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Azathioprine in Recurrent Implantation Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03498703
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
Capital Birth Center
Information provided by (Responsible Party):
Ahmed Reda, Ain Shams University

Brief Summary:
Azathioprine increase pregnancy rate in patients with recurrent implantation failure

Condition or disease Intervention/treatment Phase
Recurrent Implantation Failure In Vitro Fertilization Intracytoplsmic Sperm Injection Drug: Azathioprine Pill Drug: Placebo Oral Tablet Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Azathioprine in Recurrent Implantation Failure
Actual Study Start Date : April 25, 2018
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Azathioprine Drug: Azathioprine Pill
Azathioprine increase pregnancy rate in cases with recurrent implantaion failure

Placebo Comparator: Control Drug: Placebo Oral Tablet
Placebo tablets




Primary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Side effects [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498703


Locations
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Egypt
Ain Shams University, Maternity Hospital
Cairo, Egypt
Capital Birth Center
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
Capital Birth Center
Investigators
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Study Director: Ahmed H Salama Capital Birth Center

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Responsible Party: Ahmed Reda, Consultant, Ain Shams University
ClinicalTrials.gov Identifier: NCT03498703    
Other Study ID Numbers: FW000372
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Azathioprine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents