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
2017-03-31, 1396/01/11
2019-03-31, 1398/01/11
20172019-03-31 00:00:00
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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.
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.
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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.
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.
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
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 39 Normal semen analysis in their spouse Previous failed IVF procedures at least for 2 times No laparoscopic contraindications
نان 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
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
نانزنان 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
Aged more than 39 year
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
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
سن بالای 39 سال
سن بالای 39 سال
جراحی قبلی تخمدان
بیماری های غدد درون ریز از جمله دیابت، تومورهای وابسته به استروژن، بیماری تیروئید، سندرم کوشینگ، یا هیپرپلازی مادرزادی آدرنال
سن بالای 39 سال جراحی قبلی تخمدان بیماری های غدد درون ریز از جمله دیابت، تومورهای وابسته به استروژن، بیماری تیروئید، سندرم کوشینگ، یا هیپرپلازی مادرزادی آدرنال
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
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.
The Block randomization method is appliedon the basis of a block randomization list which is designed by thean epidemiologist colleague using STATAthe Stata software (LLC StataCorp, USA) version 13) and a block size of 6. The type ofrandom allocation process is concealed by providing 34 consecutive treatment cards that is placed in the envelope based on the randomization list and thesealed 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 envelope,project methodologist has known that this code is related to which the epidemiologist knows abouttreatment group. When the doctor confirmedannounces that a patient is eligible, the eligibilitymethodologist 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 patient to entertype of treatment performed. The data analysis is performed by a statistician who is unaware of all the study, a midwife gives the pocket to the doctor‘s processes.
روش تصادفی بلوک توسط اپیدمیولوژیست با استفاده از نسخه STATA13 طراحی شده است. نوع درمان بر اساس لیست رندومیزیشن در پاکت قرار داده می شود . وقتی پزشک صلاحیت بیمار را تأیید کرد ، ماما که از مطالعه خارج است پاکت را به دکتر می دهد
روش تصادفی سازی بر اساس یک لیست تصادفی بلوکی است که توسط یک همکار اپیدمیولوژیست با استفاده از نرم افزار Stata (LLC StataCorp، ایالات متحده آمریکا) نسخه 13 و اندازه بلوک 6 طراحی شده است. فرآیند تخصیص تصادفی با ارائه 34 کارت درمانی متوالی پنهان شده است. که در پاکت های مهر و موم شده قرار می گیرد. روی هر پاکت یک کد 10 رقمی تصادفی بدون ترتیب و قاب نوشته شده است. این کد مربوطه شماره شناسایی بیمار است و فقط متدولوژیست پروژه می داند که این کد مربوط به کدام گروه درمانی است. زمانی که پزشک واجد شرایط بودن بیمار را اعلام می کند، متدولوژیست طرح پاکت را در اختیار پزشک قرار می دهد و درمان مورد نظر بر اساس نوع ذکر شده در پاکت انتخاب می شود. فرد ارزیابی کننده نتایج نیز شخص ثالثی است که از نوع درمان انجام شده بی اطلاع است. تجزیه و تحلیل داده ها توسط متخصص آماری انجام می شود که از تمام فرآیندهای مطالعه بی اطلاع است.
روش تصادفی بلوکسازی بر اساس یک لیست تصادفی بلوکی است که توسط یک همکار اپیدمیولوژیست با استفاده از نرم افزار Stata (LLC StataCorp، ایالات متحده آمریکا) نسخه STATA1313 و اندازه بلوک 6 طراحی شده است. نوعفرآیند تخصیص تصادفی با ارائه 34 کارت درمانی متوالی پنهان شده است. که در پاکت های مهر و موم شده قرار می گیرد. روی هر پاکت یک کد 10 رقمی تصادفی بدون ترتیب و قاب نوشته شده است. این کد مربوطه شماره شناسایی بیمار است و فقط متدولوژیست پروژه می داند که این کد مربوط به کدام گروه درمانی است. زمانی که پزشک واجد شرایط بودن بیمار را اعلام می کند، متدولوژیست طرح پاکت را در اختیار پزشک قرار می دهد و درمان مورد نظر بر اساس لیست رندومیزیشننوع ذکر شده در پاکت قرارانتخاب می شود. فرد ارزیابی کننده نتایج نیز شخص ثالثی است که از نوع درمان انجام شده بی اطلاع است. تجزیه و تحلیل داده ها توسط متخصص آماری انجام می شود . وقتی پزشک صلاحیت بیمار را تأیید کرد ، ماما که از تمام فرآیندهای مطالعه خارجبی اطلاع است پاکت را به دکتر می دهد.
Secondary outcomes
#1
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Live birth rate
Live birth rate
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میزان تولد زنده
میزان تولد زنده
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The delivery of a fetus who shows evidence of life after that is entirely outside of the mother
The delivery of a fetus who shows evidence of life after that is entirely outside of the mother
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زایمان جنینی که پس از خروج کامل از بدن مادر شواهدی از زندگی نشان می دهد
زایمان جنینی که پس از خروج کامل از بدن مادر شواهدی از زندگی نشان می دهد
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Through hospital reports and telephone follow-up of patients
Through hospital reports and telephone follow-up of patients
empty
از طریق بررسی گزارش بیمارستان و پیگیری تلفنی از بیماران
از طریق بررسی گزارش بیمارستان و پیگیری تلفنی از بیماران
#2
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The pregnancy complications
The pregnancy complications
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عوارض دوران بارداری
عوارض دوران بارداری
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during 9 months of pregnancy
during 9 months of pregnancy
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در طی 9 ماه بارداری
در طی 9 ماه بارداری
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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.
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.
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عوارضی مانند زایمان زودرس یا پارگی زودرس کیسه آب پیش از ۳۷ هغته بارداری و تشخیص فشار خون بالای ۱۴۰ بر ۹۰ به همراه ادم و دفع پروتئین در ادرار (پره اکلامپسی) و همچنین تشخیص دیابت بارداری (گلوکز ناشتای پلاسما مساوی و یا بیشتر از 92 میلی گرم در دسی لیتر به همراه گلوکز 1 ساعت پس از مصرف ۷۵ گرم گلوکز مساوی یا بیشتر از 180میلی گرم در دسی لیتر) از طریق گزارش بیمارستان و پیگیری تلفنی بررسی می گردد.
عوارضی مانند زایمان زودرس یا پارگی زودرس کیسه آب پیش از ۳۷ هغته بارداری و تشخیص فشار خون بالای ۱۴۰ بر ۹۰ به همراه ادم و دفع پروتئین در ادرار (پره اکلامپسی) و همچنین تشخیص دیابت بارداری (گلوکز ناشتای پلاسما مساوی و یا بیشتر از 92 میلی گرم در دسی لیتر به همراه گلوکز 1 ساعت پس از مصرف ۷۵ گرم گلوکز مساوی یا بیشتر از 180میلی گرم در دسی لیتر) از طریق گزارش بیمارستان و پیگیری تلفنی بررسی می گردد.
#3
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Ovarian hyperstimulation syndrome rate
Ovarian hyperstimulation syndrome rate
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میزان سندرم تحریک بیش از حد تخمدانی
میزان سندرم تحریک بیش از حد تخمدانی
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3 and 10 days after ovarian puncture
3 and 10 days after ovarian puncture
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3 و 10 روز پس از تخمک گیری
3 و 10 روز پس از تخمک گیری
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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
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
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بررسی علائم، نشانه های تحریک بیش از حد تخمدان (درد خفیف تا متوسط در شکم نفخ شکم یا افزایش اندازه دور کمر، حالت تهوع و استفراغ، اسهال، حساسیت در ناحیه تخمدان ها) و سونوگرافی واژینال
بررسی علائم، نشانه های تحریک بیش از حد تخمدان (درد خفیف تا متوسط در شکم نفخ شکم یا افزایش اندازه دور کمر، حالت تهوع و استفراغ، اسهال، حساسیت در ناحیه تخمدان ها) و سونوگرافی واژینال
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr akbare Fotohi
Full name of responsible person - Persian: دکتر اکبر فتوحی
Street address - English: Qods St, Keshavarz Blvd
Street address - Persian: بولوار کشاورز. خیابان قدس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1417653761
Phone: +98 21 8163 3698
Fax:
Email: vcr@tums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr Akbar Fotouhi
Full name of responsible person - Persian: دکتر اکبر فتوحی
Street address - English: Qods St, Keshavarz Blvd
Street address - Persian: بولوار کشاورز. خیابان قدس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1417653761
Phone: +98 21 8163 3698
Fax:
Email: vcr@tums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr akbare FotohiAkbar Fotouhi Full name of responsible person - Persian: دکتر اکبر فتوحی Street address - English: Qods St, Keshavarz Blvd Street address - Persian: بولوار کشاورز. خیابان قدس City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1417653761 Phone: +98 21 8163 3698 Fax: Email: vcr@tums.ac.ir Web page address:
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
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.
Acronym
IRCT registration information
IRCT registration number:IRCT20090526001952N14
Registration date:2021-02-17, 1399/11/29
Registration timing:retrospective
Last update:2022-11-16, 1401/08/25
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
2019-03-31, 1398/01/11
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
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
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
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.