The effect of intrauterine human chorionic gonadotropin injection before embryo transfer on the implantation and pregnancy rate in infertile patients: A randomized clinical trial
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General information
39
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Recruitment centers
#1
Name of recruitment center - English: Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Science ,Yazd
Name of recruitment center - Persian: مركز تحقيقاتي درماني ناباروري, دانشگاه علوم پزشكي شهيد صدوقي يزد
Full name of responsible person - English: Dr.Sima Janati
Full name of responsible person - Persian: دکتر سیما جنتی
Street address - English: Boali Ave, Safayeh , Research and Clinical Center for Infertility,Yazd
Street address - Persian: یزد، صفائيه، خیابان بوعلی ، مرکزتحقیقاتی و درمانی ناباروری
City - English: Yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: ۸۹۱۶۸۷۷۳۹۱
Phone: +98 35 3824 7085
Fax:
Email: yazd-rsi@ssu.ac.ir
Web page address:
Name of recruitment center - English: Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Science ,Yazd
Name of recruitment center - Persian: مركز تحقيقاتي درماني ناباروري, دانشگاه علوم پزشكي شهيد صدوقي يزد
Full name of responsible person - English: Dr.Sima Janati
Full name of responsible person - Persian: دکتر سیما جنتی
Street address - English: Research and Clinical Center for Infertility, Boali Ave, Safayeh , Yazd
Street address - Persian: یزد، صفائيه، خیابان بوعلی ، مرکزتحقیقاتی و درمانی ناباروری
City - English: Yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: ۸۹۱۶۸۷۷۳۹۱
Phone: +98 35 3824 7085
Fax:
Email: yazd-rsi@ssu.ac.ir
Web page address:
Name of recruitment center - English: Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Science ,Yazd Name of recruitment center - Persian: مركز تحقيقاتي درماني ناباروري, دانشگاه علوم پزشكي شهيد صدوقي يزد Full name of responsible person - English: Dr.Sima Janati Full name of responsible person - Persian: دکتر سیما جنتی Street address - English: Boali Ave, Safayeh , Research and Clinical Center for Infertility,YazdInfertility, Boali Ave, Safayeh , Yazd Street address - Persian: یزد، صفائيه، خیابان بوعلی ، مرکزتحقیقاتی و درمانی ناباروری City - English: Yazd City - Persian: یزد Province: Yazd Country: Iran (Islamic Republic of) Postal code: ۸۹۱۶۸۷۷۳۹۱ Phone: +98 35 3824 7085 Fax: Email: yazd-rsi@ssu.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vise Canceler of Shahid Sadoughi University of Medical Sciences of Yazd, Research and Clinical Cente
Name of organization / entity - Persian: معاونت پژو هشی دانشگاه علوم پزشکی شهید صدوقی یزد، مرکزتحقیقاتی و درمانی ناباروری
Full name of responsible person - English: Dr. Razieh Dehghani Firouzabadi
Full name of responsible person - Persian: دکتر راضیه دهقانی فیروز آبادی
Street address - English: Bouali Ave,Safayeh, Research and Clinical Center for Infertility, Yazd
Street address - Persian: یزد، صفاییه، خیابان بوعلی، مرکز تحقیقاتی و درمانی ناباروری
City - English: Yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: ۸۹۱۶۸۷۷۳۹۱
Phone: +98 35 3824 7085
Fax:
Email: yazd-rsi@ssu.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Vise Canceler of Shahid Sadoughi University of Medical Sciences of Yazd, Research and Clinical Cente
Name of organization / entity - Persian: معاونت پژو هشی دانشگاه علوم پزشکی شهید صدوقی یزد، مرکزتحقیقاتی و درمانی ناباروری
Full name of responsible person - English: Dr. Razieh Dehghani Firouzabadi
Full name of responsible person - Persian: دکتر راضیه دهقانی فیروز آبادی
Street address - English: Research and Clinical Center for Infertility, Bouali Ave, Safayeh, Yazd
Street address - Persian: یزد، صفاییه، خیابان بوعلی، مرکز تحقیقاتی و درمانی ناباروری
City - English: Yazd
City - Persian: یزد
Province: Yazd
Country: Iran (Islamic Republic of)
Postal code: ۸۹۱۶۸۷۷۳۹۱
Phone: +98 35 3824 7085
Fax:
Email: yazd-rsi@ssu.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vise Canceler of Shahid Sadoughi University of Medical Sciences of Yazd, Research and Clinical Cente Name of organization / entity - Persian: معاونت پژو هشی دانشگاه علوم پزشکی شهید صدوقی یزد، مرکزتحقیقاتی و درمانی ناباروری Full name of responsible person - English: Dr. Razieh Dehghani Firouzabadi Full name of responsible person - Persian: دکتر راضیه دهقانی فیروز آبادی Street address - English: Bouali Ave,Safayeh, Research and Clinical Center for Infertility, Bouali Ave, Safayeh, Yazd Street address - Persian: یزد، صفاییه، خیابان بوعلی، مرکز تحقیقاتی و درمانی ناباروری City - English: Yazd City - Persian: یزد Province: Yazd Country: Iran (Islamic Republic of) Postal code: ۸۹۱۶۸۷۷۳۹۱ Phone: +98 35 3824 7085 Fax: Email: yazd-rsi@ssu.ac.ir Web page address:
Protocol summary
Study aim
This study aims to investigate the effect of intrauterine human chorionic gonadotropin injection before embryo transfer on the implantation and pregnancy rate in infertile women.
Design
Clinical trial with control group, parallel, phase 2 on 159 patients (n=53/each group), random number table was used for randomization.
Settings and conduct
159 participants undergoing In vitro Fertilization/ Intracytoplasmic Sperm Injection (IVF/ICSI) with an antagonist protocol referring to Yazd Research and Clinical Center for infertility will be evaluated from April 2012 to March 2013 will be evaluated. Patients will be divided into 3 groups (n=53) by using computer-generated random numbers. Randomization was simple, individual using a random number table and the ratio of 1:1. In this study, Blinding was not done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women aged 20-40 years with male factor or unexplained infertility and basal FSH less than 12.
Intervention groups
Group 1 will receive 500 IU of human chorionic gonadotropin (hCG), group 2 will receive 1000 IU of hCG intrauterine injection before embryo transfer, and the control group will undergo embryo transfer (2-3 embryos) without hCG preceding intrauterine injection. Approximately 7 minutes after intrauterine HCG injection, 2-3 embryos will be transferred via another soft catheter (Cook). For luteal phase support, intramuscular injection of 100 mg progesterone will be used.
Main outcome variables
primary outcomes: Chemical and Clinical pregnancy rates, Implantation rate. secondary outcome: abortion rate
General information
Reason for update
Updating the date of sampling and the end of the clinical trial and things such as the exact mention of randomization, inclusion/exclusion criteria and study outcomes.
Acronym
IRCT registration information
IRCT registration number:IRCT2012091310328N3
Registration date:2013-01-12, 1391/10/23
Registration timing:registered_while_recruiting
Last update:2022-11-09, 1401/08/18
Update count:2
Registration date
2013-01-12, 1391/10/23
Registrant information
Name
Sima Janati
Name of organization / entity
Research and Clinical Center for Infertility, Dezful University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 4242 9781
Email address
janati@dums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research and Clinical Center for Infertility, Shahid sadoughi university of medical sciences, Yazd
Expected recruitment start date
2012-04-05, 1391/01/17
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
2012-04-05, 1391/01/17
Actual recruitment end date
2013-03-19, 1391/12/29
Trial completion date
2013-09-20, 1392/06/29
Scientific title
The effect of intrauterine human chorionic gonadotropin injection before embryo transfer on the implantation and pregnancy rate in infertile patients: A randomized clinical trial
Public title
The effect of intrauterine human chorionic gonadotropin injection on pregnancy outcomes in infertile patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
female
age in the range of 20-40 years
male factor infertility
unexplained infertility
basal FSH less than 12.
Exclusion criteria:
azoospermia,
presence of uterine myoma
endometriosis
hydrosalpinges
previous IVF/ICSI trials (successful or unsuccessful)
history of endocrine diseases such as diabetes and thyroid dysfunction
previous history of hysterocopic operation due to submoucosal myoma, and intrauterine synechia.
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:
159
Actual sample size reached:
159
Randomization (investigator's opinion)
Randomized
Randomization description
Women who met the inclusion criteria were numbered from 1 to 159 in order of referral. After being explained about the study method and obtaining informed consent two columns of 53 random numbers from 1-159 were produced using statistical soft version Minitab 14 software (Minitab. LLC, 2014. Minitab, Available at: http://www.minitab.com); numbers that were not in these columns were considered as third group. Each lists was randomly assigned to one of the intervention groups A, B and C (control). The simple randomization method was used. Envelopes and codes were assigned for all participants. Group one was marked with A, group two with B and group three with C. A code has been assigned to each envelope and this code was recorded for each participant.
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
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences,Yazd
Street address
Research and Clinical Center for Infertility, Bouali Ave, Safayeh, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۸۷۷۳۹۱
Approval date
2012-03-15, 1390/12/25
Ethics committee reference number
3771
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N98.3
ICD-10 code description
Complications of attempted introduction of embryo in embryo transfe
Primary outcomes
1
Description
Implantation rate
Timepoint
Identified through vaginal or abdominal ultrasound 4-5 wks after the embryo transfer.
Method of measurement
Observation of number of gestational sacs by transvaginal ultrasonography per 100 embryo transfer
2
Description
Chemical pregnancy
Timepoint
2 weeks after embryo transfer
Method of measurement
BHCG test
3
Description
Clinical pregnancy
Timepoint
4 -5 weeks after embryo transfer
Method of measurement
observation of fetal heart activity by trans vaginal or abdominal ultrasound
Secondary outcomes
1
Description
Abortion
Timepoint
Before the 20th week of pregnancy
Method of measurement
Abortion product observation (placenta and fetus residual)
Intervention groups
1
Description
In control group (n=53) in time of monitoring when at least three follicles 18 mm to be seen on ultrasound, 10,000 units HCG will be injected. 36 hours after puncturing oocytes, IVF or ICSI will be performed and 48-72 hours after between 2-3 embryo through of Cook catheter embryo transfer (ET) will be performed. For luteal phase support progesterone 100 mg intramuscular injection will used .
Category
Treatment - Drugs
2
Description
In group 1 intervention (n=53) in time of monitoring when at least three follicles 18 mm to be seen on ultrasound, 10,000 units HCG will be injected. 36 hours after puncturing oocytes, IVF or ICSI will be performed. Culture media will added to a vial HCG 5000 IU and will be get HCG dilution requirement(500 unit)for intrauterine injection. In the second or third day after the oocyte pickup ,after inserting a speculum and view the cervix in lithotomy position and after will passed the internal cervical OS , 40 microliter of tissue culture medium containing 500 IU of hCG through a soft catheter( Cook) will injected intrauterine. Approximately 7minutes after intrauterine HCG injection, between 2-3 embryo through another soft catheter( Cook ) embryo transfer (ET) will be performed. For luteal phase support progesterone 100 mg intramuscular injection will used .
Category
Treatment - Drugs
3
Description
In group 2 intervention (n=53) in time of monitoring when at least three follicles 18 mm to be seen on ultrasound, 10,000 units HCG will be injected. 36 hours after puncturing oocytes, IVF or ICSI will be performed. Culture media will added to a vial HCG 5000 IU and will be get HCG dilution requirement(1000 unit)for intrauterine injection. In the second or third day after the oocyte pickup ,after inserting a speculum and view the cervix in lithotomy position and after will passed the internal cervical OS, 40 microliter of tissue culture medium containing 1000 IU of hCG through a soft catheter( Cook) will injected intrauterine. Approximately 7minutes after intrauterine HCG injection, between 2-3 embryo through another soft catheter( Cook ) embryo transfer (ET) will be performed. For luteal phase support progesterone 100 mg intramuscular injection will used .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Science ,Yazd
Full name of responsible person
Dr.Sima Janati
Street address
Research and Clinical Center for Infertility, Boali Ave, Safayeh , Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۸۷۷۳۹۱
Phone
+98 35 3824 7085
Email
yazd-rsi@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vise Canceler of Shahid Sadoughi University of Medical Sciences of Yazd, Research and Clinical Cente
Full name of responsible person
Dr. Razieh Dehghani Firouzabadi
Street address
Research and Clinical Center for Infertility, Bouali Ave, Safayeh, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۸۷۷۳۹۱
Phone
+98 35 3824 7085
Email
yazd-rsi@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vise Canceler of Shahid Sadoughi University of Medical Sciences of Yazd, Research and Clinical Cente
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
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences Yazd
Full name of responsible person
Dr.Sima Janati
Position
Assisted Professor of Obstetrics and Gynecology, fellowship of infertility in state of training
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Research and Clinical Center for Infertility, Bouali Ave, Safayeh,Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۸۷۷۳۹۱
Phone
+98 35 1824 7085
Fax
+98 35 1824 7087
Email
janati@dums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences,Yazd
Full name of responsible person
Dr.Razieh Dehghani Firouzabadi
Position
Associate professor of Obstetrics and Gynecology, fellow ship of infertility
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Research and Clinical Center for Infertility, Bouali Ave, Safayeh، Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۸۷۷۳۹۱
Phone
+98 35 1824 7085
Fax
+98 35 1824 7087
Email
dr-firouzabadi@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences Yazd
Full name of responsible person
Dr. Sima Janati
Position
Assisted professor of Obstetrics and Gynecology, fellowship of infertility in state of training
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Research and Clinical Center for Infertility, Bouali Ave, Safayeh, Yazd
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۸۷۷۳۹۱
Phone
+98 35 1824 7085
Fax
+98 35 1824 7087
Email
janati@dums.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
Researchers working in academic and scientific institutes, Journal editors and Reviewers
Under which criteria data/document could be used
Submission of an official application via the agent that is legally in charge
From where data/document is obtainable
Yazd Reproductive Sciences Institute, Bouali Ave, Yazd, Iran. 983538247085
What processes are involved for a request to access data/document
Immediately after the Submission of an official application via the agent that is legally in charge (About a month) by sending an email to janati@dums.ac.ir.