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

This study has been completed.

Sponsor:

Information provided by:

Baskent University

ClinicalTrials.gov Identifier:

NCT00993902

First received: July 22, 2009

Last updated: October 13, 2009

Last verified: October 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	July 22, 2009
Last Updated Date	October 13, 2009
Start Date ^ICMJE	May 2008
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 ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00993902 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 13, 2009)	The effects of different coh regimens on outcomes [ Time Frame: 14 days after IUI procedure ] [ Designated as safety issue: Yes ]
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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 Arm (s)	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
Enrollment ^ICMJE	228
Completion Date	July 2009
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
Gender	Female
Ages	20 Years to 37 Years
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
Responsible Party	Associated Prof.Tayfun Bagis, MD
Study Sponsor ^ICMJE	Baskent University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Baskent University
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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