- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02995343
Evaluation of the Ovarian Reserve in Patients Who Hypogastric Arteries and or Uterine Arteries Had Been Ligated
March 26, 2019 updated by: Cagdas Sahin, Ege University
Patients who hypogastric arteries and/or uterine arteries had been ligated will be evaluated in terms of ovarian reserve markers such as anti-mullerian hormone levels, ovarian volumes, antral follicule count, follicule stimuli hormone and estrogen levels.
Investigators will search their archives for finding suitable patients for study.
Investigators will especially notice being at least 6 month time of interval between surgery and evaluation time.
Ultrasound examination and taking blood sample will be performed on 2nd or 3th day of menstrual cycle.
These results will be compared with normal postpartum women's results.
It will be evaluated that there is or not any effect of the hypogastric arteries and/or uterine arteries on ovarian reserve
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Izmir, Turkey, 35100
- Recruiting
- Ege University, Medicine Faculty, Department of Obstetrics and Gynecology
-
Contact:
- cagdas sahin, MD
- Phone Number: +905324676106
- Email: cagdasdr@yahoo.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Patients had been ligated hypogastric and/or uterine arteries
- Patients are in 6 month period after surgery
- Without performed hysterectomy
- No older than 40 years old
- No history about endocrinopathy which have an effect upon ovarian reserve
Exclusion Criteria:
- Patients had been made other gynecologic surgery such as fallopian tube ligation and hysterectomy etc.
- Patients are older than 40 years old
- Patients use drugs which have an effect upon ovarian reserve
- Patients have diseases which have an effect upon ovarian reserve such as some endocrinopathy, malign diseases which require radiotherapy and chemotherapy etc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hypogastric and/or uterine artery ligation
Patients who had been ligated hypogastric artery and or uterine artery for ceasing uterine bleeding during c-section
|
|
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No Intervention: Normal postpartum women
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Anti-mullerian hormone levels will be evaluated
Time Frame: 6 months after surgery and delivery
|
6 months after surgery and delivery
|
|
Antral Follicule Count will be evaluated
Time Frame: 6 months after surgery and delivery
|
6 months after surgery and delivery
|
|
Ovarian volume will be evaluated
Time Frame: 6 months after surgery and delivery
|
6 months after surgery and delivery
|
|
Follicule Stimuli Hormone levels will be evaluated
Time Frame: 6 months after surgery and delivery
|
6 months after surgery and delivery
|
|
Estrogen levels will be evaluated
Time Frame: 6 months after surgery and delivery
|
6 months after surgery and delivery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2016
Primary Completion (Anticipated)
August 1, 2019
Study Completion (Anticipated)
September 1, 2019
Study Registration Dates
First Submitted
December 12, 2016
First Submitted That Met QC Criteria
December 13, 2016
First Posted (Estimate)
December 16, 2016
Study Record Updates
Last Update Posted (Actual)
March 28, 2019
Last Update Submitted That Met QC Criteria
March 26, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 2.100.2014.0076
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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