NCT03498703

Brief Summary

Azathioprine increase pregnancy rate in patients with recurrent implantation failure

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

April 7, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 17, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

April 25, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

1.2 years

First QC Date

April 7, 2018

Last Update Submit

July 23, 2019

Conditions

Recurrent Implantation FailureIn Vitro FertilizationIntracytoplsmic Sperm Injection

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    2 weeks

Secondary Outcomes (1)

  • Side effects

    2 weeks

Study Arms (2)

Azathioprine

EXPERIMENTAL
Drug: Azathioprine Pill

Control

PLACEBO COMPARATOR
Drug: Placebo Oral Tablet

Interventions

Azathioprine PillDRUG

Azathioprine increase pregnancy rate in cases with recurrent implantaion failure

Azathioprine
Placebo Oral TabletDRUG

Placebo tablets

Control

Eligibility Criteria

Age20 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age: 20-39
  • previous 3 or more failed ivf

You may not qualify if:

  • intrauterine anomalies
  • chronic systemic illness
  • chronic pelvic conditions
  • sensitivety to azathioprine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ain Shams University, Maternity Hospital

Cairo, Egypt

Location

Capital Birth Center

Cairo, Egypt

Location

MeSH Terms

Interventions

Azathioprine

Intervention Hierarchy (Ancestors)

ThionucleosidesSulfur CompoundsOrganic ChemicalsMercaptopurinePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Ahmed H Salama

    Capital Birth Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

April 7, 2018

First Posted

April 17, 2018

Study Start

April 25, 2018

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

July 24, 2019

Record last verified: 2019-07

Locations

EG(2)