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

NCT ID: NCT02714998

Last Updated: 2016-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Ectopic Pregnancy Infertility

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Methotrexate only

Single dose of systemic Methotrexate administered to 55 patients.

Group Type ACTIVE_COMPARATOR

Methotrexate

Intervention Type DRUG

single dose systemic methotrexate administration (50 mg/m2)

Salpingectomy only group

Laparoscopic unilateral salpingectomy performed to 61 patients.

Group Type ACTIVE_COMPARATOR

salpingectomy

Intervention Type PROCEDURE

Laparoscopic unilateral salpingectomy

Salpingectomy following Methotrexate

15 patients underwent laparoscopic unilateral salpingectomy following unsuccessful single dose of methotrexate administration.

Group Type ACTIVE_COMPARATOR

Methotrexate

Intervention Type DRUG

single dose systemic methotrexate administration (50 mg/m2)

salpingectomy

Intervention Type PROCEDURE

Laparoscopic unilateral salpingectomy

Interventions

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Methotrexate

single dose systemic methotrexate administration (50 mg/m2)

Intervention Type DRUG

salpingectomy

Laparoscopic unilateral salpingectomy

Intervention Type PROCEDURE

Other Intervention Names

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Mtx

Eligibility Criteria

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Inclusion Criteria

* ectopic pregnancy diagnosis

Exclusion Criteria

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

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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Enes Taylan

Medical Doctor, Ob&Gyn Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmet M. Ergenoglu, Ass. Prof.

Role: STUDY_DIRECTOR

Ege University School of Medicine Department of Obstetrics and Gynecology

Locations

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Ege University School of Medicine Department of Obstetrics and Gynecology

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2013-TIP-043

Identifier Type: -

Identifier Source: org_study_id

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