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Trial registered on ANZCTR


Registration number
ACTRN12613001316796
Ethics application status
Approved
Date submitted
26/10/2013
Date registered
26/11/2013
Date last updated
26/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Endometrial preparation for cryo embryo transfer: effect of Gonadotropin Releasing Hormone Agonists (GnRHa) coupled with oestrogen and progesterone on hormonal profile and pregnancy rate
Scientific title
The effect of endometrial preparation by pretreatment with Gonadotrophin-releasing hormone agonist (GnRha), oestrogen and progesterone, compared to endometrial preparation by oestrogen and progesterone only, on clinical pregnancy rate in infertile couples undergoing cryo embryo transfer as treatment for infertility
Secondary ID [1] 283460 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility 290379 0
Condition category
Condition code
Reproductive Health and Childbirth 290769 290769 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure

Group B (intervention group):

Patient will be treated with the GnRh-analouge, triptorelin 0.1mg/day subcutaneously beginning in the mid luteal phase of the previous menstrual cycle and continuing till the date of embryo transfer. Full pituitary desensitization will be ensured by measuring serum estradiol on the first day of the menstrual cycle and should be less than 50 picogram /dl

Endometrial preparation will begin from third day of menstruation by oral Estradiol valerate 8mg/day till endomtrium exceeding 8.5mm, then progesterone administration rectal suppository 400mg Am and intramuscular 100mg Pm.
Intervention code [1] 288173 0
Treatment: Drugs
Comparator / control treatment
Group A (control group): Endometrial preparation will begin from third day of menstruation by oral Estradiol valerate 8mg/day till endomtrium exceeding 8.5mm, then progesterone administration rectal suppository 400mg Am and intramuscular 100mg Pm .
Control group
Active

Outcomes
Primary outcome [1] 290765 0
clinical pregnancy rate by
1. serum human chorionic gonadotropin (hCG) assay 14 days after embryo transfer
2. Vaginal ultrasound 2 weeks after a positive pregnancy test to detect cardiac pulsation
Timepoint [1] 290765 0
The primary time point (clinical pregnancy rate) is assessed 2 weeks after the frozen embryo transfer. The whole study will take a one year duration
Secondary outcome [1] 305236 0
none
Timepoint [1] 305236 0
none

Eligibility
Key inclusion criteria
1. Age: 35 years old or less.
2. Infertility: primary or secondary
3. Embryos: were frozen on day five.
4. Cryopreservation: closed method vitrification
5. Laser assisted hatching prior to embryo transfer.
Minimum age
18 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age above 35 years old.
2. Abnormal uterine factor diagnosed by Vaginal sonography, Hysteroscopy or Hysterosalpingography

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2013
Actual
Date of last participant enrolment
Anticipated
1/01/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment outside Australia
Country [1] 5538 0
Egypt
State/province [1] 5538 0
Alexandria

Funding & Sponsors
Funding source category [1] 288171 0
Hospital
Name [1] 288171 0
Elshatby University Maternity Hospital
Department of Obstetrics and Gynecology
Country [1] 288171 0
Egypt
Primary sponsor type
Hospital
Name
Elshatby University Maternity Hospital Department of Obstetrics and Gynecology
Address
Elshatby University Maternity Hospital
Department of Obstetrics and Gynecology
Elshatby
PO Box; 23615
Alexandria
Egypt
Country
Egypt
Secondary sponsor category [1] 286894 0
None
Name [1] 286894 0
Address [1] 286894 0
Country [1] 286894 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43866 0
A/Prof Yasser Ibrahim Orief
Address 43866 0
Dr Yasser orief
El-Mosheer Ahmed Ismaiel St.,
Panorama Elshark Building
Sidi Gaber Elshiekh tram station above HSBC bank
PO box: 21615
Alexandria
Egypt.
Country 43866 0
Egypt
Phone 43866 0
+20 100 8233 121
Fax 43866 0
+20 3 544 22 64 (extension 102)
Email 43866 0
yaserorief@yahoo.com
Contact person for public queries
Name 43867 0
Yasser Ibrahim Orief
Address 43867 0
Dr Yasser orief
El-Mosheer Ahmed Ismaiel St.,
Panorama Elshark Building
Sidi Gaber Elshiekh tram station above HSBC bank
PO box: 21615
Alexandria
Egypt.
Country 43867 0
Egypt
Phone 43867 0
+20 100 8233 121
Fax 43867 0
+20 3 544 22 64 (extension 102)
Email 43867 0
yaserorief@yahoo.com
Contact person for scientific queries
Name 43868 0
Yasser Ibrahim Orief
Address 43868 0
Dr Yasser orief
El-Mosheer Ahmed Ismaiel St.,
Panorama Elshark Building
Sidi Gaber Elshiekh tram station above HSBC bank
PO box: 21615
Alexandria
Egypt.
Country 43868 0
Egypt
Phone 43868 0
+20 100 8233 121
Fax 43868 0
+20 3 544 22 64 (extension 102)
Email 43868 0
yaserorief@yahoo.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.