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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02714998
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : March 22, 2016
Sponsor:
Information provided by (Responsible Party):
Enes Taylan, Ege University

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

Condition or disease Intervention/treatment Phase
Ectopic Pregnancy Infertility Drug: Methotrexate Procedure: salpingectomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Salpingectomy and Single Dose Systemic Methotrexate Treatments on Ovarian Reserve in Ectopic Pregnancy
Study Start Date : January 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Methotrexate only
Single dose of systemic Methotrexate administered to 55 patients.
Drug: Methotrexate
single dose systemic methotrexate administration (50 mg/m2)
Other Name: Mtx

Active Comparator: Salpingectomy only group
Laparoscopic unilateral salpingectomy performed to 61 patients.
Procedure: salpingectomy
Laparoscopic unilateral salpingectomy

Active Comparator: Salpingectomy following Methotrexate
15 patients underwent laparoscopic unilateral salpingectomy following unsuccessful single dose of methotrexate administration.
Drug: Methotrexate
single dose systemic methotrexate administration (50 mg/m2)
Other Name: Mtx

Procedure: salpingectomy
Laparoscopic unilateral salpingectomy




Primary Outcome Measures :
  1. Ovarian reserve assessment by measuring AMH level. [ Time Frame: 1-3 months ]
    Ovarian reserve were assessed before and after treatment by measuring AMH levels.


Secondary Outcome Measures :
  1. Number of participants with treatment related adverse effect on fertility. [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714998


Locations
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Turkey
Ege University School of Medicine Department of Obstetrics and Gynecology
Izmir, Turkey, 35100
Sponsors and Collaborators
Ege University
Investigators
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Study Director: Ahmet M. Ergenoglu, Ass. Prof. Ege University School of Medicine Department of Obstetrics and Gynecology
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Responsible Party: Enes Taylan, Medical Doctor, Ob&Gyn Specialist, Ege University
ClinicalTrials.gov Identifier: NCT02714998    
Other Study ID Numbers: 2013-TIP-043
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The investigators have not decided to share patient data yet. However, it is possible if approved by ethical committee.
Keywords provided by Enes Taylan, Ege University:
ectopic pregnancy
ovarian reserve
salpingectomy
methotrexate
Additional relevant MeSH terms:
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Infertility
Pregnancy, Ectopic
Cardiac Complexes, Premature
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Pregnancy Complications
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors