Back to resultsThe 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
About this trial
This is an interventional treatment trial for Ectopic Pregnancy focused on measuring ectopic pregnancy, ovarian reserve, salpingectomy, methotrexate
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)
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
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
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