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

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Intrauterine Insemination
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Infertility, Intra-uterine insemination, ovarian stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • HaEmek Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2

3

Arm Description

IUI 36 hours after ovulation induction

IUI 42 hours after ovulation induction

IUI 48 hours after ovulation induction

Outcomes

Primary Outcome Measures

Achieving pregnancy

Secondary Outcome Measures

Live Birth

Full Information

First Posted
May 7, 2008
Last Updated
June 21, 2015
Sponsor
HaEmek Medical Center, Israel
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1. Study Identification

Unique Protocol Identification Number
NCT00675142
Brief Title
Optimal Timing of Intrauterine Insemination (IUI) When Utilizing Superovulation Combined With GnRH Antagonists
Official Title
A Randomized Open Three Arm Prospective Trial To Determine The Optimal Timing for Intrauterine Insemination After Superovulation With Recombinant Gonadotropins Utilizing GnRH Antagonists
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HaEmek Medical Center, Israel

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Infertility, Intra-uterine insemination, ovarian stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
IUI 36 hours after ovulation induction
Arm Title
2
Arm Type
Experimental
Arm Description
IUI 42 hours after ovulation induction
Arm Title
3
Arm Type
Experimental
Arm Description
IUI 48 hours after ovulation induction
Intervention Type
Procedure
Intervention Name(s)
Intrauterine Insemination
Intervention Description
Changing the time span between ovulation induction and IUI during fertility treatment.
Primary Outcome Measure Information:
Title
Achieving pregnancy
Time Frame
2 weeks after intervention
Secondary Outcome Measure Information:
Title
Live Birth
Time Frame
9 months after interventio

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir Weiss, MD
Organizational Affiliation
haemek medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
HaEmek Medical Center
City
Afula
ZIP/Postal Code
18101
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
15236983
Citation
Guzick DS. For now, one well-timed intrauterine insemination is the way to go. Fertil Steril. 2004 Jul;82(1):30-1; discussion 32-5. doi: 10.1016/j.fertnstert.2004.02.101.
Results Reference
background
PubMed Identifier
9895397
Citation
Guzick DS, Carson SA, Coutifaris C, Overstreet JW, Factor-Litvak P, Steinkampf MP, Hill JA, Mastroianni L, Buster JE, Nakajima ST, Vogel DL, Canfield RE. Efficacy of superovulation and intrauterine insemination in the treatment of infertility. National Cooperative Reproductive Medicine Network. N Engl J Med. 1999 Jan 21;340(3):177-83. doi: 10.1056/NEJM199901213400302.
Results Reference
background
PubMed Identifier
15567879
Citation
Gomez-Palomares JL, Julia B, Acevedo-Martin B, Martinez-Burgos M, Hernandez ER, Ricciarelli E. Timing ovulation for intrauterine insemination with a GnRH antagonist. Hum Reprod. 2005 Feb;20(2):368-72. doi: 10.1093/humrep/deh602. Epub 2004 Nov 26.
Results Reference
background

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

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