The objective of this study was to evaluate the effect of laparoscopic surgical treatment on clinical pregnancy in infertile women with minimal or mild endometriosis. This clinical trial study was performed in 146 infertile women (20-35 years old) who were referred to the gynecological clinic between April 2008 and March 2009. After considering inclusion and exclusion criteria and confirmation of minimal or mild endometriosis by diagnostic laparoscopy in all patients, they were randomly assigned into two groups using consecutively numbered, opaque sealed envelopes. Diagnostic laparoscopy (no treatment) was performed for the first group but the second group underwent operative laparoscopy as well. The primary outcome of the present study was normal intrauterine pregnancy occurrence during 9 months of follow-up. If β-HCG was positive sonography would be performed for confirmation of normal intrauterine pregnancy. Secondary outcome was complications during or after operation such as: intestinal injury, slight tear of the tubal serosa, vascular trauma, infection of wounds and hematomas and finally urinary tract infection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012311952N2
Registration date:2011-12-08, 1390/09/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-12-08, 1390/09/17
Registrant information
Name
Ashraf Moini
Name of organization / entity
Tehran University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 3283
Email address
hosp_arash@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2008-01-01, 1386/10/11
Expected recruitment end date
2010-01-01, 1388/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Fertility outcome after operative laparoscopy versus no treatment in infertile women with minimal or mild endometriosis
Public title
Comparison of laparoscopic surgery with no treatment in infertile women with endometriosis
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: age between 20—35 years old, unexplained infertility more than 1 year, normal semen analysis, normal ovulatory cycles (menstrual interval 24-35 days and biphasic basal temperature), normal hormonal assay (TSH, FSH, PRL) and normal hystrosalpingography.
Exclusion criteria: surgical history for infertility or endometriosis, oophorectomy, salpingectomy, history of PID (Pelvic Inflammation Disease) and women who received any treatment for endometriosis during the previous 3 months.
Age
From 20 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Mecial Sciences
City
Tehran
Postal code
Approval date
2011-11-28, 1390/09/07
Ethics committee reference number
90/د/130/1587
Health conditions studied
1
Description of health condition studied
Pregnancy, childbirth and the puerperium
ICD-10 code
028-9
ICD-10 code description
Abnormal finding on antenatal screening of mother, unspecified
Primary outcomes
1
Description
normal intrauterine pregnancy occurrence
Timepoint
Every 8 weeks during 9 months follow-up.
Method of measurement
β-HCG test; and If β-HCG was positive, sonography will be performed for confirmation of normal intrauterine pregnancy. (Clinical pregnancy was defined by the visualization of an embryo with cardiac activity at 6-7 weeks of pregnancy)
Secondary outcomes
1
Description
complications during or post operation such as: intestinal contusion, slight tear of the tubal serosa, vascular trauma, infection of wounds and hematomas and finally urinary tract infection.
Timepoint
during or post operation
Method of measurement
Clinical examination and observation
Intervention groups
1
Description
Control group: diagnostic laparoscopy (no treatment after diagnosis)
Category
Treatment - Surgery
2
Description
Intervention group: diagnostic laparoscopy as well as appropriate operative laparoscopy
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dr Akbar Fotouhi
Full name of responsible person
Vice chansellor for research
Street address
Unit 601, Sixth floor, Keshavrz Blvd., Ghods Ave., Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?