Indomethacin Prior to Difficult Embryo Transfer is it a Solution?

NCT ID: NCT03533803

Last Updated: 2018-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-02
• Study Completion Date: 2018-12-02

Brief 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

Conditions

Difficult Embryo Transfer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group A (Indomethacin)

All patient had long stimulation protocol and IVF/ICSI. After mock embryo transfer women with any degree of difficulty will receive Indomethacin 100Mg Suppository 1-2 hours before embryo transfer.

Group Type: ACTIVE_COMPARATOR

Indomethacin 100Mg Suppository

Intervention Type: DRUG

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.

IVF/ICSI

Intervention Type: PROCEDURE

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.

Group B (Control)

All patient had long stimulation protocol and IVF/ICSI. After mock embryo transfer women with any degree of difficulty will not receive any medications before embryo transfer.

Group Type: PLACEBO_COMPARATOR

IVF/ICSI

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

Other Intervention Names

Indomethacin

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Nile Ivf Center, Cairo, Egypt

OTHER

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Yasmin Ahmed Bassiouny

Assistant Professor of Obstetrics and Gynaecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarwat Ahawany, MD

Role: STUDY_CHAIR

Cairo University

Locations

Nile IVF center

Giza, , Egypt

Countries

Egypt

Other Identifiers

12018

Identifier Type: -

Identifier Source: org_study_id