Cystic FibrosisNCT05029817
Ovarian Reserve in Women With Cystic Fibrosis and the Correlation With Demographic and Clinical Parameters
An observational study of Cystic Fibrosis and Infertility, Female, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The main objective of this study is to assess the ovarian reserve of CF patients via measurement of AMH and AFC. Secondly, we aim to correlate between the ovarian reserve and demographic and clinical characteristics of these patients. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cystic Fibrosis, Infertility, Female
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Jul 2021to Dec 2021
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Female CF patients seen regularly in the Hadassah Mt. Scopus CF Center, aged 18-45 years old, who regularly attended the clinic, and from whom demographic and clinical parameters are available.
Who may be able to join
- Female patients diagnosed with CF according to genetic testing.
- Age 18-45 years old.
- Routinely attended the CF Center at Hadassah Medical Center.
Who cannot join
- Refusal to participate in the study.
- Age under 18 or above 45.
- Use of hormonal contraceptives (for the purpose of AFC).
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization, Jerusalem, Israel
Jerusalem
Hadas Lemberg, PhD, 00 972 2 6777572, lhadas@hadassah.org.il
About this study
The main objective of this study is to assess the ovarian reserve of CF patients via measurement of AMH and AFC. Secondly, we aim to correlate between the ovarian reserve and demographic and clinical characteristics of these patients.
Outcomes measured will be levels of AMH and AFC, as compared to standard means in the general population. There is no need for a control group in this study since the standardized means of AMH and AFC in the general population are a more accurate comparable measure, which is based on data collected from large-scale populations, and thus accounts for confounding age factor in a more complete manner than can be obtained via a control group (Almog et al., 2011, La Marca et al., 2012, Penzias et al., 2020).
- Conditions
- Cystic Fibrosis, Infertility, Female
- Keywords
- Antral follicular count, Anti-Mullerian hormone
- Medical subject headings
- Cystic Fibrosis, Infertility, Female
What is being measured
The primary outcome is the main question the study is designed to answer.
AMH levels
Levels of Anti-Mullerian hormone
Measured: 24 hours
Antral follicular count
Antral follicular count as assessed by ultrasound
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start15 Jul 2021
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anat Hershko Klement, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029817
- Sponsor's protocol ID
- HMO-0298-21
- Status last verified
- Aug 2021
- First submitted
- 21 Aug 2021
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovarian Reserve in Women With Cystic Fibrosis and the Correlation With Demographic and Clinical Parameters
- ClinicalTrials.gov ID
- NCT05029817
- Acronym / sponsor ID
- HMO-0298-21
- Conditions
- Cystic Fibrosis, Infertility, Female
- Keywords
- Antral follicular count, Anti-Mullerian hormone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 1 Sep 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.
The main objective of this study is to assess the ovarian reserve of CF patients via measurement of AMH and AFC. Secondly, we aim to correlate between the ovarian reserve and demographic and clinical characteristics of these patients.
Outcomes measured will be levels of AMH and AFC, as compared to standard means in the general population. There is no need for a control group in this study since the standardized means of AMH and AFC in the general population are a more accurate comparable measure, which is based on data collected from large-scale populations, and thus accounts for confounding age factor in a more complete manner than can be obtained via a control group (Almog et al., 2011, La Marca et al., 2012, Penzias et al., 2020).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Female CF patients seen regularly in the Hadassah Mt. Scopus CF Center, aged 18-45 years old, who regularly attended the clinic, and from whom demographic and clinical parameters are available.
Key inclusion criteria (3 listed)
- Female patients diagnosed with CF according to genetic testing.
- Age 18-45 years old.
- Routinely attended the CF Center at Hadassah Medical Center.
Key exclusion criteria (3 listed)
- Refusal to participate in the study.
- Age under 18 or above 45.
- Use of hormonal contraceptives (for the purpose of AFC).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
AMH levels
Time frame: 24 hours
Levels of Anti-Mullerian hormone
Antral follicular count
Time frame: Through study completion, an average of 1 year.
Antral follicular count as assessed by ultrasound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
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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.
Anat Hershko Klement, MD principal investigator
Hadassah Medical Organization
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 Cystic Fibrosis and Infertility, Female, run by Hadassah Medical Organization at 1 site in Israel.
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 3 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: status not confirmed, as of the sponsor's last update on 1 Sep 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keren Marks-Garber, MD (00 927 2 5844454, kerenmar@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AMH levels (time frame: 24 hours). The study lists 2 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 1 Sep 2021.