Effect of sequential cleavage and blastocyst embryo transfer compared to one step cleavage embryo transfer on Assisted Reproductive Technology(ART) outcome of patients with at least two and maximum of five embryos, A randomized clinical trial
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General information
42
45
4245
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140
140
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2023-08-23, 1402/06/01
2023-08-23 00:00:00
empty
2024-01-20, 1402/10/30
2024-01-20 00:00:00
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2024-03-05, 1402/12/15
2024-03-05 00:00:00
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End of patient recruitment and termination of the clinical trial
End of patient recruitment and termination of the clinical trial
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پایان بیمار گیری و خاتمه کارآزمایی بالینی
پایان بیمار گیری و خاتمه کارآزمایی بالینی
Secondary outcomes
#1
Twin pregnancy
Early misscariage rate
Twin pregnancyEarly misscariage rate
بارداری دوقلویی
میزان سقط زودرس
بارداری دوقلوییمیزان سقط زودرس
At the gastational age of six week
Ten weeks after embryo transfer
At the gastational age of six weekTen weeks after embryo transfer
در هفته ۶ بارداری
ده هفته بعد از انتقال جنین
درده هفته ۶ بارداریبعد از انتقال جنین
Observation of two gestational sacs in Trans Vaginal Ultrasound
Absence of fetal heart activity in ultrasound
ObservationAbsence of two gestational sacsfetal heart activity in Trans Vaginal Ultrasoundultrasound
مشاهده دو ساک بارداری در سونوگرافی واژینال
عدم مشاهده ضربان قلب جنين در سونوگرافي
عدم مشاهده دو ساک بارداریضربان قلب جنين در سونوگرافی واژینالسونوگرافي
#2
Early misscariage rate
Ectopic pregnancy
Early misscariage rateEctopic pregnancy
میزان سقط زودرس
حاملگی خارج از رحم
میزان سقط زودرسحاملگی خارج از رحم
Ten weeks after embryo transfer
After positive result for chemical pregnancy
Ten weeks after embryo transferAfter positive result for chemical pregnancy
ده هفته بعد از انتقال جنین
بعد از اثبات بارداری شیمیایی
ده هفته بعد از انتقال جنیناثبات بارداری شیمیایی
Absence of fetal heart activity in ultrasound
No rise in serum Beta Hcg level and not visualizing intra uterine gestetianal sac in Trans Vaginal Ultrasound
Absence of fetal heart activityNo rise in ultrasoundserum Beta Hcg level and not visualizing intra uterine gestetianal sac in Trans Vaginal Ultrasound
عدم مشاهده ضربان قلب جنين در سونوگرافي
بالا نرفتن تیتر بتا اچ سی جی و عدم مشاهده ساک بارداری در سونوگرافی واژینال
بالا نرفتن تیتر بتا اچ سی جی و عدم مشاهده ضربان قلب جنينساک بارداری در سونوگرافيسونوگرافی واژینال
#3
Ectopic pregnancy
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Ectopic pregnancy
حاملگی خارج از رحم
empty
حاملگی خارج از رحم
After positive result for chemical pregnancy
empty
After positive result for chemical pregnancy
بعد از اثبات بارداری شیمیایی
empty
بعد از اثبات بارداری شیمیایی
No rise in serum Beta Hcg level and not visualizing intra uterine gestetianal sac in Trans Vaginal Ultrasound
empty
No rise in serum Beta Hcg level and not visualizing intra uterine gestetianal sac in Trans Vaginal Ultrasound
بالا نرفتن تیتر بتا اچ سی جی و عدم مشاهده ساک بارداری در سونوگرافی واژینال
empty
بالا نرفتن تیتر بتا اچ سی جی و عدم مشاهده ساک بارداری در سونوگرافی واژینال
Protocol summary
Study aim
Comparison of sequential transfer of one cleavage and one blastocyst embryo, whit transfer of two cleavage embryos, in increasing implantation rate in ART cycles
Design
Phase 3 clinical trial with a control group will be conducted in parallel groups on 140 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. 70 patients will be in the intervention group and 70 patients will be in the control group.
Settings and conduct
The clinical trial will be conducted in Yazd Infertility Research Center. The study and control cases will be selected among patients referring to the infertility clinic who are candidates for IVF. Patients who have two to five embryos in the IVF process after ovarian stimulation and oocyte puncture, and eligible for fresh embryo transfer, are randomly divided into two groups; sequential transfer of one cleavage embryo and one blastocyst group and simultaneous transfer of two cleavage embryos group. Blinding is not performed.
Participants/Inclusion and exclusion criteria
Infertile women aged 18-42, candidate for IVF/ICSI and eligible for fresh embryo transfer,with limitted number of embryos(2-5) whithout any structural or anathomical uterine problems.
Intervention groups
Both groups will be selected from infertile women candidate for IVF/ICSI and eligible for fresh embryo transfer.2 to 3 days after oocyte puncture, patients will return to know the number of their embryos. Patients who have a minimum of two and a maximum of five embryos will be randomly divided into two groups. Intervention group: sequential transfer of one cleavage embryo and one blastocyst embryo. Control group: transfer of two cleavage stage embryos at the same time.
Main outcome variables
Clinical pregnancy
General information
Reason for update
End of patient recruitment and termination of the clinical trial
Acronym
IRCT registration information
IRCT registration number:IRCT20110509006420N26
Registration date:2023-08-27, 1402/06/05
Registration timing:registered_while_recruiting
Last update:2024-03-30, 1403/01/11
Update count:1
Registration date
2023-08-27, 1402/06/05
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
2023-08-27, 1402/06/05
Expected recruitment end date
2024-01-05, 1402/10/15
Actual recruitment start date
2023-08-23, 1402/06/01
Actual recruitment end date
2024-01-20, 1402/10/30
Trial completion date
2024-03-05, 1402/12/15
Scientific title
Effect of sequential cleavage and blastocyst embryo transfer compared to one step cleavage embryo transfer on Assisted Reproductive Technology(ART) outcome of patients with at least two and maximum of five embryos, A randomized clinical trial
Public title
Sequential transfer of a day 2/3 embryo and day 5/6 embryo compared to one step two day 2/3 embryo transfer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women candidate for oocyte puncture and fresh embryo transfer with minimum of two and maximum of five embryos
Exclusion criteria:
Women with structural and anatomical uterine abnormalities
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
140
Actual sample size reached:
140
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomization list of samples in groups will be generated using Random Allocation1 software. Then, according to the order of patient's referral and taking into account the criteria for entering the study, according to the patient's entry number from the list, the study group is announced to the researcher by the statistical consultant, and on each sample according to the study group , the intervention is done or they are placed in the control 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 Research and Clinical Center for infertility, Shahid Sadoughi University
Street address
Bouali Ave, Safaeiyeh
City
Yazd
Province
Yazd
Postal code
8916877391
Approval date
2023-08-06, 1402/05/15
Ethics committee reference number
IR.SSU.RSI.REC.1402.008
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Clinical pregnancy
Timepoint
4 weeks after embryo transfer
Method of measurement
Observation of fetal heart activity by transvaginal ultrasonography
Secondary outcomes
1
Description
Chemical pregnancy
Timepoint
Two weeks after embryo transfer
Method of measurement
Through blood sample Beta Hcg
2
Description
Early misscariage rate
Timepoint
Ten weeks after embryo transfer
Method of measurement
Absence of fetal heart activity in ultrasound
3
Description
Ectopic pregnancy
Timepoint
After positive result for chemical pregnancy
Method of measurement
No rise in serum Beta Hcg level and not visualizing intra uterine gestetianal sac in Trans Vaginal Ultrasound
Intervention groups
1
Description
Intervention group: Infertile women candidate for IVF/ICSI, if they are eligible for fresh embryo transfer, and the number of their embryos is at minimum of two and maximum of five, after obtaining a written consent, they will undergo sequential embryo transfer. In this way, in the first step, a cleavage stage embryo will be transferd. After two to three days, transfer of the second embryo as a blastocyst will be done .
Category
Treatment - Other
2
Description
Control group: Infertile women candidate for IVF/ICSI, if they are eligible for fresh embryo transfer, and the number of their embryos is at minimum of two and maximum of five, will undergo one step embryo transfer. Two cleavage stage embryo will be transfer for them.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Research and Clinical Center for Infertility
Full name of responsible person
Nahid Homayoon
Street address
Safaeiyeh, Bouali Ave
City
Yazd
Province
Yazd
Postal code
8916977443
Phone
+98 35 3824 8122
Email
Nahid.homayoon@hotmail.com
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
Maryam Eftekhar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Safaeiyeh, Bouali Ave
City
Yazd
Province
Yazd
Postal code
8916977443
Phone
+98 35 1824 7085
Email
eftekharmaryam@yahoo.com
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
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Safaeiyeh, Bouali Ave
City
Yazd
Province
Yazd
Postal code
8916977443
Phone
+98 35 3824 7085
Email
eftekharmaryam@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maryam Eftekhar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Safaeiyeh, Bouali Ave
City
Yazd
Province
Yazd
Postal code
8916977443
Phone
+98 35 1824 7085
Email
eftekharmaryam@yahoo.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
Researchers working in academic centers
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
Submit your request by sending an email. Nahid.homayoon@hotmail.com
What processes are involved for a request to access data/document
By reviewing the researcher's request and providing sufficient documentation of their research and the reason for using the data, it can be provided within a week.