Assessment of infertility treatment success by laparoscopic ovarian cautery in patients with poly cystic ovary syndrome and Previous failed IVF procedures referred to infertility clinic of Arash women hospital: a clinical trial
Assessment of infertility treatment success by laparoscopic ovarian cautery in patients with poly cystic ovary syndrome and Previous failed IVF procedures referred to infertility clinic of Arash women hospital: a clinical trial
Design
a randomized clinical trial with a parallel-group design of 34 patients. We will use the block randomization method by using: www.sealedenvelope.com
Settings and conduct
This clinical trial is conducted to evaluate 34 infertile eligible patients with PCOS who refer to Arash Women's Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with poly cystic ovary syndrome who have two of the three diagnostic criteria Rotterdam at least, age between 18- 35 year- old, body mass index less than 39, infertility for over a year, normal semen analysis in their spouse, previous failed IVF procedures at least for 2 times.
ٍExclusion criteria: Aged more than 39 year- old
Intervention groups
]n the intervention group, laparoscopic ovarian catheter surgery is performed for patients using 40-watt bipolar current at 4-6 points of the ovary and a month later, IVF / ET cycle treatment is performed. In the control group, patients enter the IVF / ET cycle without laparoscopic ovarian catheterization.
Main outcome variables
The oocyte and embryo quality, pregnancy loss, clinical pregnancy rate, pregnancy complications (gestational diabetes, preterm delivery, hypertension, and preeclampsia ) OHSS
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090526001952N14
Registration date:2021-02-17, 1399/11/29
Registration timing:retrospective
Last update:2021-02-17, 1399/11/29
Update count:2
Registration date
2021-02-17, 1399/11/29
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
2016-12-04, 1395/09/14
Expected recruitment end date
2017-03-31, 1396/01/11
Actual recruitment start date
2015-08-22, 1394/05/31
Actual recruitment end date
2017-03-31, 1396/01/11
Trial completion date
2017-03-31, 1396/01/11
Scientific title
Assessment of infertility treatment success by laparoscopic ovarian cautery in patients with poly cystic ovary syndrome and Previous failed IVF procedures referred to infertility clinic of Arash women hospital: a clinical trial
Public title
Assessment of pregnancy rate by laparoscopic ovarian cautery in patients with poly cystic ovary syndrome and Previous failed IVF procedures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with poly cystic ovary syndrome who have two of the three diagnostic criteria Rotterdam at least
Age between 18- 35 year- old
Body mass index less than 39
Normal semen analysis in their spouse
Previous failed IVF procedures at least for 2 times
Exclusion criteria:
Aged more than 39 year
Age
From 18 years old to 39 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
34
Actual sample size reached:
34
Randomization (investigator's opinion)
Randomized
Randomization description
The Block randomization method is applied by the epidemiologist using STATA software (version 13). The type of treatment is placed in the envelope based on the randomization list and the code is written on the envelope, which the epidemiologist knows about. When the doctor confirmed the eligibility of the patient to enter the study, a midwife gives the pocket to the doctor
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
Tehran University of Medical Sciences , Deputy of Research
Street address
Qods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2015-08-09, 1394/05/18
Ethics committee reference number
IR.TUMS.REC.1394.542
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
pregnancy
Timepoint
sonography in 6th week of pregnancy with beta test 14 days after transfer
Method of measurement
sonography and pregnancy test
Secondary outcomes
1
Description
ova quality
Timepoint
before fertilization
Method of measurement
microscope
2
Description
abortion
Timepoint
before 20th week of pregnancy
Method of measurement
sonography
3
Description
Embryo quality
Timepoint
before transfer
Method of measurement
comments of emberiologist
Intervention groups
1
Description
Intervention group: Laparoscopic ovarian drilling is performed using 40-watt bipolar current at 4-6 points of the ovaries for patients and a month later undergo in vitro fertilization (IVF) cycle with ovarian stimulation using an antagonist protocol.
Category
Treatment - Surgery
2
Description
Control group: In this group, patients without laparoscopic ovarian drilling are treated only for in-vitro fertilization (IVF) cycle with ovarian stimulation using antagonist protocol.