The Effect of Different Treatment Modalities of Tubal Ectopic Pregnancy on Ovarian Reserve: a Prospective Cohort Study

June 18, 2024 updated by: Andro Bahgat Heshmat, Assiut University
Detect the effect of different treatment modalities of tubal ectopic pregnancy on ovarian reserve

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

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 Contact

Study Locations

  • Egypt
      • Assiut, Egypt
        • Recruiting
        • Assiut University
        • Contact:
          • Andro Bahgat, Md

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

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Women's Health Hospital, Department of Obstetrics and Gynecology, Faculty of Medicine, Assiut University

Description

Inclusion Criteria:

  • The study will include patients aged 18-44 years with known diagnosis or suspicion of diagnosis of tubal ectopic pregnancy (abnormal doubling rates of their b-HCG levels as well as ultrasonographically identified or unidentified gestational sacs outside the uterus)
  • Included patients must have capacity to provide informed consent. Given the potential emergent nature of presentation, women will not be recruited if fully informed consent could be compromised due to a highly distressed emotional state or significant hemorrhage necessitating the need for urgent surgery

Exclusion Criteria:

  1. The use of hormonal contraceptives within two months of enrolment
  2. If other surgery was conducted at the time of salpingectomy.
  3. If a woman was pregnant at follow up visit for AMH measurement
  4. History of previous surgeries of fallopian tubes and/or ovaries

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Conservative management
Diagnostic test: Amh hormone
Ovarian reserve
Medical treatment
Diagnostic test: Amh hormone
Ovarian reserve
Surgical treatment (Open or laparoscopic salpingectomy)
Diagnostic test: Amh hormone
Ovarian reserve
Surgical treatment after failed medical treatment (Open or laparoscopic salpingectomy)
Diagnostic test: Amh hormone
Ovarian reserve
Conservative surgical treatment (salpingotomy, salpingostomy, tubal milking)
Diagnostic test: Amh hormone
Ovarian reserve
Conservative surgical treatment after failed medical treatment
Diagnostic test: Amh hormone
Ovarian reserve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in levels of AMH pre and post treatment
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

Assiut University

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 (Estimated)

July 10, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 10, 2025

Study Registration Dates

First Submitted

June 18, 2024

First Submitted That Met QC Criteria

June 18, 2024

First Posted (Actual)

June 24, 2024

Study Record Updates

Last Update Posted (Actual)

June 24, 2024

Last Update Submitted That Met QC Criteria

June 18, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ectopic pregnancy

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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