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

This study is not yet open for participant recruitment.
Verified by HaEmek Medical Center, Israel, May 2008

Sponsored by: HaEmek Medical Center, Israel
Information provided by: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT00675142
  Purpose

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.


Condition Intervention
Infertility
Procedure: Intrauterine Insemination

MedlinePlus related topics:   Infertility   

Drug Information available for:   Gonadorelin    Gonadorelin hydrochloride    LH-RH   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
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

Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • Achieving pregnancy [ Time Frame: 2 weeks after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Live Birth [ Time Frame: 9 months after interventio ] [ Designated as safety issue: No ]

Estimated Enrollment:   100

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

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675142

Contacts
Contact: Amir Weiss, MD     972-649-5565     weiss_am@clalit.org.il    

Locations
Israel
HaEmek Medical Center    
      Afula, Israel, 18101

Sponsors and Collaborators
HaEmek Medical Center, Israel

Investigators
Principal Investigator:     Amir Weiss, MD     HaEmek Medical Center    
  More Information


Publications:

Responsible Party:   HaEmek Medical Center ( Amir Weiss MD )
Study ID Numbers:   5-08EMC.CTIL
First Received:   May 7, 2008
Last Updated:   May 7, 2008
ClinicalTrials.gov Identifier:   NCT00675142
Health Authority:   Israel: Ministry of Health

Keywords provided by HaEmek Medical Center, Israel:
Infertility  
Intra-uterine insemination  
ovarian stimulation  

Study placed in the following topic categories:
Genital Diseases, Female
Infertility
Genital Diseases, Male

ClinicalTrials.gov processed this record on October 23, 2008




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