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

April 17, 2019 updated by: Blockeel Christophe, Universitair Ziekenhuis Brussel

Timing of IUI 24 or 48 Hours After Spontaneous LH Peak: a Randomised Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

435

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussel, Belgium, 1090
        • Christophe Blockeel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • no other interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pregnancy rate
Time Frame: end of 2013 (up to 2 years)
end of 2013 (up to 2 years)

Secondary Outcome Measures

Outcome Measure
Time Frame
live birth rate
Time Frame: end of 2013 (up to 2 years)
end of 2013 (up to 2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

March 27, 2012

First Submitted That Met QC Criteria

June 15, 2012

First Posted (ESTIMATE)

June 18, 2012

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2019

Last Update Submitted That Met QC Criteria

April 17, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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