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

Sponsor
Hadassah Medical Organization (Other)
Overall Status
Recruiting
CT.gov ID
NCT05029817
Collaborator
(none)
30
Enrollment
1
Location
4.6
Anticipated Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Ovarian Reserve in Women With Cystic Fibrosis and the Correlation With Demographic and Clinical Parameters
    Actual Study Start Date :
    Jul 15, 2021
    Anticipated Primary Completion Date :
    Dec 1, 2021
    Anticipated Study Completion Date :
    Dec 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. AMH levels [24 hours]

      Levels of Anti-Mullerian hormone

    2. Antral follicular count [Through study completion, an average of 1 year.]

      Antral follicular count as assessed by ultrasound

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hadassah Medical Organization, Jerusalem, Israel Jerusalem Israel

    Sponsors and Collaborators

    • Hadassah Medical Organization

    Investigators

    • Principal Investigator: Anat Hershko Klement, MD, Hadassah Medical Organization

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hadassah Medical Organization
    ClinicalTrials.gov Identifier:
    NCT05029817
    Other Study ID Numbers:
    • HMO-0298-21
    First Posted:
    Sep 1, 2021
    Last Update Posted:
    Sep 1, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hadassah Medical Organization
    Antral follicular count
    Anti-Mullerian hormone
    Additional relevant MeSH terms:
    Cystic Fibrosis
    Infertility
    Infertility, Female
    Fibrosis

    Study Results

    No Results Posted as of Sep 1, 2021