Difficult Embryo Transfer Clinical Trial
Official title:
Role of Indomethacin in Cases of Difficult Embryo Transfer in Intra Cytoplasmic Sperm Injection Cycles
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03533803 -
Indomethacin Prior to Difficult Embryo Transfer is it a Solution?
|
Phase 3 |