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

Recruiting

• Conditions: Ectopic Pregnancy
• Interventions: Diagnostic Test: Amh hormone

• Registration Number: NCT06471166
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-18
• Study First Submitted QC: 2024-06-18
• Last Update Submitted: 2024-06-18
• Study First Posted: 2024-06-24
• Last Update Posted: 2024-06-24
• Study Start: 2024-07-10
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Conservative management	Amh hormone	-
Surgical treatment (Open or laparoscopic salpingectomy)	Amh hormone	-
Conservative surgical treatment (salpingotomy, salpingostomy, tubal milking)	Amh hormone	-
Medical treatment	Amh hormone	-
Conservative surgical treatment after failed medical treatment	Amh hormone	-
Surgical treatment after failed medical treatment (Open or laparoscopic salpingectomy)	Amh hormone	-

Primary Outcome Measures

Name	Time	Method
Change in levels of AMH pre and post treatment	3 months

Trial Locations

Locations (1)

Assiut university; 🇪🇬 Assiut, Egypt