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CompletedNCT02714998Updated Mar 22, 2016

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

An interventional study of Methotrexate and salpingectomy in Ectopic Pregnancy and Infertility, sponsored by Ege University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2016-03-22.

Sponsored by Ege University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
131
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Ectopic Pregnancy
  • Infertility

Keywords

  • ectopic pregnancy
  • ovarian reserve
  • salpingectomy
  • methotrexate
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 131 is close to the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Ege University is the lead sponsor of 365 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • ectopic pregnancy diagnosis

Exclusion criteria

Exclusion Criteria:

  • history of endometriosis, ovarian surgery, systemic chemotherapy, ART treatment.
  • patients treated with multiple doses of methotrexate or different surgical procedure (salpingostomy, milking)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
131 participants (actual)

Study arms

  • Active comparator
    Methotrexate only

    Single dose of systemic Methotrexate administered to 55 patients.

    Drug: Methotrexate

  • Active comparator
    Salpingectomy only group

    Laparoscopic unilateral salpingectomy performed to 61 patients.

    Procedure: salpingectomy

  • Active comparator
    Salpingectomy following Methotrexate

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

    Drug: Methotrexate · Procedure: salpingectomy

Interventions

  • DrugMethotrexate

    single dose systemic methotrexate administration (50 mg/m2)

    Also known as: Mtx

  • Proceduresalpingectomy

    Laparoscopic unilateral salpingectomy

06

What researchers measure

Primary outcomes

  1. Ovarian reserve assessment by measuring AMH level.

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

    Time frame: 1-3 months

Secondary outcomes

  1. 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.

    Time frame: 2 years of follow up after treatment

07

Study locations

1 site
  • Ege University School of Medicine Department of Obstetrics and Gynecology
    Izmir, 35100, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided — The investigators have not decided to share patient data yet. However, it is possible if approved by ethical committee.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02714998
Lead sponsor
Ege University
Responsible party
Enes Taylan (Medical Doctor, Ob&Gyn Specialist, Ege University) — Principal investigator
First posted
Mar 22, 2016
Start date
Jan 2013
Primary completion
Feb 2015
Completion
Feb 2015
Last update
Mar 22, 2016

Study contacts

Ahmet M. Ergenoglu, Ass. Prof.
study director · Ege University School of Medicine Department of Obstetrics and Gynecology

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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