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

Study Overview
=================
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.

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

Conditions
-----------------
Ectopic Pregnancy, Infertility

Intervention / Treatment
-----------------
* Drug: Methotrexate
* Procedure: salpingectomy


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Methotrexate only<br>Single dose of systemic Methotrexate administered to 55 patients. | Drug: Methotrexate<br>* single dose systemic methotrexate administration (50 mg/m2)<br>* Other names: Mtx;|
| Active Comparator: Salpingectomy only group<br>Laparoscopic unilateral salpingectomy performed to 61 patients. | Procedure: salpingectomy<br>* Laparoscopic unilateral salpingectomy<br>|
| Active Comparator: Salpingectomy following Methotrexate<br>15 patients underwent laparoscopic unilateral salpingectomy following unsuccessful single dose of methotrexate administration. | Drug: Methotrexate<br>* single dose systemic methotrexate administration (50 mg/m2)<br>* Other names: Mtx;Procedure: salpingectomy<br>* Laparoscopic unilateral salpingectomy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovarian reserve assessment by measuring AMH level. | Ovarian reserve were assessed before and after treatment by measuring AMH levels. | 1-3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years of follow up after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ectopic pregnancy, ovarian reserve, salpingectomy, methotrexate