Trial record 5 of 32 for:    salpingectomy

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Enes Taylan, Ege University
ClinicalTrials.gov Identifier:
NCT02714998
First received: March 14, 2016
Last updated: March 16, 2016
Last verified: March 2016
  Purpose
The investigators aimed to investigate the effects of salpingectomy and Methotrexate administration on ovarian reserve in ectopic pregnancy.

Condition Intervention
Ectopic Pregnancy
Infertility
Drug: Methotrexate
Procedure: salpingectomy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of Salpingectomy and Single Dose Systemic Methotrexate Treatments on Ovarian Reserve in Ectopic Pregnancy

Resource links provided by NLM:


Further study details as provided by Ege University:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 131
Study Start Date: January 2013
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02714998

Locations
Turkey
Ege University School of Medicine Department of Obstetrics and Gynecology
Izmir, Turkey, 35100
Sponsors and Collaborators
Ege University
Investigators
Study Director: Ahmet M. Ergenoglu, Ass. Prof. Ege University School of Medicine Department of Obstetrics and Gynecology
  More Information

Responsible Party: Enes Taylan, Medical Doctor, Ob&Gyn Specialist, Ege University
ClinicalTrials.gov Identifier: NCT02714998     History of Changes
Other Study ID Numbers: 2013-TIP-043 
Study First Received: March 14, 2016
Last Updated: March 16, 2016
Individual Participant Data  
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 Ege University:
ectopic pregnancy
ovarian reserve
salpingectomy
methotrexate

Additional relevant MeSH terms:
Infertility
Pregnancy, Ectopic
Cardiac Complexes, Premature
Genital Diseases, Male
Genital Diseases, Female
Pregnancy Complications
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
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

ClinicalTrials.gov processed this record on January 19, 2017