Double and Single Intrauterine Insemination In Controlled Ovarian Stimulation (COH) Cycles With Multifollicular Development
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ClinicalTrials.gov Identifier: NCT00993902 |
Recruitment Status
:
Completed
First Posted
: October 14, 2009
Last Update Posted
: October 14, 2009
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Sponsor:
Baskent University
Information provided by:
Baskent University
Tracking Information | |||
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First Submitted Date ICMJE | July 22, 2009 | ||
First Posted Date ICMJE | October 14, 2009 | ||
Last Update Posted Date | October 14, 2009 | ||
Study Start Date ICMJE | May 2008 | ||
Actual Primary Completion Date | May 2009 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
ongoing pregnancy rates [ Time Frame: pregnancy >12 weeks of gestation ] | ||
Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | No Changes Posted | ||
Current Secondary Outcome Measures ICMJE |
The effects of different coh regimens on outcomes [ Time Frame: 14 days after IUI procedure ] | ||
Original Secondary Outcome Measures ICMJE | Same as current | ||
Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Double and Single Intrauterine Insemination In Controlled Ovarian Stimulation (COH) Cycles With Multifollicular Development | ||
Official Title ICMJE | Not Provided | ||
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:
Primary outcome: Ongoing pregnancy rates Secondary outcomes: The effects of different coh regimens (CC,FSH,CC+FSH)on the outcomes. |
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Study Type ICMJE | Interventional | ||
Study Phase | Phase 4 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Infertility | ||
Intervention ICMJE |
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Study Arms |
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Publications * | 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. | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
228 | ||
Original Actual Enrollment ICMJE | Same as current | ||
Actual Study Completion Date | July 2009 | ||
Actual Primary Completion Date | May 2009 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 20 Years to 37 Years (Adult) | ||
Accepts Healthy Volunteers | Yes | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Turkey | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00993902 | ||
Other Study ID Numbers ICMJE | BU1 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Associated Prof.Tayfun Bagis, MD | ||
Study Sponsor ICMJE | Baskent University | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Baskent University | ||
Verification Date | October 2009 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |