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Timing of Intrauterine Insemination (IUI) 24 or 48 Hours After Spontaneous Luteinizing Hormone (LH) Peak

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ClinicalTrials.gov Identifier: NCT01622023
Recruitment Status : Completed
First Posted : June 18, 2012
Last Update Posted : July 22, 2013
Sponsor:
Information provided by (Responsible Party):
Christophe Blockeel, Universitair Ziekenhuis Brussel

Study Description
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Brief Summary:
The aim of the present study is to prospectively evaluate whether performing an intra-uterine insemination 24 hours after the spontaneous LH peak may result in significantly higher ongoing pregnancy rates compared to 48 hours.

Condition or disease Intervention/treatment Phase
Pregnancy Procedure: intra-uterine insemination Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 435 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Timing of IUI 24 or 48 Hours After Spontaneous LH Peak: a Randomised Controlled Trial
Study Start Date : October 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: Study group
intrauterine insemination after 24 hours
 Procedure: intra-uterine insemination
Artificial insemination is the process by which sperm is placed into the reproductive tract of a female for the purpose of impregnating the female by using means other than sexual intercourse or natural insemination.
Other Name: no other interventions
Active Comparator: Control group
intrauterine insemination after 48 hours
 Procedure: intra-uterine insemination
Artificial insemination is the process by which sperm is placed into the reproductive tract of a female for the purpose of impregnating the female by using means other than sexual intercourse or natural insemination.
Other Name: no other interventions


Outcome Measures
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Primary Outcome Measures :
  1. pregnancy rate [ Time Frame: end of 2013 (up to 2 years) ]

Secondary Outcome Measures :
  1. live birth rate [ Time Frame: end of 2013 (up to 2 years) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • below 39 years of age on the day of LH peak
  • donor semen
  • natural cycle (without CC)
  • cycle with less than 3 follicles reaching 15 mm of diameter or more.
  • with basal hormonal values of progesterone ( < 1,2 ng/dl)

Exclusion Criteria:

The patients excluded are women

  • who underwent more than 6 intrauterine inseminations,
  • with tubal infertility
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01622023


Locations
Belgium
Christophe Blockeel
Brussel, Belgium, 1090
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Christophe Blockeel, MD, PhD, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT01622023     History of Changes
Other Study ID Numbers: 1/2012
First Posted: June 18, 2012    Key Record Dates
Last Update Posted: July 22, 2013
Last Verified: July 2013

Keywords provided by Christophe Blockeel, Universitair Ziekenhuis Brussel:
insemination
donor sperm
natural cycle