A Phase 2/3 interventional study of Indomethacin(KAHIRA PHARMA&CHEM,IND,CO.CAIRO-EGYPT) in Difficult Embryo Transfer, sponsored by Cairo University. Status unknown at 2 sites in Egypt. Open to female participants aged 20 Years to 38 Years. Per ClinicalTrials.gov, last updated 2015-12-30.
Sponsored by Cairo University · Phase 2/3, Interventional, and Prevention
the aim of the study is to assess the role of indomethacin in cases of difficult embryo transfer in intracytoplasmic sperm injection cycles.
It is a prospective randomized study in which 200 women undergoing ICSI( intracytoplasmic sperm injection) and fulfilling the inclusion criteria(Difficult mock embryo transfer on day of ovum pick up ,Women's age 20-38 yaears,Early follicular FSH ≤10 IU/l ,Tubal, male infertility, unexplained factors of infertility.) will be recruited.
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.
Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
one dose of indomethacin 100 mg rectal suppository;will be adminstrated1-2 hours before embryo transfer
Drug: Indomethacin(KAHIRA PHARMA&CHEM,IND,CO.CAIRO-EGYPT)
no indomethacine before embryo transfer
one dose of indomethacin 100 mg rectal suppository 1- 2 hours before embryo transfer
Also known as: indocid
clinical pregnancy rate
+ve pregnancy test+ gestational sac with fetal pulsation by ultrasound
Time frame: 2 weeks after +ve pregnancy test
Implantation rate
2-4 weeks after positive pregnancy test
Time frame: the number of total gestational sacs divided by the total number of embryos transferred.
ongoing pregnancy rate
pregnancy exceeding 12 weeks gestation
Time frame: after 12 weeks gestation
This study is status unknown, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Cairo University