Double and Single Intrauterine Insemination In Controlled Ovarian Stimulation (COH) Cycles With Multifollicular Development
Primary Purpose
Infertility
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Intrauterine insemination (single)
Double intrauterine insemination
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Double IUI, Intrauterine insemination, Unexplained infertility
Eligibility Criteria
Inclusion Criteria:
- Unexplained and mild male factor infertile patients
- Minimum 2 follicles >16 mm at the day of HCG
- First 3 cycles
Exclusion Criteria:
- Basal FSH >12 mIU/L
- Total antral follicle count<6
- Severe male factor infertility
Sites / Locations
- Baskent University Medical Faculty Obstetric and Gynecelogy Department, Infertility and IVF unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Single IUI
Double IUI
Arm Description
Single IUI will be carried on after 36-38 hours of HCG administration
Outcomes
Primary Outcome Measures
ongoing pregnancy rates
Secondary Outcome Measures
The effects of different coh regimens on outcomes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00993902
Brief Title
Double and Single Intrauterine Insemination In Controlled Ovarian Stimulation (COH) Cycles With Multifollicular Development
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Baskent University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Our hypothesis is double insemination will improve pregnancy rates in coh cycles with more than one dominant follicles (>16mm).
Detailed Description
Metaanalysis for the effects of double IUI demonstrates that effects of this procedure is not different from single IUI. It is known that nearly 25% of coh cycles is evident by monofollicular development.For this reason it is possible that this monofollicular cycles in the studies could decrease the effects of double IUI.
Inclusion criteria:
Patients with unexplained infertility or mild male factor infertility whom admitted to the COH+IUI programme in our infertility unit.
Female age <37 years old.
Baseline FSH <12 mIU/L
Total antral follicle count>6
During the first three cycles of COH+IUI
Minimum 2 follicles >16 mm at the day of HCG.
Primary outcome:
Ongoing pregnancy rates
Secondary outcomes:
The effects of different coh regimens (CC,FSH,CC+FSH)on the outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Double IUI, Intrauterine insemination, Unexplained infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
228 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single IUI
Arm Type
Sham Comparator
Arm Description
Single IUI will be carried on after 36-38 hours of HCG administration
Arm Title
Double IUI
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Intrauterine insemination (single)
Other Intervention Name(s)
Group I
Intervention Description
Single IUI after 36-38 hours of HCG
Intervention Type
Procedure
Intervention Name(s)
Double intrauterine insemination
Other Intervention Name(s)
Grup II
Intervention Description
Double insemination after 18 and 40 hours of HCG administration.
Primary Outcome Measure Information:
Title
ongoing pregnancy rates
Time Frame
pregnancy >12 weeks of gestation
Secondary Outcome Measure Information:
Title
The effects of different coh regimens on outcomes
Time Frame
14 days after IUI procedure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Unexplained and mild male factor infertile patients
Minimum 2 follicles >16 mm at the day of HCG
First 3 cycles
Exclusion Criteria:
Basal FSH >12 mIU/L
Total antral follicle count<6
Severe male factor infertility
Facility Information:
Facility Name
Baskent University Medical Faculty Obstetric and Gynecelogy Department, Infertility and IVF unit
City
Adana
ZIP/Postal Code
01120
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
20457669
Citation
Bagis T, Haydardedeoglu B, Kilicdag EB, Cok T, Simsek E, Parlakgumus AH. Single versus double intrauterine insemination in multi-follicular ovarian hyperstimulation cycles: a randomized trial. Hum Reprod. 2010 Jul;25(7):1684-90. doi: 10.1093/humrep/deq112. Epub 2010 May 10.
Results Reference
derived
Learn more about this trial
Double and Single Intrauterine Insemination In Controlled Ovarian Stimulation (COH) Cycles With Multifollicular Development
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