The Impact of Salpingectomy and Single Dose Systemic Methotrexate Treatments on Ovarian Reserve in Ectopic Pregnancy

Not Applicable

Completed

• Conditions: Ectopic Pregnancy; Infertility
• Interventions: Procedure: salpingectomy; Drug: Methotrexate

• Registration Number: NCT02714998
• Lead Sponsor: Ege University

Brief Summary

The investigators aimed to investigate the effects of salpingectomy and Methotrexate administration on ovarian reserve in ectopic pregnancy.

Detailed Description

In this study, the effects of unilateral laparoscopic salpingectomy and single dose of systemic Methotrexate administration on ovarian reserve in patients diagnosed with ectopic pregnancy were investigated.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2016-03
• Study First Submitted: 2016-03-14
• Study First Submitted QC: 2016-03-16
• Last Update Submitted: 2016-03-16
• Study First Posted: 2016-03-22
• Last Update Posted: 2016-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 131

Inclusion Criteria

• ectopic pregnancy diagnosis

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Exclusion Criteria

• history of endometriosis, ovarian surgery, systemic chemotherapy, ART treatment.
• patients treated with multiple doses of methotrexate or different surgical procedure (salpingostomy, milking)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Salpingectomy only group	salpingectomy	Laparoscopic unilateral salpingectomy performed to 61 patients.
Salpingectomy following Methotrexate	salpingectomy	15 patients underwent laparoscopic unilateral salpingectomy following unsuccessful single dose of methotrexate administration.
Methotrexate only	Methotrexate	Single dose of systemic Methotrexate administered to 55 patients.
Salpingectomy following Methotrexate	Methotrexate	15 patients underwent laparoscopic unilateral salpingectomy following unsuccessful single dose of methotrexate administration.

Primary Outcome Measures

Name	Time	Method
Ovarian reserve assessment by measuring AMH level.	1-3 months	Ovarian reserve were assessed before and after treatment by measuring AMH levels.

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment related adverse effect on fertility.	2 years of follow up after treatment	Rates of term delivery, spontaneous abortion, recurrent ectopic pregnancy and ongoing pregnancy for each group of patients were calculated during 2 years of follow up period.

Trial Locations

Locations (1)

Ege University School of Medicine Department of Obstetrics and Gynecology; 🇹🇷 Izmir, Turkey