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Trial registered on ANZCTR


Registration number
ACTRN12611000028909
Ethics application status
Approved
Date submitted
30/12/2010
Date registered
10/01/2011
Date last updated
10/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Day 3 versus day 5 embryo transfer in high-responding women undergoing in vitro fertilization: a randomized controlled trial
Scientific title
Day 3 versus day 5 embryo transfer in high-responding women on pregnancy outcomes
Secondary ID [1] 253334 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Day of embryo transfer in women undergoing in vitro fertilization 258873 0
Condition category
Condition code
Reproductive Health and Childbirth 259010 259010 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Embyro transfer on Day 5 post oocyte pick-up and intracytoplasmic sperm injection (i.e. fertilization). Number of embryos will depend on number available on day of transfer but the target for this group is 2 embryos per transfer.
Intervention code [1] 257786 0
Treatment: Other
Comparator / control treatment
Embryo transfer on Day 3 post oocyte pick-up and intracytoplasmic sperm injection (i.e. fertilization). Number of embryos will depend on number available on day of transfer but the target for this group is 3 embryos per transfer.
Control group
Active

Outcomes
Primary outcome [1] 259867 0
Clinical pregnancy rate as assessed using quantitative assessment serum Beta human Chorionic Gonadotropin (B-hCG) levels.
Timepoint [1] 259867 0
2 weeks after embryo transfer
Secondary outcome [1] 268745 0
Live-birth/ ongoing pregnancy rate using follow-up telephone calls until expected time of delivery.
Timepoint [1] 268745 0
>12 weeks after embryo transfer to determine ongoing pregnancies and at 9 months to determine live-births.

Eligibility
Key inclusion criteria
* women’s age <=35 years, with regular cycles (24 to 35 days)
* day 3 follicle stimulating hormone (FSH) <9.5 IU/L
* antral follicle count (AFC) >6
* E2 levels >3,000 pg/mL & endometrial thickness >=8 mm on the day of hCG administration
* at least four grade one embryos (i.e. regular symmetrical blastomeres with no fragmentation) on day 3 after retrieval
Minimum age
18 Years
Maximum age
35 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* women's age >35 years
* <4 grade one embryos on day 3 after retrieval

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be performed using 200 identical dark-sealed envelopes, prepared by one of the investigators and kept in the unit’s pharmacy.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
On day 3, included women will be randomized into two groups using block randomization.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3114 0
Egypt
State/province [1] 3114 0

Funding & Sponsors
Funding source category [1] 258257 0
Self funded/Unfunded
Name [1] 258257 0
Eman Elgindy, MD
Address [1] 258257 0
Department of Obstetrics and Gynecology
Zagazig University School of Medicine
Zagazig
Sharkia Governate
Postal Code: 44519
Country [1] 258257 0
Egypt
Primary sponsor type
Individual
Name
Eman Elgindy, MD
Address
Department of Obstetrics and Gynecology
Zagazig University School of Medicine
Zagazig
Sharkia Governate
Postal Code: 44519
Country
Egypt
Secondary sponsor category [1] 257422 0
None
Name [1] 257422 0
Address [1] 257422 0
Country [1] 257422 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260232 0
Ethical Committee for Research, Al-Banoon Fertility Center
Ethics committee address [1] 260232 0
Al-Banoon Fertility Center
7 El Reyad St.
Zagazig
Sharkia Governate
Postal Code: NA
Ethics committee country [1] 260232 0
Egypt
Date submitted for ethics approval [1] 260232 0
Approval date [1] 260232 0
01/08/2008
Ethics approval number [1] 260232 0
NA

Summary
Brief summary
The objective of this trial is to test the hypothesis that delaying embryo transfer to blastocyst stage may increase the probability of pregnancy in high responders undergoing their first ICSI cycles using the long agonist protocol.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32044 0
Address 32044 0
Country 32044 0
Phone 32044 0
Fax 32044 0
Email 32044 0
Contact person for public queries
Name 15291 0
Eman Elgindy, MD
Address 15291 0
Department of Obstetrics and Gynecology
Zagazig University School of Medicine
Zagazig
Sharkia Governate
Postal Code: 44519
Country 15291 0
Egypt
Phone 15291 0
+20-2-2692-2453
Fax 15291 0
+20-12-749-1143
Email 15291 0
eaelgindy@zu.edu.eg
Contact person for scientific queries
Name 6219 0
Eman Elgindy, MD
Address 6219 0
Department of Obstetrics and Gynecology
Zagazig University School of Medicine
Zagazig
Sharkia Governate
Postal Code: 44519
Country 6219 0
Egypt
Phone 6219 0
+20-2-2692-2453
Fax 6219 0
+20-12-749-1143
Email 6219 0
eaelgindy@zu.edu.eg

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary