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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christophe Blockeel, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT01622023
First received: March 27, 2012
Last updated: July 18, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Pregnancy
Procedure: intra-uterine insemination
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Timing of IUI 24 or 48 Hours After Spontaneous LH Peak: a Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Universitair Ziekenhuis Brussel:

Primary Outcome Measures:
  • pregnancy rate [ Time Frame: end of 2013 (up to 2 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • live birth rate [ Time Frame: end of 2013 (up to 2 years) ] [ Designated as safety issue: No ]

Enrollment: 435
Study Start Date: October 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01622023

Locations
Belgium
Christophe Blockeel
Brussel, Belgium, 1090
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
  More Information

No publications provided by Universitair Ziekenhuis Brussel

Additional 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
Study First Received: March 27, 2012
Last Updated: July 18, 2013
Health Authority: Belgium: Ethics Committee

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

ClinicalTrials.gov processed this record on August 01, 2014