NCT02714998

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 22, 2016

Completed
Last Updated

March 22, 2016

Status Verified

March 1, 2016

Enrollment Period

2.1 years

First QC Date

March 14, 2016

Last Update Submit

March 16, 2016

Conditions

Ectopic PregnancyInfertility

Keywords

ectopic pregnancyovarian reservesalpingectomymethotrexate

Outcome Measures

Primary Outcomes (1)

  • Ovarian reserve assessment by measuring AMH level.

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

    1-3 months

Secondary Outcomes (1)

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

    2 years of follow up after treatment

Study Arms (3)

Methotrexate only

ACTIVE COMPARATOR

Single dose of systemic Methotrexate administered to 55 patients.

Drug: Methotrexate

Salpingectomy only group

ACTIVE COMPARATOR

Laparoscopic unilateral salpingectomy performed to 61 patients.

Procedure: salpingectomy

Salpingectomy following Methotrexate

ACTIVE COMPARATOR

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

Drug: MethotrexateProcedure: salpingectomy

Interventions

MethotrexateDRUG

single dose systemic methotrexate administration (50 mg/m2)

Also known as: Mtx
Methotrexate onlySalpingectomy following Methotrexate
salpingectomyPROCEDURE

Laparoscopic unilateral salpingectomy

Salpingectomy following MethotrexateSalpingectomy only group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ectopic pregnancy diagnosis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University School of Medicine Department of Obstetrics and Gynecology

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pregnancy, EctopicInfertility

Interventions

MethotrexateSalpingectomy

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ahmet M. Ergenoglu, Ass. Prof.

    Ege University School of Medicine Department of Obstetrics and Gynecology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, Ob&Gyn Specialist

Study Record Dates

First Submitted

March 14, 2016

First Posted

March 22, 2016

Study Start

January 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 22, 2016

Record last verified: 2016-03

Locations

TU(1)