Serum Antimullerian Hormone Levels in Patients Who Underwent Uterine Artery Ligation

Investigators would like to see the amh values after uterine artery ligation

Study Overview

• Status: Completed
• Conditions: Ovarian Reserve; Uterine Artery Ligation
• Intervention / Treatment: Diagnostic test: Uterine artery ligation (UAL)

Detailed Description

Group/cohort:

Uterine artery ligation (UAL) Investigators would like to invite the patients to the hospital at least 6 months after surgery who underwent only uterine artery ligation performed due to uterine atony during C-section.

Participants would be evaluated for their ovarian reserve via hormones and antral follicle count (AFC)

Control Group:

Investigators would like to invite the patients to the hospital at least 6 months after C-section who delivered baby without any complication.

Participants would be also evaluated for their ovarian reserve via hormones and antral follicle count (AFC)

• Study Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• Turkey
  • İ̇stanbul
    • Istanbul, İ̇stanbul, Turkey, 34000
      • Pinar Yalcin Bahat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 33 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Patients who had uterine artery ligation during C-section. Control group is age-matched postpartum patients.

Description

Inclusion Criteria:

• age 18- 35 years
• no systemic or endocrine diseases
• patients who had uterine artery ligation due to atony
• healthy postpartum patients as controls

Exclusion Criteria:

• patients with PCOS

  • Pregnancy with IVF or oosit donation
  • Patients with endocrinopathy, diseases which require radiotherapy and chemotherapy etc.
  • Patients with BMI >40

Study Plan

How is the study designed?

Design Details

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

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Uterine artery ligation (UAL); We would like toinvite the patients to the hospital at least 6 months after surgery who underwent only uterine artery ligation performed due to uterine atony during C-section. They would be evaluated for their ovarian reserve via hormones and antral follicle count (AFC)	Diagnostic test: Uterine artery ligation (UAL); Uterine artery ligation (UAL) We will invite the patients to the hospital at least 6 months after surgery who underwent only uterine artery ligation performed due to uterine atony during C-section. They will evaluated for their ovarian reserve via hormones and antral follicle count (AFC)
Control Group: We would like to invite the patients to the hospital at least 6 months after C-section who delivered baby without any complication. They would be also evaluated for their ovarian reserve via hormones and antral follicle count (AFC)	Diagnostic test: Uterine artery ligation (UAL); Uterine artery ligation (UAL) We will invite the patients to the hospital at least 6 months after surgery who underwent only uterine artery ligation performed due to uterine atony during C-section. They will evaluated for their ovarian reserve via hormones and antral follicle count (AFC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1.ovarian reserve in patients with uterine artery ligation	calculation of ovarian reserve with amh (ng/ml) after uterine artery ligation due to uterine atony	12 months

Collaborators and Investigators

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: March 27, 2019
• First Submitted That Met QC Criteria: March 28, 2019
• First Posted (Actual): March 29, 2019

Study Record Updates

• Last Update Posted (Actual): March 29, 2019
• Last Update Submitted That Met QC Criteria: March 28, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Uterine atony; amh
• Other Study ID Numbers: uterinarter

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: 12 months
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No