Indomethacin Prior to Difficult Embryo Transfer is it a Solution?

Difficult Embryo Transfer Clinical Trial

Official title:

Indomethacin Prior to Difficult Embryo Transfer is it a Solution?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03533803
• Other study ID #: 12018
• Status: Completed
• Phase: Phase 3
• Start date: June 2, 2018
• Est. completion date: December 2, 2018

Study information

• Verified date: December 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

IVF/ICSI patients who had difficult mock embryo transfer on the day of ovum pick up. Will be randomly assigned into two groups; group A will receive 100mg indomethacin rectal suppository 1-2 hours before ET and group B will not receive indomethacin

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2, 2018
• Est. primary completion date: December 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 38 Years

Eligibility

Inclusion Criteria:

• Infertile patients undergoing IVF cycle with difficult mock embryo transfer

• Early follicular FSH level =10 IU/L.

• Tubal, male infertility and unexplained causes of fertility will be recruited.

• Fresh ET.

Exclusion Criteria:

• Repeated IVF failure.

• Past history of allergy to NSAID, bronchial asthma , peptic ulcer or inflammatory bowel disease.

• Easy mock embryo transfer.

Related Conditions & MeSH terms

• Difficult Embryo Transfer

Intervention

Drug:
• Indomethacin 100Mg Suppository
Indomethacin 100Mg Suppository will be given 1 to 2 hours before embryo transfer in cases with difficult mock embryo transfer in the active comparator group.

Procedure:
• IVF/ICSI
patients received induction with the long agonist stimulation protocol. Followed by ovum pickup and embryo transfer. Only those with difficult mock embryo transfer will be recruited in this study.

Locations

Country	Name	City	State
Egypt	Nile IVF center	Giza

Sponsors (2)

Lead Sponsor	Collaborator
Cairo University	Nile Ivf Center, Cairo, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implantation rate	the number of total gestational sacs divided by the total number of embryos transferred.	6 weeks
Secondary	Clinical pregnancy rate	Presence of fetal pulsations after 2 weeks from the positive pregnancy test.	6 weeks
Secondary	Ongoing pregnancy rate	Pregnancies continuing beyond 12 weeks	12 weeks