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NCT05029817 Clinical Trial

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

Cystic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05029817
Other study ID # HMO-0298-21
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 15, 2021
Est. completion date December 2021

Study information
Verified date August 2021
Source Hadassah Medical Organization
Contact Keren Marks-Garber, MD
Phone 00 927 2 5844454
Email kerenmar@hadassah.org.il
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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).

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Hadassah Medical Organization, Jerusalem, Israel Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary AMH levels Levels of Anti-Mullerian hormone 24 hours
Primary Antral follicular count Antral follicular count as assessed by ultrasound Through study completion, an average of 1 year.
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