HCG Versus Spontaneous LH in Intrauterine Insemination (IUI ) Cycles

This study has been completed.

Sponsor:

Information provided by:

Universitair Ziekenhuis Brussel

ClinicalTrials.gov Identifier:

NCT01414673

First received: August 5, 2011

Last updated: August 10, 2011

Last verified: August 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	August 5, 2011
Last Updated Date	August 10, 2011
Start Date ^ICMJE	April 2009
Primary Completion Date	July 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 10, 2011)	ongoing pregnancy rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01414673 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	HCG Versus Spontaneous LH in Intrauterine Insemination (IUI ) Cycles
Official Title ^ICMJE	Spontaneous Triggering of Ovulation vs. Administration of Human Chorionic Gonadotropin in Patients Undergoing Intrauterine Insemination: a Prospective Randomized Study.
Brief Summary	We recently reported the superiority of the natural cycle to a natural cycle controlled by the administration of human chorionic gonadotropin (hCG) for planning the frozen-thawed embryo transfer cycles, demonstrating a probable negative impact of exogenous hCG on endometrial receptivity.Based on the above findings we conducted the first prospective study that assesses whether there is a difference in pregnancy rate after intrauterine insemination (IUI) in a natural cycle with spontaneous luteinizing hormone (LH) rise compared to natural cycles controlled by hCG for final ovulation.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 0
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Spontaneous Triggering of Ovulation vs. Administration of Human Chorionic Gonadotropin in Patients Undergoing IUI
Intervention ^ICMJE	Drug: HCG 5000 IU
Study Arm (s)	spontaneous LH Intervention: Drug: HCG Experimental: HCG Intervention: Drug: HCG
Publications *	Kosmas IP, Tatsioni A, Fatemi HM, Kolibianakis EM, Tournaye H, Devroey P. Human chorionic gonadotropin administration vs. luteinizing monitoring for intrauterine insemination timing, after administration of clomiphene citrate: a meta-analysis. Fertil Steril. 2007 Mar;87(3):607-12. Epub 2006 Dec 14.
* 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	300
Completion Date	August 2011
Primary Completion Date	July 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: age ≤ 36 years, regular menstrual cycles, body mass index (BMI) between 18 and 29 kg/m², basal levels of FSH (≤ 12 IU/l), estradiol (≤ 80 pg/ml) and progesterone (≤ 1.6ng/ml) on day one of the cycle, normal hysterosalpingography (maximum 3 months prior starting the cycle). The use of donor sperm was also accepted as inclusion criteria. Exclusion Criteria: PCOS endometriosis
Gender	Female
Ages	18 Years to 36 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Belgium

Administrative Information
NCT Number ^ICMJE	NCT01414673
Other Study ID Numbers ^ICMJE	WAS11
Has Data Monitoring Committee	Yes
Responsible Party	Devroey Paul, CRG
Study Sponsor ^ICMJE	Universitair Ziekenhuis Brussel
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Universitair Ziekenhuis Brussel
Verification Date	August 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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