Evaluation of the Ovarian Reserve in Patients Who Hypogastric Arteries and or Uterine Arteries Had Been Ligated

• Sponsor: Ege University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02995343
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 34
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Ovarian Reserve; Hypogastric Artery Ligation; Uterine Artery Ligation	Procedure: Hypogastric and/or uterine artery ligation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Study Start Date: Nov 1, 2016
• Anticipated Primary Completion Date: Aug 1, 2019
• Anticipated Study Completion Date: Sep 1, 2019

Arms and Interventions

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	Procedure: Hypogastric and/or uterine artery ligation
No Intervention: Normal postpartum women

Outcome Measures

Primary Outcome Measures

1. Anti-mullerian hormone levels will be evaluated [6 months after surgery and delivery]

2. Antral Follicule Count will be evaluated [6 months after surgery and delivery]

3. Ovarian volume will be evaluated [6 months after surgery and delivery]

4. Follicule Stimuli Hormone levels will be evaluated [6 months after surgery and delivery]

5. Estrogen levels will be evaluated [6 months after surgery and delivery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ege University, Medicine Faculty, Department of Obstetrics and Gynecology	Izmir		Turkey	35100

Sponsors and Collaborators

• Ege University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cagdas Sahin, MD, Ege University
• ClinicalTrials.gov Identifier: NCT02995343
• Other Study ID Numbers: 2.100.2014.0076
• First Posted: Dec 16, 2016
• Last Update Posted: Mar 28, 2019
• Last Verified: Mar 1, 2019

Study Results

No Results Posted as of Mar 28, 2019