Anti-Mullerian Hormone DeficiencyNCT04762615
Impact of Underlying Renal Disease and Immunosuppressive Regimen on Ovarian Reserve in Renal Patients
An observational study of Anti-Mullerian Hormone Deficiency and Immunosuppression, run by Wroclaw Medical University at 1 site in Poland.
Trial summary
Aging, renal pathology (eg SLE, ADPKD), X-ray exposition and pharmacological treatments, especially previous strong immunosuppression, may negatively influence the ovarian reserve in childbearing age women. Anti-Müllerian hormone (AMH) is regarded as biomarker for ovarian reserve. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Anti-Mullerian Hormone Deficiency, Immunosuppression, Ovarian Reserve
- What is being tested?
- AMH level measurement
- How many people
- 153 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2018to 1 Dec 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 44 years
- Women only
- No healthy volunteers
- Adult
Study population: Regularly menstruating female patients suffering from renal pathology or after renal transplantation
Who may be able to join
- Conscious written approval
- Autoimmunological disorder with kidneys affection/ kidney transplant recipient- Regular menstrual cycles
- Age above 18 years old
Who cannot join
- Irregular menstrual cycles
- Menopause
- PCOS
- Chemiotherapy or radiotherapy in the past
- Surgical interventions within ovaries
- Hypogonadotropic hypogonadism
- Folliculoma
- Age under 18 years old
Trial locations and contacts
1 site in 1 country.
Poland1 site
Nephrology and Transplantation Clinic University Hospital in Wrocław
Wroclaw, 50-556
About this study
Official title: Impact of the Immunosuppressive Treatment, X-ray Exposition and Renal Pathology on Ovarian Reserve in Young Women
Aging, renal pathology (eg SLE, ADPKD), X-ray exposition and pharmacological treatments, especially previous strong immunosuppression, may negatively influence the ovarian reserve in childbearing age women. Anti-Müllerian hormone (AMH) is regarded as biomarker for ovarian reserve.
Every female with renal disease regularly menstruating that met exclusion criteria could have participated. The aim was to assess ovarian reserve in female patients with normal menstrual cycle and kidney disease, including kidney transplant recipients.
- Being tested
- AMH level measurement
- Keywords
- AMH, Immunosuppression, Ovarian Reserve, X-Ray effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMH level measurementDiagnostic test
AMH level measurement using ELISA test from blood samples
| Study group | Role | What they receive |
|---|---|---|
| Patients with renal pathology treated with immunosuppressive drugs | Female in reproductive age suffering from renal disease that is or was previously treated with immunosuppressive drugs Receives: Diagnostic Test: AMH level measurement | |
| Patients with renal pathology without treatment | Control group Receives: Diagnostic Test: AMH level measurement | |
| Patients after renal transplantation taking immunosuppressive drugs | Female in reproductive age after renal transplantation taking immunosuppressive drugs Receives: Diagnostic Test: AMH level measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare AMH levels between three groups
Serum AMH levels [ng/ml] measured using ELISA and compared between three groups
Measured: 1 day
Potential impact of X-ray exposition on ovarian reserve
Analysis of the impact of X-ray exposition [mSv] on AMH serum level [ng/ml]
Measured: 1 day
Potential impact of antiproliferative drugs on ovarian reserve
Analysis of the impact of antiproliferative drugs on AMH serum level [ng/ml]
Measured: 1 day
Potential impact of underlying kidney disease on ovarian reserve
Analysis of the impact of underlying kidney disease (including SLE) on AMH serum level [ng/ml]
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Jun 2018
- Primary completion10 Nov 2019
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 153 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia Rasała, MD, Principal investigator, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04762615
- Sponsor's protocol ID
- 451/2018
- Status last verified
- Dec 2020
- First submitted
- 2 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Immunosuppressive Treatment, X-ray Exposition and Renal Pathology on Ovarian Reserve in Young Women
- ClinicalTrials.gov ID
- NCT04762615
- Acronym / sponsor ID
- 451/2018
- Keywords
- AMH, Immunosuppression, Ovarian Reserve, X-Ray effects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 10 Nov 2019 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 21 Feb 2021 (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.
Aging, renal pathology (eg SLE, ADPKD), X-ray exposition and pharmacological treatments, especially previous strong immunosuppression, may negatively influence the ovarian reserve in childbearing age women. Anti-Müllerian hormone (AMH) is regarded as biomarker for ovarian reserve.
Every female with renal disease regularly menstruating that met exclusion criteria could have participated. The aim was to assess ovarian reserve in female patients with normal menstrual cycle and kidney disease, including kidney transplant recipients.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with renal pathology treated with immunosuppressive drugs | – | Diagnostic Test: AMH level measurementFemale in reproductive age suffering from renal disease that is or was previously treated with immunosuppressive drugs |
| Patients with renal pathology without treatment | – | Diagnostic Test: AMH level measurementControl group |
| Patients after renal transplantation taking immunosuppressive drugs | – | Diagnostic Test: AMH level measurementFemale in reproductive age after renal transplantation taking immunosuppressive drugs |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Regularly menstruating female patients suffering from renal pathology or after renal transplantation
Key inclusion criteria (3 listed)
- Conscious written approval
- Autoimmunological disorder with kidneys affection/ kidney transplant recipient- Regular menstrual cycles
- Age above 18 years old
Key exclusion criteria (8 listed)
- Irregular menstrual cycles
- Menopause
- PCOS
- Chemiotherapy or radiotherapy in the past
- Surgical interventions within ovaries
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 |
|---|---|---|
| AMH level measurementAMH level measurement using ELISA test from blood samples | Diagnostic test | Patients after renal transplantation taking immunosuppressive drugs, Patients with renal pathology treated with immunosuppressive drugs, Patients with renal pathology without treatment |
Primary outcome
To compare AMH levels between three groups
Time frame: 1 day
Serum AMH levels [ng/ml] measured using ELISA and compared between three groups
Potential impact of X-ray exposition on ovarian reserve
Time frame: 1 day
Analysis of the impact of X-ray exposition [mSv] on AMH serum level [ng/ml]
Potential impact of antiproliferative drugs on ovarian reserve
Time frame: 1 day
Analysis of the impact of antiproliferative drugs on AMH serum level [ng/ml]
Potential impact of underlying kidney disease on ovarian reserve
Time frame: 1 day
Analysis of the impact of underlying kidney disease (including SLE) on AMH serum level [ng/ml]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- 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. This study is not recruiting at the moment.
Julia Rasała, MD principal investigator
Wroclaw Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anti-Mullerian Hormone Deficiency and Immunosuppression, run by Wroclaw Medical University at 1 site in Poland.
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 8 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: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare AMH levels between three groups (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2021.