Evaluation and comparison of Fixed versus Flexible Gonadotropin Releasing Hormone Antagonist Protocol in Controlled Ovarian Stimulation for In vitro Fertilization in Women with Polycystic Ovary Syndrome- A randomized clinical trial
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General information
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2023-09-06, 1402/06/15
2023-10-12, 1402/07/20
2023-0910-0612 00:00:00
2023-11-06, 1402/08/15
2024-02-29, 1402/12/10
20232024-1102-0629 00:00:00
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2023-10-12, 1402/07/20
2023-10-12 00:00:00
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2024-02-29, 1402/12/10
2024-02-29 00:00:00
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Update clinical trial based on the latest changes in the method and recruiment dates
Update clinical trial based on the latest changes in the method and recruiment dates
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به روز رسانی کارازمایی بالینی بر اساس اخرین تغییرات در روش کار وتاریخ بیمارگیری
به روز رسانی کارازمایی بالینی بر اساس اخرین تغییرات در روش کار وتاریخ بیمارگیری
Intervention groups
#1
Intervention group 1: (Fixed group) on the second day of the menstrual cycle, ultrasound will be performed and 150 IU rFSH gonadotropin will be injected daily . Then, starting from the fifth day of gonadotropin administration, 0.25 mg of sterotide will be administered daily until the trigger day. In both groups, with ultrasound monitoring when there are at least 2 follicles ≥17 mm in size, triggering with low dose HCG (1500-5000) and GnRH agonist or GnRH agonist alone will be done. 34-36 hours after the trigger, ovarian puncture will be performed under general anesthesia and ultrasound guidance. 72 hours after ovarian puncture, two embryos After three days of transfer, the rest of the embryos will be frozen. If there is a risk of Ovarian Hyperstimulation syndrome(OHSS) or serum progesterone level ≥ 2.25 ng/ml, all embryos will be frozen. OHSS in the form of follicle count ≥ 25 or serum estradiol level ≥4000, is defined.
Intervention group 1: (Fixed group) on the second day of the menstrual cycle, ultrasound will be performed and 150 IU rFSH gonadotropin will be injected daily . Then, starting from the fifth day of gonadotropin administration, 0.25 mg of sterotide will be administered daily until the trigger day. In both groups, with ultrasound monitoring when there are at least 2 follicles ≥17 mm in size, triggering with HCG (1500-5000 IU) and GnRH agonist or GnRH agonist alone will be done. 34-36 hours after the trigger, ovarian puncture will be performed under general anesthesia and ultrasound guidance. 72 hours after ovarian puncture, one or two cleavage stage embryos will be transfered, the rest of the embryos will be frozen. If there is a risk of Ovarian Hyperstimulation syndrome(OHSS) or serum progesterone level ≥ 2.25 ng/ml, all embryos will be frozen. OHSS in the form of follicle count ≥ 25 or serum estradiol level ≥4000, is defined.
Intervention group 1: (Fixed group) on the second day of the menstrual cycle, ultrasound will be performed and 150 IU rFSH gonadotropin will be injected daily . Then, starting from the fifth day of gonadotropin administration, 0.25 mg of sterotide will be administered daily until the trigger day. In both groups, with ultrasound monitoring when there are at least 2 follicles ≥17 mm in size, triggering with low dose HCG (1500-5000 IU) and GnRH agonist or GnRH agonist alone will be done. 34-36 hours after the trigger, ovarian puncture will be performed under general anesthesia and ultrasound guidance. 72 hours after ovarian puncture, one or two cleavage stage embryos After three days of transferwill be transfered, the rest of the embryos will be frozen. If there is a risk of Ovarian Hyperstimulation syndrome(OHSS) or serum progesterone level ≥ 2.25 ng/ml, all embryos will be frozen. OHSS in the form of follicle count ≥ 25 or serum estradiol level ≥4000, is defined.
گروه مداخله اول : ( گروه Fixed ) در روز دوم سیکل قاعدگی، سونوگرافی انجام و گنادوتروپین IU150 rFSH سینال-اف روزانه تزریق زیر جلدی شروع خواهد شد. سپس از پنجمین روز تجویز گنادوتروپین ،ستروتاید0.25 میلی گرم روزانه زیر جلدی تجویز شده وتا روز تریگر ادامه خواهد داشت.در هر دو گروه با مونیتورینگ سونوگرافی زمانی که حداقل 2 فولیکول ≥17میلمتری داشته باشد،جهت القای بلوغ نهایی اووسیت در همان روز دوز کم(HCG(1500-5000 به همراه آگونیست GnRHیا GnRH agonist به تنهایی تجویز خواهد شد. 34-36 ساعت پس از تریگر تحت بیهوشی عمومی وگاید سونوگرافی پونکسیون تخمدان انجام خواهد شد.72 ساعت پس از پونکسیون تخمدان، دو امبریو سه روزه ترانسفر وبقیه جنین ها فریز خواهند شد.در صورت وجود ریسک سندرم تحریک بیش از حد تخمدان (OHSS) یا سطح پروژسترون سرمی≥ 2.25 ng/ml تمامی جنین ها فریز خواهند شد. OHSS به صورت تعداد فولیکول ≥ 25 و یا میزان استرادیول سرمی≥4000 ، تعریف می شود.
گروه مداخله اول : ( گروه Fixed ) در روز دوم سیکل قاعدگی، سونوگرافی انجام و گنادوتروپین IU150 rFSH سینال-اف روزانه تزریق زیر جلدی شروع خواهد شد. سپس از پنجمین روز تجویز گنادوتروپین ،ستروتاید0.25 میلی گرم روزانه زیر جلدی تجویز شده وتا روز تریگر ادامه خواهد داشت.در هر دو گروه با مونیتورینگ سونوگرافی زمانی که حداقل 2 فولیکول ≥17میلمتری داشته باشد،جهت القای بلوغ نهایی اووسیت در همان روز (HCG(1500-5000 به همراه آگونیست GnRHیا GnRH agonist به تنهایی تجویز خواهد شد. 34-36 ساعت پس از تریگر تحت بیهوشی عمومی وگاید سونوگرافی پونکسیون تخمدان انجام خواهد شد.72 ساعت پس از پونکسیون تخمدان،یک تا دو امبریو سه روزه ترانسفر وبقیه جنین ها فریز خواهند شد.در صورت وجود ریسک سندرم تحریک بیش از حد تخمدان (OHSS) یا سطح پروژسترون سرمی≥ 2.25 ng/ml تمامی جنین ها فریز خواهند شد. OHSS به صورت تعداد فولیکول ≥ 25 و یا میزان استرادیول سرمی≥4000 ، تعریف می شود.
گروه مداخله اول : ( گروه Fixed ) در روز دوم سیکل قاعدگی، سونوگرافی انجام و گنادوتروپین IU150 rFSH سینال-اف روزانه تزریق زیر جلدی شروع خواهد شد. سپس از پنجمین روز تجویز گنادوتروپین ،ستروتاید0.25 میلی گرم روزانه زیر جلدی تجویز شده وتا روز تریگر ادامه خواهد داشت.در هر دو گروه با مونیتورینگ سونوگرافی زمانی که حداقل 2 فولیکول ≥17میلمتری داشته باشد،جهت القای بلوغ نهایی اووسیت در همان روز دوز کم(HCG(1500(HCG(1500-5000 به همراه آگونیست GnRHیا GnRH agonist به تنهایی تجویز خواهد شد. 34-36 ساعت پس از تریگر تحت بیهوشی عمومی وگاید سونوگرافی پونکسیون تخمدان انجام خواهد شد.72 ساعت پس از پونکسیون تخمدان،یک تا دو امبریو سه روزه ترانسفر وبقیه جنین ها فریز خواهند شد.در صورت وجود ریسک سندرم تحریک بیش از حد تخمدان (OHSS) یا سطح پروژسترون سرمی≥ 2.25 ng/ml تمامی جنین ها فریز خواهند شد. OHSS به صورت تعداد فولیکول ≥ 25 و یا میزان استرادیول سرمی≥4000 ، تعریف می شود.
#2
Intervention group 2: (Flexible group) From the second day of the menstrual cycle, daily subcutaneous gonadotropin IU150 rFSH was started, then if there was a dominant follicle 12-14 mm, Cetrotide 0.25 mg was prescribed and it will continue until the trigger day. In both groups, with ultrasound monitoring, when there are at least 2 follicles ≥17 mm, triggering with Low dose HCG (1500-5000) and GnRH agonist or GnRH agonist alone will be done . 34- 36 hours after the trigger, ovarian puncture will be performed under general anesthesia and ultrasound guidance. 72 hours after ovarian puncture, two three-day-old embryos will be transferred and the rest of the embryos will be frozen. If there is a risk of Ovarian Hyperstimulation Syndrome (OHSS) or serum progesterone level ≥ 2.25 ng/ml, all Embryos will be frozen.OHSS is defined as follicle count ≥25 or serum estradiol level ≥4000.
Intervention group 2: (Flexible group) From the second day of the menstrual cycle, daily subcutaneous gonadotropin IU150 rFSH was started, then if there was a dominant follicle 12-14 mm, Cetrotide 0.25 mg was prescribed and it will continue until the trigger day. In both groups, with ultrasound monitoring, when there are at least 2 follicles ≥17 mm, triggering with HCG (1500-5000 IU) and GnRH agonist or GnRH agonist alone will be done . 34- 36 hours after the trigger, ovarian puncture will be performed under general anesthesia and ultrasound guidance. 72 hours after ovarian puncture, one or two cleavage stage embryos will be transfered and the rest of the embryos will be frozen. If there is a risk of Ovarian Hyperstimulation Syndrome (OHSS) or serum progesterone level ≥ 2.25 ng/ml, all Embryos will be frozen.OHSS is defined as follicle count ≥25 or serum estradiol level ≥4000.
Intervention group 2: (Flexible group) From the second day of the menstrual cycle, daily subcutaneous gonadotropin IU150 rFSH was started, then if there was a dominant follicle 12-14 mm, Cetrotide 0.25 mg was prescribed and it will continue until the trigger day. In both groups, with ultrasound monitoring, when there are at least 2 follicles ≥17 mm, triggering with Low dose HCG (1500-5000 IU) and GnRH agonist or GnRH agonist alone will be done . 34- 36 hours after the trigger, ovarian puncture will be performed under general anesthesia and ultrasound guidance. 72 hours after ovarian puncture, one or two three-day-oldcleavage stage embryos will be transferredtransfered and the rest of the embryos will be frozen. If there is a risk of Ovarian Hyperstimulation Syndrome (OHSS) or serum progesterone level ≥ 2.25 ng/ml, all Embryos will be frozen.OHSS is defined as follicle count ≥25 or serum estradiol level ≥4000.
گروه مداخله دوم : ( گروه Flexible) از روز دوم سیکل قاعدگی، گنادوتروپین IU150 rFSH سینال -اف روزانه زیر جلدی شروع کرده سپس در صورت وجود فولیکول غالب 12- 14 میلی متری، Cetrotide 0.25 mg تجویز شد وتا روز تریگر ادامه خواهد داشت. در هر دو گروه با مونیتورینگ سونوگرافی زمانی که حداقل 2 فولیکول ≥17میلمتری داشته باشد،جهت القای بلوغ نهایی اووسیت در همان روز (Low dose HCG(1500-5000 به همراه GnRHاگونیست یا GnRH اگونیست به تنهایی تجویز خواهد شد. 34-36 ساعت پس از تریگر تحت بیهوشی عمومی وگاید سونوگرافی پونکسیون تخمدان انجام خواهد شد.72 ساعت پس از پونکسیون تخمدان، دو امبریو سه روزه ترانسفر وبقیه جنین ها فریز خواهند شد. در صورت وجود ریسک سندرم تحریک بیش از حد تخمدان (OHSS) یا سطح پروژسترون سرمی≥ 2.25 ng/ml تمامی جنین ها فریز خواهند شد. OHSS به صورت تعداد فولیکول ≥ 25 و یا میزان استرادیول سرمی≥4000 ، تعریف می شود.
گروه مداخله دوم : ( گروه Flexible) از روز دوم سیکل قاعدگی، گنادوتروپین IU150 rFSH سینال -اف روزانه زیر جلدی شروع کرده سپس در صورت وجود فولیکول غالب 12- 14 میلی متری، Cetrotide 0.25 mg تجویز شد وتا روز تریگر ادامه خواهد داشت. در هر دو گروه با مونیتورینگ سونوگرافی زمانی که حداقل 2 فولیکول ≥17میلمتری داشته باشد،جهت القای بلوغ نهایی اووسیت در همان روز (HCG(1500-5000 به همراه GnRHاگونیست یا GnRH اگونیست به تنهایی تجویز خواهد شد. 34-36 ساعت پس از تریگر تحت بیهوشی عمومی وگاید سونوگرافی پونکسیون تخمدان انجام خواهد شد.72 ساعت پس از پونکسیون تخمدان، یک یا دو امبریو سه روزه ترانسفر وبقیه جنین ها فریز خواهند شد. در صورت وجود ریسک سندرم تحریک بیش از حد تخمدان (OHSS) یا سطح پروژسترون سرمی≥ 2.25 ng/ml تمامی جنین ها فریز خواهند شد. OHSS به صورت تعداد فولیکول ≥ 25 و یا میزان استرادیول سرمی≥4000 ، تعریف می شود.
گروه مداخله دوم : ( گروه Flexible) از روز دوم سیکل قاعدگی، گنادوتروپین IU150 rFSH سینال -اف روزانه زیر جلدی شروع کرده سپس در صورت وجود فولیکول غالب 12- 14 میلی متری، Cetrotide 0.25 mg تجویز شد وتا روز تریگر ادامه خواهد داشت. در هر دو گروه با مونیتورینگ سونوگرافی زمانی که حداقل 2 فولیکول ≥17میلمتری داشته باشد،جهت القای بلوغ نهایی اووسیت در همان روز (Low dose HCG(1500-5000 به همراه GnRHاگونیست یا GnRH اگونیست به تنهایی تجویز خواهد شد. 34-36 ساعت پس از تریگر تحت بیهوشی عمومی وگاید سونوگرافی پونکسیون تخمدان انجام خواهد شد.72 ساعت پس از پونکسیون تخمدان، یک یا دو امبریو سه روزه ترانسفر وبقیه جنین ها فریز خواهند شد. در صورت وجود ریسک سندرم تحریک بیش از حد تخمدان (OHSS) یا سطح پروژسترون سرمی≥ 2.25 ng/ml تمامی جنین ها فریز خواهند شد. OHSS به صورت تعداد فولیکول ≥ 25 و یا میزان استرادیول سرمی≥4000 ، تعریف می شود.
Protocol summary
Study aim
Comparing the mean of Cetrotide injections, number of oocytes and embryos obtained with the A, B, C quality,gonadotropin dosage , duration of the ovarian stimulation period and frequency of OHSS (Ovarian Hyperstimulation Syndrome) in Flexible group with Fixed group.
Design
Phase 3 clinical trial with a control group will be conducted in parallel groups on 150 patients. Randomization of the samples will be done with a simple randomization method according to the generated list. The list of random numbers will be generated by a statistical consultant using Random Allocation1 software. 75 patients will be in the intervention group and 75 patients will be in the control group.
Settings and conduct
This clinical trial will be conducted in Yazd Infertility Research Center. The study and control cases will be selected among patients with Polycyctic ovary syndrome, referring to the infertility clinic ,candidates for Assisted reproductive technologies. People who meet the criteria for entering the study will be randomly placed in two groups of Fixed and Flexible.Blinding is not performed.
Participants/Inclusion and exclusion criteria
Women with polycystic ovary syndrome, candidate for ART(Assisted reproductive techniques) ,aged 20-40 with BMI in range of 20-30,without sever endometriosis and pelvic neoplasia and sever male factor infertility.
Intervention groups
Both groups will be selected from women with PCOS candidate for ART. On the 2th day of the menstrual cycle, ultrasound will be performed and gonadotropin rFSH will be injected daily and will be randomly divided into two groups.In Fixed group ,from the 5th day of gonadotropin administration while in Flexible group if there was a dominant follicle 12- 14 mm , Cetrotide will be administered daily and will be continue until the trigger day.
Main outcome variables
The number of M2 oocyte
General information
Reason for update
Update clinical trial based on the latest changes in the method and recruiment dates
Acronym
IRCT registration information
IRCT registration number:IRCT20091018002604N6
Registration date:2023-10-09, 1402/07/17
Registration timing:prospective
Last update:2024-05-12, 1403/02/23
Update count:1
Registration date
2023-10-09, 1402/07/17
Registrant information
Name
Robab Davar
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 7085
Email address
davar@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-12, 1402/07/20
Expected recruitment end date
2024-02-29, 1402/12/10
Actual recruitment start date
2023-10-12, 1402/07/20
Actual recruitment end date
2024-02-29, 1402/12/10
Trial completion date
empty
Scientific title
Evaluation and comparison of Fixed versus Flexible Gonadotropin Releasing Hormone Antagonist Protocol in Controlled Ovarian Stimulation for In vitro Fertilization in Women with Polycystic Ovary Syndrome- A randomized clinical trial
Public title
Evaluation of Fixed versus Flexible Gonadotropin Releasing Hormone Antagonist Protocol for In vitro Fertilization in Women with Polycystic Ovary Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with Polycystic Ovary Syndrome (PCOS) candidate for ART(Assisted Reproductive Techniques)
Age in range of 20-40 years
BMI in range of 20-30 kg/m2
Exclusion criteria:
Sever endometriosis
Sever male factor infertility
Pelvic neoplasia
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
150
Actual sample size reached:
150
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the software 'Random Allocation1' (https://random-allocation-software.software.informer.com/1.0/), and based on the simple randomization method, a statistician will produce the list of samples for the two study groups. In this software, to generate a list of random numbers, we will first determine the number of study groups and the total number of samples (2 and 150, respectively). Then, from the list of sample randomization methods, we will choose the simple randomization method for parallel groups, ensuring an equal number of samples in both groups. Subsequently, a random list based on the groups and the number of samples in each group will be generated.The randomized unit will be the referring person, who will be randomly assigned to each group by the researcher after obtaining informed consent and according to the generated list. To maintain the concealment of randomization, we will use the sealed envelope method. These envelopes will be prepared in the same quantity as the samples and will contain the name of the intervention group.
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 Yazd reproductive Sience Institute- Shahid Sadoghi University of Medical Science
Street address
Yazd Reproductive Sciences Institute, BouAl Ave,Safaeih، Yazd, Yazd Province
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۸۷۷۳۹۱
Approval date
2023-08-06, 1402/05/15
Ethics committee reference number
IR.SSU.RSI.REC.1402.013
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
The number of M II oocytes
Timepoint
After ovarian puncture
Method of measurement
Microscopic manual counting by embryologist
Secondary outcomes
1
Description
The number of embryos with qualities of A,B,or C.
Timepoint
1-2 days after ovarian puncture
Method of measurement
Microscopic manual counting by embryologist
2
Description
The duration of controlled ovarian stimulation period
Timepoint
Immediatly after controlled ovarian stimulation
Method of measurement
Time scale(day)
3
Description
The dosage of Gonadotropin used
Timepoint
After controlled ovarian stimulation
Method of measurement
Counting
4
Description
The number of Cetrotide injections
Timepoint
After controlled ovarian stimulation
Method of measurement
Counting
5
Description
The incidence of OHSS(Ovarian Hyperstimulation Syndrome)
Timepoint
3_7 days after trigger
Method of measurement
Through phisycal examination and Ultra sonography
Intervention groups
1
Description
Intervention group 1: (Fixed group) on the second day of the menstrual cycle, ultrasound will be performed and 150 IU rFSH gonadotropin will be injected daily . Then, starting from the fifth day of gonadotropin administration, 0.25 mg of sterotide will be administered daily until the trigger day. In both groups, with ultrasound monitoring when there are at least 2 follicles ≥17 mm in size, triggering with HCG (1500-5000 IU) and GnRH agonist or GnRH agonist alone will be done. 34-36 hours after the trigger, ovarian puncture will be performed under general anesthesia and ultrasound guidance. 72 hours after ovarian puncture, one or two cleavage stage embryos will be transfered, the rest of the embryos will be frozen. If there is a risk of Ovarian Hyperstimulation syndrome(OHSS) or serum progesterone level ≥ 2.25 ng/ml, all embryos will be frozen. OHSS in the form of follicle count ≥ 25 or serum estradiol level ≥4000, is defined.
Category
Treatment - Drugs
2
Description
Intervention group 2: (Flexible group) From the second day of the menstrual cycle, daily subcutaneous gonadotropin IU150 rFSH was started, then if there was a dominant follicle 12-14 mm, Cetrotide 0.25 mg was prescribed and it will continue until the trigger day. In both groups, with ultrasound monitoring, when there are at least 2 follicles ≥17 mm, triggering with HCG (1500-5000 IU) and GnRH agonist or GnRH agonist alone will be done . 34- 36 hours after the trigger, ovarian puncture will be performed under general anesthesia and ultrasound guidance. 72 hours after ovarian puncture, one or two cleavage stage embryos will be transfered and the rest of the embryos will be frozen. If there is a risk of Ovarian Hyperstimulation Syndrome (OHSS) or serum progesterone level ≥ 2.25 ng/ml, all Embryos will be frozen.OHSS is defined as follicle count ≥25 or serum estradiol level ≥4000.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Reproductive Sciences Institute
Full name of responsible person
Hanie Fatehi
Street address
Yazd Reproductive Sciences Institute, BouAl Ave,Safaeih، Yazd, Yazd Province
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۸۷۷۳۹۱
Phone
+98 35 3824 7085
Email
info@Yazd-RSI.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi Abargouei
Street address
Bahonar Ave
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Email
dvc.research@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hanieh Fatehi
Position
fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yazd Reproductive Sciences Institute, BouAl Ave,Safaeih، Yazd, Yazd Province
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۸۷۷۳۹۱
Phone
+98 35 3824 7085
Email
dr.fatehi435@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hanieh Fatehi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yazd Reproductive Sciences Institute, BouAl Ave,Safaeih، Yazd, Yazd Province
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۸۷۷۳۹۱
Phone
+98 35 3824 7085
Email
dr.fatehi435@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hanieh Fatehi
Position
fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yazd Reproductive Sciences Institute, BouAl Ave,Safaeih، Yazd, Yazd Province
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۸۷۷۳۹۱
Phone
+98 35 3824 7085
Email
dr.fatehi435@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All participant data sets are to be shared
When the data will become available and for how long
2 months after the result publication
To whom data/document is available
In order to receive data or other study documents, researchers working in academic and scientific institutions are allowed to apply.
Under which criteria data/document could be used
To evaluate the accuracy of the data and use data to complete other researches
From where data/document is obtainable
Yazd Reproductive Sciences Institute, Bouali Ave, Yazd, Iran
What processes are involved for a request to access data/document
Request from the Research Deputy, submitted to the Research Council of the Center if the request accepts its referral to the security and after completion of the relevant forms, the request is referred to the research experts and then get the data.