Back to results36 Versus 42 Hour Time Interval From Ovulation to Intrauterine Insemination
Primary Purpose
Infertility
Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Intrauterine Insemination 36 hours
Intrauterine Insemination 42 hours
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- Patients who can be monitored for follicle growth and hormone measurements on the day of ovulation trigger, or one day before.
- Patients who have no more than 4 follicles of 14 mm or more
- Patients who have no more than 6 follicles of 10 mm or more
Exclusion Criteria:
- Patients who cannot give informed consent to language or comprehension barriers
- Patients who are deemed to be at high risk for high order multiple gestations
- Patients who cannot be monitored on the day of hCG administration or one day before
Sites / Locations
- Emek Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
36 hours
42 hours
Arm Description
Intrauterine insemination 36 hours after ovulation induction
Intrauterine insemination 42 hours after ovulation induction
Outcomes
Primary Outcome Measures
Clinical pregnancy rate
Secondary Outcome Measures
Full Information
NCT ID
NCT02210611
First Posted
July 30, 2014
Last Updated
August 25, 2019
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT02210611
Brief Title
36 Versus 42 Hour Time Interval From Ovulation to Intrauterine Insemination
Official Title
36 Versus 42 Hour Time Interval From Ovulation Induction to Intrauterine Insemination in Stimulated Cycles With GnRH Antagonists
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
Recruition too slow
Study Start Date
January 2015 (undefined)
Primary Completion Date
April 29, 2018 (Actual)
Study Completion Date
April 29, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to prove that a higher clinical pregnancy rate can be achieved with a 42 to 44 hour time interval between ovulation trigger and intrauterine insemination than a 36 to 38 hour time interval in stimulated cycles utilizing gonadotropins and GnRH antagonists.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
36 hours
Arm Type
Active Comparator
Arm Description
Intrauterine insemination 36 hours after ovulation induction
Arm Title
42 hours
Arm Type
Active Comparator
Arm Description
Intrauterine insemination 42 hours after ovulation induction
Intervention Type
Procedure
Intervention Name(s)
Intrauterine Insemination 36 hours
Intervention Description
Intrauterine insemination 36 hours after ovulation induction
Intervention Type
Procedure
Intervention Name(s)
Intrauterine Insemination 42 hours
Intervention Description
Intrauterine insemination 42 hours after ovulation induction
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Time Frame
4 weeks following insemination
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who can be monitored for follicle growth and hormone measurements on the day of ovulation trigger, or one day before.
Patients who have no more than 4 follicles of 14 mm or more
Patients who have no more than 6 follicles of 10 mm or more
Exclusion Criteria:
Patients who cannot give informed consent to language or comprehension barriers
Patients who are deemed to be at high risk for high order multiple gestations
Patients who cannot be monitored on the day of hCG administration or one day before
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir Weiss, MD
Organizational Affiliation
Haemek Medical Center, Afula, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emek Medical Center
City
Afula
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
36 Versus 42 Hour Time Interval From Ovulation to Intrauterine Insemination
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