Indomethacin Prior to Difficult Embryo Transfer is it a Solution?

NCT03533803 | Completed Phase 3

• 1 other identifier: 12018
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Implantation rate

  the number of total gestational sacs divided by the total number of embryos transferred.

  6 weeks

Secondary Outcomes (2)

• Clinical pregnancy rate

  6 weeks

• Ongoing pregnancy rate

  12 weeks

Study Arms (2)

Group A (Indomethacin)

ACTIVE COMPARATOR

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; Procedure: IVF/ICSI

Group B (Control)

PLACEBO COMPARATOR

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

Interventions

Indomethacin 100Mg Suppository 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.

Also known as: Indomethacin

Group A (Indomethacin)

IVF/ICSI 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 A (Indomethacin); Group B (Control)

Eligibility Criteria

• Age: 20 Years - 38 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Repeated IVF failure.
• Past history of allergy to NSAID, bronchial asthma , peptic ulcer or inflammatory bowel disease.
• Easy mock embryo transfer.

Sponsors & Collaborators

• Cairo University: lead
• Nile Ivf Center, Cairo, Egypt: collaborator

Study Sites (1)

Nile IVF center

Giza, 12411, Egypt

Location

MeSH Terms

Interventions

Indomethacin; Suppositories

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Sarwat Ahawany, MD

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynaecology

Study Record Dates

• First Submitted: May 12, 2018
• First Posted: May 23, 2018
• Study Start: June 2, 2018
• Primary Completion: December 2, 2018
• Study Completion: December 2, 2018
• Last Updated: December 14, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)