This is study is a quasi-experimental study which will not be randomized. A total of 126 patients with tubal ectopic pregnancy who will refer to Arash hospital between the ages of 18 and 40 and will be in need of laparoscopic surgery will be involved in this study.The purpose of this study is to determine the effects of laparoscopic salpingectomy on ovarian reserve in comparison to laparoscopic salpingostomy. All Patients who wants to use oral contraceptives and smoker women and patients with previous infertility or prior pelvic pathology will be excluded. Ovarian reserve is evaluated by serum AMH level before and three months after surgerOvarian reserve is evaluated by measurement of AMH level before and three months after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016051627930N1
Registration date:2016-10-31, 1395/08/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-10-31, 1395/08/10
Registrant information
Name
Fatemeh Tabatabaei
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3325 1646
Email address
f-tabatabie@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center of Tehran medical science of university
Expected recruitment start date
2016-11-10, 1395/08/20
Expected recruitment end date
2017-07-31, 1396/05/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of laparoscopic salpingectomy effect on ovarian reserve versus laparoscopic salpingostomy.
Public title
Comparison of ovarian reserve in laparoscopic surgery with and without tubal preservation.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients with tubal ectopic pregnancy who are in need of laparoscopic surgery and come to Arash hospital; aged between 18-40 years old
Exclusion criteria: smokers; patients with gynecologic disorders that affect ovarian function such as endometriosis, previous ovarian or tubal surgeries; history of infertility treatment; and patients who wanted to use oral contraceptives after surgery
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Science, Qods Street, Keshavarz Boulevard
City
Tehran
Postal code
Approval date
2016-10-02, 1395/07/11
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1395.706
Health conditions studied
1
Description of health condition studied
Tubal ectopic pregnancy
ICD-10 code
O00.1
ICD-10 code description
Tubal pregnancy
Primary outcomes
1
Description
ovarian reserve
Timepoint
before and three months after surgery
Method of measurement
blood sampling
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:In this group we measure AMH level before and three months after laparoscopic salpingectomy.
Category
Treatment - Surgery
2
Description
control group:In this group we measure AMH level before and three months after laparoscopic salpingosctomy.