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Role of Indomethacin in Difficult Embryo Transfer.

Role of Indomethacin in Cases of Difficult Embryo Transfer in Intra Cytoplasmic Sperm Injection Cycles

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02642601
Enrollment
100
Registered
2015-12-30
Start date
2014-03-31
Completion date
2016-01-31
Last updated
2015-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Difficult Embryo Transfer

Keywords

indomethacin, ICSI, difficult embryo transfer

Brief summary

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

Detailed 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.

Interventions

DRUGIndomethacin(KAHIRA PHARMA&CHEM,IND,CO.CAIRO-EGYPT)

one dose of indomethacin 100 mg rectal suppository 1- 2 hours before embryo transfer

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 38 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
clinical pregnancy rate2 weeks after +ve pregnancy test+ve pregnancy test+ gestational sac with fetal pulsation by ultrasound

Secondary

MeasureTime frameDescription
Implantation ratethe number of total gestational sacs divided by the total number of embryos transferred.2-4 weeks after positive pregnancy test

Other

MeasureTime frameDescription
ongoing pregnancy rateafter 12 weeks gestationpregnancy exceeding 12 weeks gestation

Countries

Egypt

Contacts

Primary ContactMona M Shaban, MD
drmonashaban@gmail.com+201001078586
Backup ContactSherin H Gad Allah, MD
sherinehosny@gmail.com+201097665573

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026