NCT02362061

Brief Summary

100 patients aged 21-40 years old, diagnosed as primary or secondary infertility . These patients are then assigned to receive fertility treatment (ovulation induction, ICSI, intrauterine insemination and IVF). They undergo a 3D vaginal ultrasound before treatment to measure the junctional zone thickness and followed up after treatment to determine the rate of implantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 7, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 12, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

March 24, 2017

Status Verified

March 1, 2017

Enrollment Period

2.8 years

First QC Date

February 7, 2015

Last Update Submit

March 22, 2017

Conditions

Keywords

junctional zoneimplantationthree D ultraosundAssisted Reproductive TechnologyPregnancy

Outcome Measures

Primary Outcomes (1)

  • pregnancy rate

    14 days after evaluation

Secondary Outcomes (1)

  • healthy pregnancy

    6 weeks after pregnancy confirmation by pregnancy test

Study Arms (2)

pregnant

These patients are then assigned to receive fertility treatment (ovulation induction, ICSI, intrauterine insemination and IVF). They undergo a 3D vaginal ultrasound before treatment to measure the junctional zone thickness and followed up after treatment to determine the rate of implantation and they became pregnant

Radiation: 3D ultrasound

Non pregnant

These patients are then assigned to receive fertility treatment (ovulation induction, ICSI, intrauterine insemination and IVF). They undergo a 3D vaginal ultrasound before treatment to measure the junctional zone thickness and followed up after treatment to determine the rate of implantation and they remained non pregnant

Radiation: 3D ultrasound

Interventions

3D ultrasoundRADIATION

ultrasound to measure the thickness of the junctional zone at day 21 of the cycle

Non pregnantpregnant

Eligibility Criteria

Age21 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

100 patients aged 21-40 years old, diagnosed as primary or secondary infertility due to the following causes of infertility; ( Pelvic Inflammatory disease, dysovulation , tubal infertility, unexplained infertility, combined infertility or due to male factor ).

You may qualify if:

  • infertile women

You may not qualify if:

  • congenital uterine anomalies medical disease contraindicating pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, Cairo Governorate, 12151, Egypt

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Ahmed M Maged, MD

    Kasr Alainy medical school

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

February 7, 2015

First Posted

February 12, 2015

Study Start

February 1, 2014

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

March 24, 2017

Record last verified: 2017-03

Locations