History
# Registration date Revision Id
4 2021-06-07, 1400/03/17 185466
3 2021-04-03, 1400/01/14 177071
2 2021-03-16, 1399/12/26 176526
1 2020-03-11, 1398/12/21 125077
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  • Protocol summary

    clinical trial with two parallel arm non randomized 100 patient group
    a clinical trial with two parallel arms non randomized patient group
    کارازمایی بالینی دارای گروه کنترل با دو گروه غیرتصادفی موازی 100 نفره
    کارازمایی بالینی دارای گروه کنترل با دو گروه غیرتصادفی موازی
  • General information

    3
    2
    empty
    172
    2019-09-23, 1398/07/01
    2020-01-01, 1398/10/11
    2020-04-19, 1399/01/31
    2020-03-30, 1399/01/11
    empty
    2020-01-01, 1398/10/11
    empty
    2020-03-30, 1399/01/11
    empty
    2641-08-06, 2020/05/15
    empty
    Updating the trial according to the last changes in methods
    empty
    بروزرسانی کارآزمایی بر اساس آخرین تغییرات روش کار
    age 20-39 years
    fresh embryo transfer cycles
    age 20-39 years
    fresh embryo transfer cycles
    HCG -triggered cycles
    سن بین 20-39 سال
    سیکل های انتقال جنین تازه
    سن بین 20-39 سال
    سیکل های انتقال جنین تازه
    سیکلهای که با HCG تریگر میشوند
    absence of good quality embryo
    ovarian hyper stimulation (more than 18 mature follicle during ovarian stimulation)
    severe male factor
    low ovarian response
    Absence of good quality embryo
    Ovarian hyper stimulation (more than 18 mature follicles during ovarian stimulation)
    Severe male factor
    عدم تشکیل جنین با کیفیت مطلوب
    پاسخ شدید تخمدانی ( بروز بیشتر از 18 فولیکول با سایز 18 میلی متر یا بیشتر در حین تحریک تخمدانی )
    ناباروري شدید مردانه
    پاسخ ضعیف تخمدان
    عدم تشکیل جنین با کیفیت مطلوب
    پاسخ شدید تخمدانی ( بروز بیشتر از 18 فولیکول با سایز 18 میلی متر یا بیشتر در حین تحریک تخمدانی )
    ناباروري شدید مردانه
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Vice Chancellor for research of Shahid Sadoughi University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی و خدمات بهداشتی درمانی شهید صدوقی یزد
    Full name of responsible person - English: Dr.Maryam Eftekhar
    Full name of responsible person - Persian: دکتر مریم افتخار
    Street address - English: Research and Clinical Center for Infertility, Bouali, Timsar Fallahy, Safayeh, Yazd
    Street address - Persian: یزد، صفاییه، خیابان تیمسار فلاحی، خیابان بوعلی، مرکز تحقیقاتی و درمانی ناباروری یزد
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8916877391
    Phone: +98 35 3824 7085
    Fax:
    Email: info@yazd-rsi-ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Yazd University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی یزد
    Full name of responsible person - English: Masoud Mirzaei
    Full name of responsible person - Persian: مسعود میرزایی
    Street address - English: Shahid Sadoughi
    Street address - Persian: شهید صدوقی
    City - English: Yazd
    City - Persian: یزد
    Province: Yazd
    Country: Iran (Islamic Republic of)
    Postal code: 8916978477
    Phone: +98 35 3724 0171
    Fax:
    Email: masoud_mirzaei@hotmail.com
    Web page address:

Protocol summary

Study aim
Influence of GNRH agonist in luteal phase support for assisted reproductive techniques
Design
a clinical trial with two parallel arms non randomized patient group
Settings and conduct
20-39 years old infertile normal responder patients candidate for IVF,divide to two non randomized parallel group,in case group we inject 0.1mg triptorlin in days 0-3-6 plus 400 mg intravaginal cyclogest twice daily.in control group we just prescribe 400 mg intra vaginal cyclogest twice daily for luteal phase support. 2 weeks after tansfering serum BHCG will check and 2 weeks after positive BHCG,vaginal sonography for checking gestatioal sac and fetal heart rate will be done.
Participants/Inclusion and exclusion criteria
Inclusion criteria :Age between 20-39 years-fresh embryo transfer cycles- Exclusion criteria : uterine anomaly-low ovarian response ovarian hyper stimulation-oocyte donation-sever endothriosis
Intervention groups
Infertile women with normal ovarian response that subcutaneus inject of triptorelin 0/1 mg 0-3-6 days after fresh transfer
Main outcome variables
Chemical pregnancy-clinical pregnancy

General information

Reason for update
Updating the trial according to the last changes in methods
Acronym
IRCT registration information
IRCT registration number: IRCT20110509006420N20
Registration date: 2020-03-11, 1398/12/21
Registration timing: registered_while_recruiting

Last update: 2021-03-28, 1400/01/08
Update count: 3
Registration date
2020-03-11, 1398/12/21
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
Expected recruitment start date
2020-01-01, 1398/10/11
Expected recruitment end date
2020-03-30, 1399/01/11
Actual recruitment start date
2020-01-01, 1398/10/11
Actual recruitment end date
2020-03-30, 1399/01/11
Trial completion date
2641-08-06, 2020/05/15
Scientific title
Effects of GnRH agonist for luteal phase support in assisted reproductive cycles
Public title
Effects of GnRH agonist for luteal phase support
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age 20-39 years fresh embryo transfer cycles HCG -triggered cycles
Exclusion criteria:
Absence of good quality embryo Ovarian hyper stimulation (more than 18 mature follicles during ovarian stimulation) Severe male factor
Age
From 20 years old to 39 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 200
Actual sample size reached: 172
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Research and Clinical Center for infertility, Shahid Sadoughi University of
Street address
Bouali Ave, Safaeiyeh
City
Yazd
Province
Yazd
Postal code
8916877391
Approval date
2019-12-29, 1398/10/08
Ethics committee reference number
IR.SSU.RSI.REC.1398.043

Health conditions studied

1

Description of health condition studied
female infertility
ICD-10 code
N97
ICD-10 code description
Female infertility

Primary outcomes

1

Description
Chemical pregnancy
Timepoint
2 weeks after embryo transfer
Method of measurement
serum BHCG

2

Description
clinical pregnancy
Timepoint
6 weeks after embryo transfer
Method of measurement
sonography

Secondary outcomes

empty

Intervention groups

1

Description
taking 0/1 mg triptorelin in 0-3-6 days after fresh emeryo transfer plus 400mg vaginal cyclogest twice daily for luteal phase support.
Category
Treatment - Drugs

2

Description
Control group: taking 400mg vaginal cyclogest twice daily for luteal phase support.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd Research and Clinical Center for Infertility
Full name of responsible person
Dr. Maryam Eftekhar
Street address
Boali Ave., Safayeh
City
Yazd
Province
Yazd
Postal code
8916877391
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
Masoud Mirzaei
Street address
Shahid Sadoughi
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
masoud_mirzaei@hotmail.com
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
Maryam Eftekhar
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali Ave, Safaeyeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35182470856
Fax
+98 35 1824 7087
Email
eftekhar@ssu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Eftekhar
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali Ave, Safaeyeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35182470856
Fax
+98 35 1824 7087
Email
eftekhar@ssu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Mirzaei
Position
fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Research and Clinical Center for Infertility, Bouali, Timsar Fallahy, Safayeh, Yazd
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
maryammirzaei@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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