Ovarian Reserve in Women With Cystic Fibrosis and the Correlation With Demographic and Clinical Parameters

NCT ID: NCT05029817

Last Updated: 2021-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-15

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cystic Fibrosis Infertility, Female

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Female patients diagnosed with CF according to genetic testing.
* Age 18-45 years old.
* Routinely attended the CF Center at Hadassah Medical Center.

Exclusion Criteria

* Refusal to participate in the study.
* Age under 18 or above 45.
* Use of hormonal contraceptives (for the purpose of AFC).
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anat Hershko Klement, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, , Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Keren Marks-Garber, MD

Role: CONTACT

00 927 2 5844454

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hadas Lemberg, PhD

Role: primary

00 972 2 6777572

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HMO-0298-21

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Genetic Epidemiology of Ovarian Aging
NCT00501800 ACTIVE_NOT_RECRUITING
Gender Disparity and Hormones in Cystic Fibrosis
NCT02036879 COMPLETED EARLY_PHASE1