36 Versus 42 Hour Time Interval From Ovulation to Intrauterine Insemination

August 25, 2019 updated by: HaEmek Medical Center, Israel

36 Versus 42 Hour Time Interval From Ovulation Induction to Intrauterine Insemination in Stimulated Cycles With GnRH Antagonists

The purpose of this study is to prove that a higher clinical pregnancy rate can be achieved with a 42 to 44 hour time interval between ovulation trigger and intrauterine insemination than a 36 to 38 hour time interval in stimulated cycles utilizing gonadotropins and GnRH antagonists.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

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

  • Israel
      • Afula, Israel
        • Emek Medical Center

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

17 years to 44 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Patients who can be monitored for follicle growth and hormone measurements on the day of ovulation trigger, or one day before.
  2. Patients who have no more than 4 follicles of 14 mm or more
  3. Patients who have no more than 6 follicles of 10 mm or more

Exclusion Criteria:

  1. Patients who cannot give informed consent to language or comprehension barriers
  2. Patients who are deemed to be at high risk for high order multiple gestations
  3. Patients who cannot be monitored on the day of hCG administration or one day before

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 36 hours
Intrauterine insemination 36 hours after ovulation induction
Procedure: Intrauterine Insemination 36 hours
Intrauterine insemination 36 hours after ovulation induction
Active Comparator: 42 hours
Intrauterine insemination 42 hours after ovulation induction
Procedure: Intrauterine Insemination 42 hours
Intrauterine insemination 42 hours after ovulation induction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy rate
Time Frame: 4 weeks following insemination
4 weeks following insemination

Collaborators and Investigators

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

Sponsor

HaEmek Medical Center, Israel

Investigators

  • Principal Investigator: Amir Weiss, MD, HaEmek Medical Center, Afula, Israel

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

January 1, 2015

Primary Completion (Actual)

April 29, 2018

Study Completion (Actual)

April 29, 2018

Study Registration Dates

First Submitted

July 30, 2014

First Submitted That Met QC Criteria

August 6, 2014

First Posted (Estimate)

August 7, 2014

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 25, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0038-14-EMC

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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