Optimal Timing of Intrauterine Insemination (IUI) When Utilizing Superovulation Combined With GnRH Antagonists

June 21, 2015 updated by: Amir Weiss, HaEmek Medical Center, Israel

A Randomized Open Three Arm Prospective Trial To Determine The Optimal Timing for Intrauterine Insemination After Superovulation With Recombinant Gonadotropins Utilizing GnRH Antagonists

The timing of IUI following ovulation induction has been the subject of many studies and a consensus has developed that a single insemination approximately thirty-six hours after ovulation induction is sufficien. The introduction of GnRH antagonists preventing a premature LH surge and early ovulation has added a new dimension to fertility treatment. It allows greater accuracy in predicting the timing of ovulation and has been shown to be at least as effective, if not more effective, as ovarian stimulation without antagonists. We hypothesize that by utilizing GnRH antagonists we can increase pregnancy rates during IUI by timing the IUI as close as possible to the moment of ovulation guaranteeing the highest and freshest concentration of motile spermatozoa in the fallopian tube at the time the oocyte is released from the ovary. We therefore propose a randomized open three arm prospective trial utilizing superovulation with GnRH antagonists whereby the IUI is timed to take place 36, 42 or 48 hours after ovulation induction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

107

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, 18101
        • HaEmek 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women with infertility who are candidates for controlled ovarian stimulation and intrauterine insemination with
  • Ovulatory disorder
  • male factor
  • partial mechanical factor
  • endometriosis
  • unexplained infertility.

Exclusion Criteria:

  • Known allergy to one or more of the utilized drugs
  • Neither fallopian tube is patent
  • Sperm count less than 1 million total motile sperm of normal morphology during at least two investigations
  • Women who are candidates for mono-ovulation.
  • failure to receive consent
  • women with baseline functional cysts (i.e. hormone producing) above 12 mm diameter.

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
Experimental: 1
IUI 36 hours after ovulation induction
Procedure: Intrauterine Insemination
Changing the time span between ovulation induction and IUI during fertility treatment.
Experimental: 2
IUI 42 hours after ovulation induction
Procedure: Intrauterine Insemination
Changing the time span between ovulation induction and IUI during fertility treatment.
Experimental: 3
IUI 48 hours after ovulation induction
Procedure: Intrauterine Insemination
Changing the time span between ovulation induction and IUI during fertility treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Achieving pregnancy
Time Frame: 2 weeks after intervention
2 weeks after intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Live Birth
Time Frame: 9 months after interventio
9 months after interventio

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

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

May 1, 2008

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

May 7, 2008

First Submitted That Met QC Criteria

May 7, 2008

First Posted (Estimate)

May 8, 2008

Study Record Updates

Last Update Posted (Estimate)

June 23, 2015

Last Update Submitted That Met QC Criteria

June 21, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5-08EMC.CTIL

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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