NCT02642601

Brief Summary

the aim of the study is to assess the role of indomethacin in cases of difficult embryo transfer in intracytoplasmic sperm injection cycles.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

December 24, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 30, 2015

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

December 30, 2015

Status Verified

December 1, 2015

Enrollment Period

1.8 years

First QC Date

December 24, 2015

Last Update Submit

December 24, 2015

Conditions

Difficult Embryo Transfer

Keywords

indomethacin, ICSI, difficult embryo transfer

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy rate

    +ve pregnancy test+ gestational sac with fetal pulsation by ultrasound

    2 weeks after +ve pregnancy test

Secondary Outcomes (1)

  • Implantation rate

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

Other Outcomes (1)

  • ongoing pregnancy rate

    after 12 weeks gestation

Study Arms (2)

indomethacin

EXPERIMENTAL

one dose of indomethacin 100 mg rectal suppository;will be adminstrated1-2 hours before embryo transfer

Drug: Indomethacin(KAHIRA PHARMA&CHEM,IND,CO.CAIRO-EGYPT)

no medication

NO INTERVENTION

no indomethacine before embryo transfer

Interventions

Indomethacin(KAHIRA PHARMA&CHEM,IND,CO.CAIRO-EGYPT)DRUG

one dose of indomethacin 100 mg rectal suppository 1- 2 hours before embryo transfer

Also known as: indocid
indomethacin

Eligibility Criteria

Age20 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Infertile patients undergoing ICSI cycle with difficult mock transfer done on day of day of ovum pick up

You may not qualify if:

  • repeated ICSI failure
  • Easy mock embryo transfer on day of ovum pick up
  • Early follicular FSH \>10 IU/l
  • Past history of allergy to NSAID.
  • Past history of asthma, peptic ulcer disease or inflammatory bowel disease. Endometrial pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

IVF center,Cairo university hospital,Egypt

Cairo, Egypt

RECRUITING

Kamal Shoeir private IVF center,Cairo,Egypt

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Indomethacin

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Mona M Shaban, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mona M Shaban, MD

CONTACT

+201001078586drmonashaban@gmail.com

Sherin H Gad Allah, MD

CONTACT

+201097665573sherinehosny@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 24, 2015

First Posted

December 30, 2015

Study Start

March 1, 2014

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

December 30, 2015

Record last verified: 2015-12

Locations

EG(2)