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
• Status: Recruiting
• 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
• 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).

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Infertility
• Infertility, Female

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.