NCT02995343

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 12, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 16, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

2.7 years

First QC Date

December 12, 2016

Last Update Submit

March 26, 2019

Conditions

Outcome Measures

Primary Outcomes (5)

  • Anti-mullerian hormone levels will be evaluated

    6 months after surgery and delivery

  • Antral Follicule Count will be evaluated

    6 months after surgery and delivery

  • Ovarian volume will be evaluated

    6 months after surgery and delivery

  • Follicule Stimuli Hormone levels will be evaluated

    6 months after surgery and delivery

  • Estrogen levels will be evaluated

    6 months after surgery and delivery

Study Arms (2)

Hypogastric and/or uterine artery ligation

EXPERIMENTAL

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

Normal postpartum women

NO INTERVENTION

Interventions

Hypogastric and/or uterine artery ligation

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University, Medicine Faculty, Department of Obstetrics and Gynecology

Izmir, 35100, Turkey (Türkiye)

RECRUITING

Central Study Contacts

cagdas sahin, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 12, 2016

First Posted

December 16, 2016

Study Start

November 1, 2016

Primary Completion

August 1, 2019

Study Completion

September 1, 2019

Last Updated

March 28, 2019

Record last verified: 2019-03

Locations