Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
100 participants
INTERVENTIONAL
2014-03-31
2016-01-31
Brief Summary
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Detailed Description
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All patients will received long stimulation protocol ;down regulation will be achieved by administration of triptorelin0.1 mg(decapeptyl 0.1 mg, Ferring, Malmo, sweden) S.C daily from day 21 of the cycle preceding the stimulation cycle till the day of hCG administration.,down regulation will be checked day 2 of stimulation cycle by checking serum E2˂50 pg/ml, endometrial thickness ˂ 5mm and quiescent both ovaries.
When down regulation is achieved stimulation is commenced using hmG(Menogon, ferring pharmaceuticals, Germany) 225 IU daily intramuscular injection, Serial trans-vaginal ultrasound to assess follicular growth and serum E2 are done starting on day 6 of the cycle and onward, with adjustments of gonadotropin dose and monitoring frequency based on patient response.
Once 3 or more leading follicles reached≥18mm hCG 10000 IU (Pregnyl; NV Organon) will be administrated IM.
Ovum pick up will be done 34-36 hours following hCG administration with ultrasound guidance under general anesthesia.after that mock embryo transfer will be done using labotec embryo transfer catheter and women in which any degree of difficulty according to Tomas et al. 2002 criteria will be recruited in the study and divided randomly into two groups according to computer generated random cards ;group A (n=100): will receive indomethacin 100 mg rectal supp(KAHIRA PHARMA\&CHEM,IND,CO.CAIRO-EGYPT) 1-2 hours before embryo transfer, group B (n=100) will not receive any medications before embryo transfer.
Embryo transfer of 2 embryos will be done by the same technique in lithotomy position with full bladder under ultrasound guidance 2-3 days after ovum pick up depending on the number and quality of available embryos using labotec catheter (Labotec, Gottingen Germanny).
Luteal phase will be achieved Using progesterone vaginal pessaries (Cyclogest, Alpharma, UK) 400 mg twice daily from the day of egg collection till the day of the pregnancy test and continued till 12 week gestation if pregnancy is documented.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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indomethacin
one dose of indomethacin 100 mg rectal suppository;will be adminstrated1-2 hours before embryo transfer
Indomethacin(KAHIRA PHARMA&CHEM,IND,CO.CAIRO-EGYPT)
one dose of indomethacin 100 mg rectal suppository 1- 2 hours before embryo transfer
no medication
no indomethacine before embryo transfer
No interventions assigned to this group
Interventions
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Indomethacin(KAHIRA PHARMA&CHEM,IND,CO.CAIRO-EGYPT)
one dose of indomethacin 100 mg rectal suppository 1- 2 hours before embryo transfer
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Easy mock embryo transfer on day of ovum pick up
* Early follicular FSH \>10 IU/l
* Past history of allergy to NSAID.
* Past history of asthma, peptic ulcer disease or inflammatory bowel disease. Endometrial pathology
20 Years
38 Years
FEMALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Mona M Shaban
Dr
Principal Investigators
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Mona M Shaban, MD
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Locations
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IVF center,Cairo university hospital,Egypt
Cairo, , Egypt
Kamal Shoeir private IVF center,Cairo,Egypt
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Sherin H Gad Allah, MD
Role: primary
Mona M Shaban, MD
Role: backup
Mona M Shaban, MD
Role: primary
Sherine H Gad Allah, MD
Role: backup
Other Identifiers
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MS62014
Identifier Type: -
Identifier Source: org_study_id