search
Back to results

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

Primary Purpose

Ectopic Pregnancy, Infertility

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Methotrexate
salpingectomy
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ectopic Pregnancy focused on measuring ectopic pregnancy, ovarian reserve, salpingectomy, methotrexate

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Ege University School of Medicine Department of Obstetrics and Gynecology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Methotrexate only

Salpingectomy only group

Salpingectomy following Methotrexate

Arm Description

Single dose of systemic Methotrexate administered to 55 patients.

Laparoscopic unilateral salpingectomy performed to 61 patients.

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

Outcomes

Primary Outcome Measures

Ovarian reserve assessment by measuring AMH level.
Ovarian reserve were assessed before and after treatment by measuring AMH levels.

Secondary Outcome Measures

Number of participants with treatment related adverse effect on fertility.
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.

Full Information

First Posted
March 14, 2016
Last Updated
March 16, 2016
Sponsor
Ege University
search

1. Study Identification

Unique Protocol Identification Number
NCT02714998
Brief Title
The Impact of Salpingectomy and Single Dose Systemic Methotrexate Treatments on Ovarian Reserve in Ectopic Pregnancy
Official Title
The Impact of Salpingectomy and Single Dose Systemic Methotrexate Treatments on Ovarian Reserve in Ectopic Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ectopic Pregnancy, Infertility
Keywords
ectopic pregnancy, ovarian reserve, salpingectomy, methotrexate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methotrexate only
Arm Type
Active Comparator
Arm Description
Single dose of systemic Methotrexate administered to 55 patients.
Arm Title
Salpingectomy only group
Arm Type
Active Comparator
Arm Description
Laparoscopic unilateral salpingectomy performed to 61 patients.
Arm Title
Salpingectomy following Methotrexate
Arm Type
Active Comparator
Arm Description
15 patients underwent laparoscopic unilateral salpingectomy following unsuccessful single dose of methotrexate administration.
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Other Intervention Name(s)
Mtx
Intervention Description
single dose systemic methotrexate administration (50 mg/m2)
Intervention Type
Procedure
Intervention Name(s)
salpingectomy
Intervention Description
Laparoscopic unilateral salpingectomy
Primary Outcome Measure Information:
Title
Ovarian reserve assessment by measuring AMH level.
Description
Ovarian reserve were assessed before and after treatment by measuring AMH levels.
Time Frame
1-3 months
Secondary Outcome Measure Information:
Title
Number of participants with treatment related adverse effect on fertility.
Description
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.
Time Frame
2 years of follow up after treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmet M. Ergenoglu, Ass. Prof.
Organizational Affiliation
Ege University School of Medicine Department of Obstetrics and Gynecology
Official's Role
Study Director
Facility Information:
Facility Name
Ege University School of Medicine Department of Obstetrics and Gynecology
City
Izmir
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The investigators have not decided to share patient data yet. However, it is possible if approved by ethical committee.

Learn more about this trial

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

We'll reach out to this number within 24 hrs