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
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General information
2019-03-31, 1398/01/11
2018-01-01, 1396/10/11
20192018-0301-3101 00:00:00
A number of exclusion criteria were missed during registration in the site, which were added. Also, due to the fact that the sampling period of the study took longer than we had estimated, and on the other hand, pregnant patients were followed up until live birth, the trial termination time was edited.
The trial completion was 9 months after the actual recruitment end date, which was corrected in the system.
A number of exclusion criteria were missed during registrationThe trial completion was 9 months after the actual recruitment end date, which was corrected in the site, which were addedsystem. Also, due to the fact that the sampling period of the study took longer than we had estimated, and on the other hand, pregnant patients were followed up until live birth, the trial termination time was edited.
تعدادی از معیارهای خروج از مطالعه در هنگام ثبت کارآزمایی بالینی در سایت از قلم افتاده بوده است که اضافه شد. همچنین به علت اینکه مدت نمونه گیری مطالعه نیز بیشتر از زمانی که تخمین زده بودیم طول کشیده است و از طرفی بیماران باردار تا زمان تولد زنده نیز پیگیری شدند زمان خاتمه کارآزمایی ادیت شد.
تاریخ پایان کارآزمایی 9 ماه پس از تمام شدن نمونه گیری بوده است که در سامانه اصلاح گردید.
تعدادیتاریخ پایان کارآزمایی 9 ماه پس از معیارهای خروج از مطالعه در هنگام ثبت کارآزمایی بالینی در سایت از قلم افتادهتمام شدن نمونه گیری بوده است که اضافه شددر سامانه اصلاح گردید. همچنین به علت اینکه مدت نمونه گیری مطالعه نیز بیشتر از زمانی که تخمین زده بودیم طول کشیده است و از طرفی بیماران باردار تا زمان تولد زنده نیز پیگیری شدند زمان خاتمه کارآزمایی ادیت شد.
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
No laparoscopic contraindications
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 30
Normal semen analysis in their spouse
Previous failed IVF procedures at least for 2 times
No laparoscopic contraindications
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 3930 Normal semen analysis in their spouse Previous failed IVF procedures at least for 2 times No laparoscopic contraindications
زنان مبتلا به سندروم تخمدان پلی کیستیک که حداقل 2 مورد از سه معیار تشخیص رتردام را داشته باشد
سن بین 18 تا 39 سال
شاخص توده بدنی کمتر از 39،
آنالیز نرمال سمن در همسران آنها
داشتن حداق 2 بار سابقه شکست روش کمک باروری
نداشتن کنتراندیکاسیون انجام لاپاروسکوپی
زنان مبتلا به سندروم تخمدان پلی کیستیک که حداقل 2 مورد از سه معیار تشخیص رتردام را داشته باشد
سن بین 18 تا 39 سال
شاخص توده بدنی کمتر از 30
آنالیز نرمال سمن در همسران آنها
داشتن حداق 2 بار سابقه شکست روش کمک باروری
نداشتن کنتراندیکاسیون انجام لاپاروسکوپی
زنان مبتلا به سندروم تخمدان پلی کیستیک که حداقل 2 مورد از سه معیار تشخیص رتردام را داشته باشد سن بین 18 تا 39 سال شاخص توده بدنی کمتر از 39،30 آنالیز نرمال سمن در همسران آنها داشتن حداق 2 بار سابقه شکست روش کمک باروری نداشتن کنتراندیکاسیون انجام لاپاروسکوپی
Primary outcomes
#1
pregnancy
Chemical pregnancy rate
Chemical pregnancy rate
حامله شدن
میزان بارداری شیمیایی
حامله شدنمیزان بارداری شیمیایی
sonography in 6th week of pregnancy with beta test 14 days after transfer
Beta-hCG test 14 days after embryo transfer
sonography in 6th week of pregnancy with betaBeta-hCG test 14 days after embryo transfer
سونوگرافی هفته 6 بارداری یا تست بتا در 14 روز بعد ازانتقال
انجام تست بارداری ( بتا - اچ سی جی) 14 روز بعد ازانتقال جنین
سونوگرافی هفته 6انجام تست بارداری یا تست( بتا در- اچ سی جی) 14 روز بعد ازانتقال جنین
sonography and pregnancy test
Laboratory kits for Beta-hCG assay
sonography and pregnancy testLaboratory kits for Beta-hCG assay
سونو گرافی و تست بارداری
کیتهای آزمایشگاهی مخصوص سنجش بتا
سونو گرافی و تست بارداریکیتهای آزمایشگاهی مخصوص سنجش بتا
#2
empty
Clinical pregnancy rate
Clinical pregnancy rate
empty
میزان حاملگی بالینی
میزان حاملگی بالینی
empty
6 to 7 weeks after embryo transfer
6 to 7 weeks after embryo transfer
empty
6 تا 7 هفته پس از انتقال جنین
6 تا 7 هفته پس از انتقال جنین
empty
Observing the gestational sac along with fetal heart activity in vaginal ultrasound
Observing the gestational sac along with fetal heart activity in vaginal ultrasound
empty
مشاهده ساک حاملگی به همراه فعالیت قلب جنین در سونوگرافی واژینال
مشاهده ساک حاملگی به همراه فعالیت قلب جنین در سونوگرافی واژینال
Secondary outcomes
#1
ova quality
oocyte quality
ovaoocyte quality
before fertilization
Ovum pick-up day
before fertilizationOvum pick-up day
قبل از لقاح
روز تخمک گیری
قبل از لقاحروز تخمک گیری
microscope
The number of Metaphase II oocytes obtained on the day of ovulation, which is reported by the embryologist
microscopeThe number of Metaphase II oocytes obtained on the day of ovulation, which is reported by the embryologist
میکروسکوپ
تعداد تخمکهای متافاز 2 بدست آمده در روز تخمک گیری که توسط جنین شناس گزارش می شود
میکروسکوپتعداد تخمکهای متافاز 2 بدست آمده در روز تخمک گیری که توسط جنین شناس گزارش می شود
#2
abortion
Abortion rate
abortionAbortion rate
سقط
میزان سقط
میزان سقط
#3
comments of emberiologist
It is determined by the embryologist based on the number of blastomeres and the percentage of fragmentation, multinucleation and symmetry on the third day after oocyte retrieval.
commentsIt is determined by the embryologist based on the number of emberiologistblastomeres and the percentage of fragmentation, multinucleation and symmetry on the third day after oocyte retrieval.
نظر امبریولوژیست
توسط امبریولوژیست بر اساس تعداد بلاستومرها و درصد قطعه قطعه شدن، چند هسته ای و تقارن در روز سوم پس از بازیابی تخمک تعیین می شود
نظرتوسط امبریولوژیست بر اساس تعداد بلاستومرها و درصد قطعه قطعه شدن، چند هسته ای و تقارن در روز سوم پس از بازیابی تخمک تعیین می شود
Protocol summary
Study aim
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
The trial completion was 9 months after the actual recruitment end date, which was corrected in the system.
Acronym
IRCT registration information
IRCT registration number:IRCT20090526001952N14
Registration date:2021-02-17, 1399/11/29
Registration timing:retrospective
Last update:2022-12-13, 1401/09/22
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
2018-01-01, 1396/10/11
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 30
Normal semen analysis in their spouse
Previous failed IVF procedures at least for 2 times
No laparoscopic contraindications
Exclusion criteria:
Aged more than 39 year
Previous ovarian surgery
Co-existing endocrine diseases including diabetes mellitus, estrogen-dependent tumors, thyroid disease, Cushing’s syndrome, or congenital adrenal hyperplasia
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 randomization method is on the basis of a block randomization list which is designed by an epidemiologist colleague using the Stata software (LLC StataCorp, USA) version 13 and a block size of 6. The random allocation process is concealed by providing 34 consecutive treatment cards that is placed in sealed envelopes. A random 10-digit code is written without sequence and frame on each envelope. This relevant code is patient’s identification number, and just the project methodologist has known that this code is related to which treatment group. When the doctor announces that a patient is eligible, the methodologist has provided the doctor with an envelope design and the desired treatment is selected based on the type mentioned in the envelope. The outcome’s evaluator also is considered of a third party person who is unaware of the type of treatment performed. The data analysis is performed by a statistician who is unaware of all the study‘s processes.
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
Chemical pregnancy rate
Timepoint
Beta-hCG test 14 days after embryo transfer
Method of measurement
Laboratory kits for Beta-hCG assay
2
Description
Clinical pregnancy rate
Timepoint
6 to 7 weeks after embryo transfer
Method of measurement
Observing the gestational sac along with fetal heart activity in vaginal ultrasound
Secondary outcomes
1
Description
oocyte quality
Timepoint
Ovum pick-up day
Method of measurement
The number of Metaphase II oocytes obtained on the day of ovulation, which is reported by the embryologist
2
Description
Abortion rate
Timepoint
before 20th week of pregnancy
Method of measurement
sonography
3
Description
Embryo quality
Timepoint
before transfer
Method of measurement
It is determined by the embryologist based on the number of blastomeres and the percentage of fragmentation, multinucleation and symmetry on the third day after oocyte retrieval.
4
Description
Live birth rate
Timepoint
The delivery of a fetus who shows evidence of life after that is entirely outside of the mother
Method of measurement
Through hospital reports and telephone follow-up of patients
5
Description
The pregnancy complications
Timepoint
during 9 months of pregnancy
Method of measurement
Complications such as premature delivery or premature rupture of the amniotic sac before 37 weeks of pregnancy and diagnosis of blood pressure above 140/90 (hypertension) along with edema and excretion of protein in the urine (Preeclampsia) as well as diagnosis of gestational diabetes (fasting plasma glucose equal to or greater than 92 mg/dL) with glucose 1 hour after consuming 75 grams of glucose equal to or more than 180 mg/dL) is recorded through checking the hospital report and telephone follow-up.
6
Description
Ovarian hyperstimulation syndrome rate
Timepoint
3 and 10 days after ovarian puncture
Method of measurement
Examination of symptoms, signs of ovarian hyperstimulation (mild to moderate pain in the abdomen, bloating or increased waist size, nausea and vomiting, diarrhea, tenderness in the ovaries) and vaginal ultrasound
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.