Role of Indomethacin in Difficult Embryo Transfer.

Cairo University (CU)

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Difficult Embryo Transfer

Treatments

Drug: Indomethacin(KAHIRA PHARMA&CHEM,IND,CO.CAIRO-EGYPT)

Study type

Interventional

Funder types

Other

Identifiers

NCT02642601

MS62014

Details and patient eligibility

About

the aim of the study is to assess the role of indomethacin in cases of difficult embryo transfer in intracytoplasmic sperm injection cycles.

Full description

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.

Enrollment

100 estimated patients

Sex

Female

Ages

20 to 38 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Infertile patients undergoing ICSI cycle with difficult mock transfer done on day of day of ovum pick up

Exclusion criteria

repeated ICSI failure
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