CClinicalTrials.gg
Status unknownNCT02642601Updated Dec 30, 2015

Role of Indomethacin in Difficult Embryo Transfer.

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 sponsor has not verified this record recently (last verified Dec 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 38 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Difficult Embryo Transfer

Keywords

  • indomethacin, ICSI, difficult embryo transfer
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
20 Years to 38 Years
Sexes eligible
Female
Accepts 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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    indomethacin

    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 intervention
    no medication

    no indomethacine before embryo transfer

Interventions

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

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

    Also known as: indocid

06

What researchers measure

Primary outcomes

  1. clinical pregnancy rate

    +ve pregnancy test+ gestational sac with fetal pulsation by ultrasound

    Time frame: 2 weeks after +ve pregnancy test

Secondary outcomes

  1. 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.

Other outcomes

  1. ongoing pregnancy rate

    pregnancy exceeding 12 weeks gestation

    Time frame: after 12 weeks gestation

07

Study locations

2 of 2 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02642601
Lead sponsor
Cairo University
Responsible party
Mona M Shaban (Dr, Cairo University) — Principal investigator
First posted
Dec 30, 2015
Start date
Mar 2014
Primary completion
Dec 2015 (estimated)
Completion
Jan 2016 (estimated)
Last update
Dec 30, 2015

Study contacts

Mona M Shaban, MD
Contact
drmonashaban@gmail.com
+201001078586
Sherin H Gad Allah, MD
Contact
sherinehosny@gmail.com
+201097665573
Mona M Shaban, MD
principal investigator · Cairo University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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