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

NCT06471166 | Recruiting

• 1 other identifier: Ectopic pregnancy
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Detect the effect of different treatment modalities of tubal ectopic pregnancy on ovarian reserve

Conditions

Ectopic Pregnancy

Outcome Measures

Primary Outcomes (1)

• Change in levels of AMH pre and post treatment

  3 months

Study Arms (6)

Conservative management

Diagnostic Test: Amh hormone

Medical treatment

Diagnostic Test: Amh hormone

Surgical treatment (Open or laparoscopic salpingectomy)

Diagnostic Test: Amh hormone

Surgical treatment after failed medical treatment (Open or laparoscopic salpingectomy)

Diagnostic Test: Amh hormone

Conservative surgical treatment (salpingotomy, salpingostomy, tubal milking)

Diagnostic Test: Amh hormone

Conservative surgical treatment after failed medical treatment

Diagnostic Test: Amh hormone

Interventions

Amh hormone DIAGNOSTIC_TEST

Ovarian reserve

Conservative management; Conservative surgical treatment (salpingotomy, salpingostomy, tubal milking); Conservative surgical treatment after failed medical treatment; Medical treatment; Surgical treatment (Open or laparoscopic salpingectomy); Surgical treatment after failed medical treatment (Open or laparoscopic salpingectomy)

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Pregnancy, Ectopic

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Andro Bahgat, MD

CONTACT

01283104773; androbahgat7@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 24, 2024
• Study Start: July 10, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 10, 2025
• Last Updated: June 24, 2024

Record last verified: 2024-06

Locations

EG (1)