Azathioprine in Recurrent Implantation Failure

• Sponsor: Ain Shams University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03498703
• Collaborator: Capital Birth Center (Other)
• Enrollment: 64
• Locations: 2
• Arms: 2
• Actual Duration (Months): 14.2
• Patients Per Site: 32
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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: Apr 25, 2018
• Actual Primary Completion Date: Jul 1, 2019
• Actual Study Completion Date: Jul 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Clinical pregnancy rate [2 weeks]

Secondary Outcome Measures

1. Side effects [2 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 39 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• age: 20-39

• previous 3 or more failed ivf

Exclusion Criteria:

• intrauterine anomalies

• chronic systemic illness

• chronic pelvic conditions

• sensitivety to azathioprine

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University, Maternity Hospital	Cairo		Egypt
2	Capital Birth Center	Cairo		Egypt

Sponsors and Collaborators

• Ain Shams University
• Capital Birth Center

Investigators

• Study Director: Ahmed H Salama, Capital Birth Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Reda, Consultant, Ain Shams University
• ClinicalTrials.gov Identifier: NCT03498703
• Other Study ID Numbers: FW000372
• First Posted: Apr 17, 2018
• Last Update Posted: Jul 24, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Recurrence; Azathioprine

Study Results

No Results Posted as of Jul 24, 2019