Indomethacin Prior to Difficult Embryo Transfer is it a Solution?

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

Study Overview

• Status: Completed
• Conditions: Difficult Embryo Transfer
• Intervention / Treatment: Drug: Indomethacin 100Mg Suppository; Procedure: IVF/ICSI

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12411
    • Nile IVF center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 34 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.; Other Names: Indomethacin; 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.
Placebo Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implantation rate	the number of total gestational sacs divided by the total number of embryos transferred.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical pregnancy rate	Presence of fetal pulsations after 2 weeks from the positive pregnancy test.	6 weeks
Ongoing pregnancy rate	Pregnancies continuing beyond 12 weeks	12 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Nile Ivf Center, Cairo, Egypt
• Investigators: Study Chair: Sarwat Ahawany, MD, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2018
• Primary Completion (Actual): December 2, 2018
• Study Completion (Actual): December 2, 2018

Study Registration Dates

• First Submitted: May 12, 2018
• First Submitted That Met QC Criteria: May 12, 2018
• First Posted (Actual): May 23, 2018

Study Record Updates

• Last Update Posted (Actual): December 14, 2018
• Last Update Submitted That Met QC Criteria: December 13, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Reproductive Control Agents; Gout Suppressants; Tocolytic Agents; Indomethacin
• Other Study ID Numbers: 12018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No