Serum AMH Levels in Patients Who Underwent Hypogastric Artery Ligation

September 29, 2017 updated by: Berna Aslan Cetin, Kanuni Sultan Suleyman Training and Research Hospital

Serum Antimullerian Hormone Levels in Patients Who Underwent Hypogastric Artery Ligation

To observe the effects of hypogastric artery ligation on serum antimullerian hormone levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To measure and compare serum antimullerian hormone levels in patients who underwent hypogastric artery ligation/ hypogastric artery ligation+ hysterectomy and postpartum control. The procedures performed as an emergency life saving method during delivery. The reasons for hypogastric artery ligation/ hypogastric artery ligation+ hysterectomy were obstetric hemorrhage mainly uterine atony.

The serum levels of antimullerian hormone were measured 6 months after the operations and compared with matching postpartum controls. Serum levels of FSH, LH, PRL and TSH were also measured 6 months after the operation. Further, antral follicle count measured along with the aforementioned blood tests.

Study Type

Observational

Enrollment (Actual)

90

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

  • Turkey
      • İstanbul, Turkey, 34303
        • Kanuni SSTRH

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

Sampling Method

Non-Probability Sample

Study Population

Patients who had hypogastric artery ligation and/or hysterectomy during their delivery. Control group is age-matched postpartum patients.

Description

Inclusion Criteria:

  • age 18- 40 years
  • no systemic or endocrine diseases
  • patients who had hypogastric artery ligation and/or hysterectomy
  • healthy postpartum patients as controls

Exclusion Criteria:

  • history of chemotherapy and/or radiotherapy
  • Obese patients
  • patients with previous/present endometriosis
  • patients with PCOS

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hypogastric artery ligation (HAL)
Patients who underwent only hypogastric artery ligation performed during the delivery of their babies. Six months after the operation they will evaluated for their ovarian reserve via hormones and astral follicle count (AFC)
Procedure: hypogastric artery ligation
hypogastric artery ligation is the ligation of the internal iliac artery to stop bleeding related to obstetrics obstetric hemorrhage Hysterectomy is the removal of the uterus if bleeding can't stop by hypogastric artery ligation
Other Names:
  • hysterectomy
HAL and hysterectomy
Patients who underwent both hypogastric artery ligation and hysterectomy performed during the delivery of their babies. Six months after the operation they will evaluated for their ovarian reserve via hormones and astral follicle count (AFC)
Procedure: hypogastric artery ligation
hypogastric artery ligation is the ligation of the internal iliac artery to stop bleeding related to obstetrics obstetric hemorrhage Hysterectomy is the removal of the uterus if bleeding can't stop by hypogastric artery ligation
Other Names:
  • hysterectomy
Postpartum
Postpartum control group constituted of patients delivered baby without any complication and evaluated 6 months later.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ovarian reserve
Time Frame: 6 months
To evaluate postoperative ovarian reserve using anti-mullerian hormones and other ovary related hormones including FSH,LH
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Investigators

  • Study Director: Alev Atıs, MD,ObGyn, Kanuni Sultan Suleyman Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Actual)

March 20, 2017

Primary Completion (Actual)

September 20, 2017

Study Completion (Actual)

September 29, 2017

Study Registration Dates

First Submitted

July 14, 2017

First Submitted That Met QC Criteria

July 14, 2017

First Posted (Actual)

July 18, 2017

Study Record Updates

Last Update Posted (Actual)

October 2, 2017

Last Update Submitted That Met QC Criteria

September 29, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1826

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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