NCT02329197

Brief Summary

Women with history of previous IVF cycle failure will be subjected to a fresh IVF cycle. At the time they will be undergoing embryo transfer, 50 IU of human chorionic gonadotropins diluted in 0.025ml of tissue culture media will be injected intrauterine by embryo transfer catheter 10 minutes before embryo transfer procedure.

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
380

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

December 31, 2014

Status Verified

December 1, 2014

Enrollment Period

1 year

First QC Date

December 26, 2014

Last Update Submit

December 30, 2014

Conditions

InfertilityInvitro Fertilization

Keywords

InfertilityInvitro fertilization

Outcome Measures

Primary Outcomes (1)

  • Live Birth

    9 months

Study Arms (2)

Group A

EXPERIMENTAL

women undergoing IVF treatment will be subjected for intrauterine injection of 10 IU of human chorionic gonadotropin (HCG) (diluted in 0.025ml of tissue culture), 10 minutes before embryo transfer procedure.

Drug: Human Chorionic Gonadotropin (HCG)

Group B

NO INTERVENTION

women undergoing IVF treatment will embryo transfer procedure performed in the standard way without intrauterine injection of HCG.

Interventions

Human Chorionic Gonadotropin (HCG)DRUG

intrauterine injection of HCG prior to embryo transfer in an IVF cycle

Also known as: u-hCG
Group A

Eligibility Criteria

Age19 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- women with previous IVF failure undergoing fresh IVF cycle

You may not qualify if:

  • women with hydrosalpinges women with intrauterine lesion like submucous fibroid or polyps

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Teaching Hospital

Al Mansurah, 53111, Egypt

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

GonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPlacental HormonesPeptidesAmino Acids, Peptides, and ProteinsPregnancy ProteinsProteins

Study Officials

  • Ahmed Gibreel, MD

    Mansoura University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Gibreel, MD

CONTACT

002/01004045733ahmedfathgi@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 26, 2014

First Posted

December 31, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2015

Study Completion

March 1, 2016

Last Updated

December 31, 2014

Record last verified: 2014-12

Locations

EG(1)