Back to resultsAzathioprine in Recurrent Implantation Failure
Primary Purpose
Recurrent Implantation Failure, In Vitro Fertilization, Intracytoplsmic Sperm Injection
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Azathioprine Pill
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Implantation Failure
Eligibility Criteria
Inclusion Criteria:
- age: 20-39
- previous 3 or more failed ivf
Exclusion Criteria:
- intrauterine anomalies
- chronic systemic illness
- chronic pelvic conditions
- sensitivety to azathioprine
Sites / Locations
- Ain Shams University, Maternity Hospital
- Capital Birth Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Azathioprine
Control
Arm Description
Outcomes
Primary Outcome Measures
Clinical pregnancy rate
Secondary Outcome Measures
Side effects
Full Information
NCT ID
NCT03498703
First Posted
April 7, 2018
Last Updated
July 23, 2019
Sponsor
Ain Shams University
Collaborators
Capital Birth Center
1. Study Identification
Unique Protocol Identification Number
NCT03498703
Brief Title
Azathioprine in Recurrent Implantation Failure
Official Title
Azathioprine in Recurrent Implantation Failure
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
April 25, 2018 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
Collaborators
Capital Birth Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Azathioprine increase pregnancy rate in patients with recurrent implantation failure
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Implantation Failure, In Vitro Fertilization, Intracytoplsmic Sperm Injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Azathioprine
Arm Type
Experimental
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Azathioprine Pill
Intervention Description
Azathioprine increase pregnancy rate in cases with recurrent implantaion failure
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Placebo tablets
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Side effects
Time Frame
2 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age: 20-39
previous 3 or more failed ivf
Exclusion Criteria:
intrauterine anomalies
chronic systemic illness
chronic pelvic conditions
sensitivety to azathioprine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed H Salama
Organizational Affiliation
Capital Birth Center
Official's Role
Study Director
Facility Information:
Facility Name
Ain Shams University, Maternity Hospital
City
Cairo
Country
Egypt
Facility Name
Capital Birth Center
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Azathioprine in Recurrent Implantation Failure
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