Double and Single Intrauterine Insemination In Controlled Ovarian Stimulation (COH) Cycles With Multifollicular Development

Tracking Information
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; (submitted: October 13, 2009)	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; (submitted: October 13, 2009)	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: 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.
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Infertility
Intervention ICMJE	Procedure: Intrauterine insemination (single) Single IUI after 36-38 hours of HCG Other Name: Group I; Procedure: Double intrauterine insemination Double insemination after 18 and 40 hours of HCG administration. Other Name: Grup II
Study Arms	Sham Comparator: Single IUI Single IUI will be carried on after 36-38 hours of HCG administration Intervention: Procedure: Intrauterine insemination (single); Active Comparator: Double IUI Intervention: Procedure: Double intrauterine insemination
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.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: October 13, 2009)	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: 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
Sex/Gender	Sexes Eligible for Study: Female
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