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Evaluation of pregnancy outcome after Transfer of Blastocysts derived from Frozen –Thawed cleavage stage embryos

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History
# Registration date Revision Id
3 2021-03-16, 1399/12/26 177036
2 2021-03-04, 1399/12/14 173775
1 2011-09-01, 1390/06/10 6865
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  • Protocol summary

    The aim of our study was to compare the resulting from transfer of embryos that cryopereserved in cleavage stage after thawing and transfer of embryos after thawing and culture in sequentional media until blastocyst formation. Methods and materials: In this prospective clinical study, we evaluate128 cycles in women undergone in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) with embryo cryopreservation. Exclusion criteria were women with age >38 years and azospermia.Frozen embryos were thawed and then cultured in sequential media until blastocyst stage in blastocyst group and were compared with thawed embryos in cleavage stage group. The primary outcome is chemical pregnancy rates.
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    هدف مطالعه مقایسه نتایج حاصل از انتقال جنین فریز شده در مرحله تقسیم بعد از ذوب شدن با انتقال جنینهای فریز شده در مرحله تقسیم و سپس کشت در محیط کشت چند مرحله ای تا زمان تشکیل بلاستوسیست میباشد. در این مطالعه آینده نگر 128 بیمار که تحت لقاح داخل آزمایشگاهی یا میکروانجکشن و فریز جنین قرار میگرند بررسی میشوند .کرایتریای خروج شامل سن بالای 38 سال و ازواسپرمی میباشد. در گروه بلاستوسیست جنینهای فریز شده ذوب میشوند و در محیط کشت تا مرحله بلاستوسیت کشت داده میشوند و با جنینهای ذوب شده که در مرحله تقسیم سلولی منتقل شده اند مقایسه میشوند. پیامد اولیه حاملگی شیمیایی میباشد
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    The aim of this study was to compare implantation and pregnancy rates from vitrified-thawed cleavage-stage embryos which were cultured further to the blastocyst stage versus vitrified-thawed cleavage-stage embryos
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    هدف از این مطالعه مقایسه میزان لانه گزینی و حاملگی در جنینهای برگشت از فریز که در مرحله بلاستوسیست و یا کلیواژ منتقل شده اند.
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    134 women had previously undergone in vitro fertilization (IVF) or intra-cytoplasmic sperm injection (ICSI) with embryo cryopreservation in a randomized clinical trial without a control group, parallel trial without blindness, phase 2 were randomly divided into two groups.
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    134 زن با سابقه انجام لقاح خارج رحمی به روش IVF/ICSI و جنین فریز در یک کارآزمایی بالینی بدون گروه کنترل، با گروه های موازی ، بدون کورسازی ، تصادفی شده، فاز 2 با استفاده از جدول اعداد تصادفی به دو گروه تقسیم شدند.
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    134 women had previously undergone in vitro fertilization (IVF) or intra-cytoplasmicsperm injection (ICSI) with embryo cryopreservation in Yazd Reserch and Clinical center for Infertilty. The patients were randomly divided into group I (blastocyst group) and group II (cleavage group).
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    134 زن که سابقه انجام لقاح خارج رحمی به روش IVF/ICSI و جنین فریز داشته اند، در مرکز تحقیقاتی و درمانی ناباروری یزد بخ صورت رندوم به دو گروه با انتقال بلاستوسیست و انتقال کلیواژ تقسیم شدند.
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    All women had previously undergone in vitro fertilization (IVF) or intra-cytoplasmicsperm injection (ICSI) with embryo cryopreservation. Women with age>35 years, body mass index (BMI)>30 kg/m2, history of diabetes mellitus, thyroid diseaseand severe endometriosis were excluded from the study. Oocyte donation cycles were excluded from the study as well.
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    زنان با سابقه انجام لقاح خارج رحمی به روش IVF/ICSI و دارابودن جنین فریز وارد مطالعه شدند. زنان با سن بالای 35، شاخص توده بدنی بالای 30، سابقه دیابت، تیروئید، و اندومتریوز شدیدو سیکلهای تخمک اهدایی از مطالعه خارج شدند.
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    group I: embryos were transferred in the blastocyst stage group II: embryos were transferred in the cleavage stage
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    گروه 1:ترانسفر امبریوها در مرحله بلاستوسیست گروه 2: ترانسفر امبریوها در مرحله کلیواژ
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    Chemical, Clinical and ongoing pregnancy rates
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    حاملگی شیمیایی، بالینی و رو به پیشرفت

  • General information

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    134
    2011-01-01, 1389/10/11
    2009-01-01, 1387/10/12
    2012-03-01, 1390/12/11
    2011-06-30, 1390/04/09
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    2009-01-01, 1387/10/12
    empty
    2011-06-30, 1390/04/09
    empty
    2011-09-30, 1390/07/08
    empty
    Updating the trial according to the last changes in methods and adding results
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    به روز رسانی کارازمایی بالینی بر اساس آخرین تغییرات و اضافه کردن نتایج
    women underwent previously in vitro fertilization (IVF) or intra-cytoplasmicsperm injection (ICSI) with embryo cryopreservation
    ناني كه تحت درمان ناباروري با روش آي. وي. اف يا ميكرواينجكشن قرار گرفته و جنين فريز شده دارند.
    history of diabetes mellitus
    thyroid disease
    severe endometriosis
    Oocyte donation cycles
    Women with age>35 years
    body mass index (BMI)>30 kg/m2
    سابقه دیابت
    بیماری تیروئید
    اندومتریوز شدید
    سیکلهای با انتقال تخمک
    زنان بالای 35 سال
    شاخص توده بدنی > 30
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    The patients were divided into group I (blastocyst group) and group II (cleavage group) at the time of disclosing the sealed envelopes by computerized randomization.
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    بیماران با استفاده از تصادفی سازی کامپیوتری به دو گروه بلاستوسیت و کلیواژ تقسیم شدند.
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  • Primary outcomes

    #1
    12 days after embryo transfer
    14 days after embryo transfer
    12 روز پس از انتقال جنين
    14 روز پس از انتقال جنين
    #2
    empty
    Ongoing pregnancy
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    حاملگی رو به پیشرفت
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    12 weeks after embryo transfer
    empty
    12 هفته پس از انتقال جنین
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    ultrasonography
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    سونوگرافی

  • Recruitment centers

    #1
    Name of recruitment center - English: Yazd Research and Clinical Center for Infertility
    Name of recruitment center - Persian: مركز تحقيقاتي و درماني ناباروري يزد
    Full name of responsible person - English: Maryam Eftekhar
    Full name of responsible person - Persian:
    Street address - English:
    Street address - Persian:
    City - English: Yazd
    City - Persian: يزد
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Yazd Research and Clinical Center for Infertility
    Name of recruitment center - Persian: مركز تحقيقاتي و درماني ناباروري يزد
    Full name of responsible person - English: Maryam Eftekhar
    Full name of responsible person - Persian: مریم افتخار
    Street address - English: Bouali ave
    Street address - Persian: خیابان بوعلی
    City - English: Yazd
    City - Persian: يزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8916877391
    Phone: +98 35 3824 7085
    Fax:
    Email: eftekharmaryam@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Yazd research and clinical center for infertility
    Name of organization / entity - Persian: مركز تحقيقاتي و درماني ناباروري يزد
    Full name of responsible person - English: Dr.Abbas Aflatoonian
    Full name of responsible person - Persian: دکتر عباس افلاطونیان
    Street address - English: Bouali avenue , Safaieh
    Street address - Persian: صفائیه,خیابان بوعلی,
    City - English: Yazd
    City - Persian: يزد
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Yazd research and clinical center for infertility
    Name of organization / entity - Persian: مركز تحقيقاتي و درماني ناباروري يزد
    Full name of responsible person - English: Dr.Abbas Aflatoonian
    Full name of responsible person - Persian: دکتر عباس افلاطونیان
    Street address - English: Bouali avenue , Safaieh
    Street address - Persian: صفائیه,خیابان بوعلی,
    City - English: Yazd
    City - Persian: يزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8916877391
    Phone: +98 35 3824 7085
    Fax:
    Email: abbas_aflatoonian@yahoo.com
    Web page address:
    empty
    Public
    empty
    Domestic
    empty
    Academic

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: YAazd Research and Clinical Center for Infertility
    Name of organization / entity - Persian: مركز تحقيقاتي و درماني ناباروري يزد
    Full name of responsible person - English: Maryam Eftekhar
    Full name of responsible person - Persian: مريم افتخار
    Position - English: Gynecologist,MD
    Position - Persian: متخصص زنان و زايمان
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Bouali avenue , Safaieh
    Street address - Persian: صفائیه,خیابان بوعلی
    City - English: Yazd
    City - Persian: يزد
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 35 1824 7085
    Mobile:
    Fax:
    Email: eftekhar@ssu.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: YAazd Research and Clinical Center for Infertility
    Name of organization / entity - Persian: مركز تحقيقاتي و درماني ناباروري يزد
    Full name of responsible person - English: Maryam Eftekhar
    Full name of responsible person - Persian: مريم افتخار
    Position - English: Gynecologist,MD
    Position - Persian: متخصص زنان و زايمان
    Latest degree: specialist
    Area of specialty/work: 49
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Bouali avenue , Safaieh
    Street address - Persian: صفائیه,خیابان بوعلی
    City - English: Yazd
    City - Persian: يزد
    Province: Yazd
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8916877391
    Phone: +98 35 1824 7085
    Mobile: +98 913 156 3078
    Fax:
    Email: eftekhar@ssu.ac.ir
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Yazd research and clinical center for infertility
    Name of organization / entity - Persian: مرکز تحقیقاتی و درمانی ناباروری یزد
    Full name of responsible person - English: Maryam Eftekhar
    Full name of responsible person - Persian: مريم افتخار
    Position - English: Gynecologist,MD
    Position - Persian: متخصص زنان زايمان و نازايي
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Bouali avenue , Safaieh
    Street address - Persian: صفائیه,خیابان بوعلی
    City - English: Yazd
    City - Persian: يزد
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 35 1824 7085
    Mobile:
    Fax:
    Email: eftekhar@ssu.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Yazd research and clinical center for infertility
    Name of organization / entity - Persian: مرکز تحقیقاتی و درمانی ناباروری یزد
    Full name of responsible person - English: Maryam Eftekhar
    Full name of responsible person - Persian: مريم افتخار
    Position - English: Gynecologist,MD
    Position - Persian: متخصص زنان زايمان و نازايي
    Latest degree: specialist
    Area of specialty/work: 49
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Bouali avenue , Safaieh
    Street address - Persian: صفائیه,خیابان بوعلی
    City - English: Yazd
    City - Persian: يزد
    Province: Yazd
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8916877391
    Phone: +98 35 1824 7085
    Mobile: +98 913 156 3078
    Fax:
    Email: eftekhar@ssu.ac.ir
    Web page address:

  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Yazd research and clinical center for infertility
    Name of organization / entity - Persian: مركز تحقيقاتي و درماني ناباروري يزد
    Full name of responsible person - English: Maryam Eftekhar
    Full name of responsible person - Persian: مريم افتخار
    Position - English:
    Position - Persian: استادیار زنان
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Bouali avenue ,safaieh
    Street address - Persian: صفاییه خیابان بوعلی
    City - English: Yazd
    City - Persian: یزد
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 35 1824 7085
    Mobile: +98 913 156 3078
    Fax:
    Email: eftekhar@ssu.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Yazd research and clinical center for infertility
    Name of organization / entity - Persian: مركز تحقيقاتي و درماني ناباروري يزد
    Full name of responsible person - English: Maryam Eftekhar
    Full name of responsible person - Persian: مريم افتخار
    Position - English: Professor
    Position - Persian: استاد
    Latest degree: specialist
    Area of specialty/work: 49
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Bouali avenue ,safaieh
    Street address - Persian: صفاییه خیابان بوعلی
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 8916877391
    Phone: +98 35 1824 7085
    Mobile: +98 913 156 3078
    Fax:
    Email: eftekhar@ssu.ac.ir
    Web page address:

  • Sharing plan

    yes
    yes
    yes
    yes
    yes
    yes
    yes
    empty
    All participant data sets are to be shared
    empty
    کل داده ها بالقوه پس از غیر قابل شناسایی کردن افراد قابل اشتراک گذاری است
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    2 months after the result publication
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    2 ماه بعد از چاپ نتایج
    empty
    A journal in which the results are published
    empty
    ژورنال چاپ کننده نتایج
    empty
    Submission of an official application via the agent that is legally incharge
    empty
    درخواست رسمی از طریق مرجع قانونی
    empty
    Yazd Reproductive Sciences Institute, Bouali Ave, Yazd, Iran. 983538247085 eftekharmaryam@yahoo.com
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    پژوهشکده علوم تولید مثل یزد، خیابان بوعلی، یزد، ایران. 983538247085 eftekharmaryam@yahoo.com
    empty
    2 months after application
    empty
    2 ماه پس از چاپ نتایج

Protocol summary

Study aim
The aim of this study was to compare implantation and pregnancy rates from vitrified-thawed cleavage-stage embryos which were cultured further to the blastocyst stage versus vitrified-thawed cleavage-stage embryos
Design
134 women had previously undergone in vitro fertilization (IVF) or intra-cytoplasmic sperm injection (ICSI) with embryo cryopreservation in a randomized clinical trial without a control group, parallel trial without blindness, phase 2 were randomly divided into two groups.
Settings and conduct
134 women had previously undergone in vitro fertilization (IVF) or intra-cytoplasmicsperm injection (ICSI) with embryo cryopreservation in Yazd Reserch and Clinical center for Infertilty. The patients were randomly divided into group I (blastocyst group) and group II (cleavage group).
Participants/Inclusion and exclusion criteria
All women had previously undergone in vitro fertilization (IVF) or intra-cytoplasmicsperm injection (ICSI) with embryo cryopreservation. Women with age>35 years, body mass index (BMI)>30 kg/m2, history of diabetes mellitus, thyroid diseaseand severe endometriosis were excluded from the study. Oocyte donation cycles were excluded from the study as well.
Intervention groups
group I: embryos were transferred in the blastocyst stage group II: embryos were transferred in the cleavage stage
Main outcome variables
Chemical, Clinical and ongoing pregnancy rates

General information

Reason for update
Updating the trial according to the last changes in methods and adding results
Acronym
IRCT registration information
IRCT registration number: IRCT201107306420N7
Registration date: 2011-09-01, 1390/06/10
Registration timing: retrospective

Last update: 2021-03-05, 1399/12/15
Update count: 2
Registration date
2011-09-01, 1390/06/10
Registrant information
Name
Maryam Eftekhar
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Country
Iran (Islamic Republic of)
Phone
+98 35182470856
Email address
eftekhar@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd research and clinical center for infertility
Expected recruitment start date
2009-01-01, 1387/10/12
Expected recruitment end date
2011-06-30, 1390/04/09
Actual recruitment start date
2009-01-01, 1387/10/12
Actual recruitment end date
2011-06-30, 1390/04/09
Trial completion date
2011-09-30, 1390/07/08
Scientific title
Evaluation of pregnancy outcome after Transfer of Blastocysts derived from Frozen –Thawed cleavage stage embryos
Public title
Transfer of Blastocysts in cryopreseved cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
women underwent previously in vitro fertilization (IVF) or intra-cytoplasmicsperm injection (ICSI) with embryo cryopreservation
Exclusion criteria:
history of diabetes mellitus thyroid disease severe endometriosis Oocyte donation cycles Women with age>35 years body mass index (BMI)>30 kg/m2
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 128
Actual sample size reached: 134
Randomization (investigator's opinion)
Randomized
Randomization description
The patients were divided into group I (blastocyst group) and group II (cleavage group) at the time of disclosing the sealed envelopes by computerized randomization.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Yazd Research and Clinical Center for Infertility, Yazd University of Medical Sciences
Street address
Safaeieh, Bouali Ave
City
Yazd
Province
Yazd
Postal code
8916877391
Approval date
2011-06-19, 1390/03/29
Ethics committee reference number
927

Health conditions studied

1

Description of health condition studied
Infertility
ICD-10 code
N98.9
ICD-10 code description
Complication associated with artificial fertilization, unspecified

Primary outcomes

1

Description
chemical pregnancy
Timepoint
14 days after embryo transfer
Method of measurement
blood laboartory kit

2

Description
clinical pregnancy
Timepoint
5 weeks after positive beta-hCG
Method of measurement
observation of fetal heart activity by transvaginal ultrasonography

3

Description
Ongoing pregnancy
Timepoint
12 weeks after embryo transfer
Method of measurement
ultrasonography

Secondary outcomes

1

Description
Miscarriage rate
Timepoint
lost of pregnancy before 20 gestational week
Method of measurement
absence of fetal heart activity in ultra sound sonography

Intervention groups

1

Description
Intervention: Thawing is done at least 2 months after cryopreservation. All embryos in group 1 (blastocyst group) transfer to media and extended culture is done for 3 days until blastocyst development. Endometrial preparation is done by estradiol valerate consumption orally at the dose of 6 mg per day from the second day of menstrual cycle. In day13 of cycle, an ultrasound examination is performed. It is used to assess endometrial thickness. When the endometrial thickness reaches more than 8 mm in diameter, 100 mg progestron is injected daily. Transfer of embryos is done 3 days after thawing and thawing is done 2 days after progestron injection. Estradiol and progesterone consumption is continued until the documentation of fetal heart activity by ultrasound .
Category
Treatment - Other

2

Description
Control: Thawing is done at least 2 months after cryopreservation. All embryos in group 2 (cleavage group) are transfered to uterine cavity 2 hours after thawing. Endometrial preparation is done by estradiol valerate consumption orally at the dose of 6 mg per day from the second day of menstrual cycle. In day13 of cycle, an ultrasound examination is performed. It is used to assess endometrial thickness. When the endometrial thickness reaches more than 8 mm in diameter, 100 mg progestron is injected daily. Thawing is done 2 days after progestron injection. Estradiol and progesterone consumption is continued until the documentation of fetal heart activity by ultrasound.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd Research and Clinical Center for Infertility
Full name of responsible person
Maryam Eftekhar
Street address
Bouali ave
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
eftekharmaryam@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd research and clinical center for infertility
Full name of responsible person
Dr.Abbas Aflatoonian
Street address
Bouali avenue , Safaieh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
abbas_aflatoonian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd research and clinical center for infertility
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
YAazd Research and Clinical Center for Infertility
Full name of responsible person
Maryam Eftekhar
Position
Gynecologist,MD
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali avenue , Safaieh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
Email
eftekhar@ssu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd research and clinical center for infertility
Full name of responsible person
Maryam Eftekhar
Position
Gynecologist,MD
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali avenue , Safaieh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
Email
eftekhar@ssu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yazd research and clinical center for infertility
Full name of responsible person
Maryam Eftekhar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali avenue ,safaieh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
Email
eftekhar@ssu.ac.ir
Web page address

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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is 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
A journal in which the results are published
Under which criteria data/document could be used
Submission of an official application via the agent that is legally incharge
From where data/document is obtainable
Yazd Reproductive Sciences Institute, Bouali Ave, Yazd, Iran. 983538247085 eftekharmaryam@yahoo.com
What processes are involved for a request to access data/document
2 months after application
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