and Chronic Health Evaluation System- APACHE, Injury Severity Score- ISS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ovarian follicle count
Ovarian reserve will be checked with ultrasound
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start15 Jun 2025 (estimated)
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anti-Mullerian Hormone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Yilmaz Guler, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999291
- Sponsor's protocol ID
- OR-2024
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36606666Moolhuijsen 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.
PubMed 32770239
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ovarian Reserve in Critically Ill Patients Followed in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06999291
- Acronym / sponsor ID
- OR-2024
- Conditions
- Anti-Mullerian Hormone Deficiency
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| internal intensive care | – | Behavioral: Glaskow coma scala, The Acute Physiology and Chronic Health Evaluation System- APACHE, Injury Severity Score- ISS)Patients hospitalized in intensive care for internal reasons |
| surgical intensive care | – | Behavioral: Glaskow coma scala, The Acute Physiology and Chronic Health Evaluation System- APACHE, Injury Severity Score- ISS)Patients hospitalized in intensive care for surgical reasons |
| Outpatient clinic patients | – | Behavioral: Glaskow coma scala, The Acute Physiology and Chronic Health Evaluation System- APACHE, Injury Severity Score- ISS)Healthy female patients admitted to gynecology outpatient clinic |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- a group of healthy women without any disease and a group of patients hospitalized in intensive care unit.
Key inclusion criteria (3 listed)
- 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,
Key exclusion criteria (10 listed)
- Previous ovarian surgery, endometriosis, endometrioma,
- History of chemotherapy, radiotherapy,
- Ovarian cyst, malignancy and other ovarian pathologies,
- Women with single ovary,
- Women receiving hormone therapy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Outpatient clinic patients, internal intensive care, surgical intensive care |
Primary outcome
ovarian follicle count
Time frame: 24 hour
Ovarian reserve will be checked with ultrasound
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Results publication: PubMed 36606666Kayambankadzanja 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.
- Results publication: PubMed 32770239Moolhuijsen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Anti-Mullerian Hormone Deficiency, run by Haseki Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact emine yılmaz güler (905054525261, dr.emine.yilmaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ovarian follicle count (time frame: 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06999291, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.