Indomethacin Prior to Difficult Embryo Transfer is it a Solution?

Phase 3

Completed

• Conditions: Difficult Embryo Transfer
• Interventions: Drug: Indomethacin 100Mg Suppository; Procedure: IVF/ICSI

• Registration Number: NCT03533803
• Lead Sponsor: Cairo University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-12
• Study First Submitted QC: 2018-05-12
• Study First Posted: 2018-05-23
• Study Start: 2018-06-02
• Status Verified: 2018-12
• Primary Completion: 2018-12-02
• Study Completion: 2018-12-02
• Last Update Submitted: 2018-12-13
• Last Update Posted: 2018-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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.

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Exclusion Criteria

• Repeated IVF failure.

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

  • Easy mock embryo transfer.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (Indomethacin)	Indomethacin 100Mg Suppository	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 A (Indomethacin)	IVF/ICSI	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 B (Control)	IVF/ICSI	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.

Primary Outcome Measures

Name	Time	Method
Implantation rate	6 weeks	the number of total gestational sacs divided by the total number of embryos transferred.

Secondary Outcome Measures

Name	Time	Method
Ongoing pregnancy rate	12 weeks	Pregnancies continuing beyond 12 weeks
Clinical pregnancy rate	6 weeks	Presence of fetal pulsations after 2 weeks from the positive pregnancy test.

Trial Locations

Locations (1)

Nile IVF center; 🇪🇬 Giza, Egypt