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IUI vs. IVF/ICSI in Women Aged 38-42 Years: a Prospective Randomized Controlled Trial.

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ClinicalTrials.gov Identifier: NCT01992731
Recruitment Status : Unknown
Verified March 2015 by Michael De Brucker, Universitair Ziekenhuis Brussel.
Recruitment status was:  Recruiting
First Posted : November 25, 2013
Last Update Posted : March 27, 2015
Sponsor:
Information provided by (Responsible Party):
Michael De Brucker, Universitair Ziekenhuis Brussel

Brief Summary:
Prospective randomised controlled trial: 3 IUI cycles versus 1 IVF/ICSI cycle in women aged 38-42 years.

Condition or disease Intervention/treatment Phase
Infertility Other: Drug: Follitropine Bèta Phase 4

Detailed Description:

Study design:

Prospective randomised controlled trial: 3 IUI cycles versus 1 IVF/ICSI cycle in women aged 38-42 years. .

Group 1: 3 consecutive gonadotrophin stimulated IUI cycles (Follitropine Bèta, Puregon, MSD).

vs. Group 2: 1 IVF/ ICSI cycle - Recombinant FSH (Follitropine Bèta, Puregon, MSD) - Antagonist protocol.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: IUI vs. IVF/ICSI in Women Aged 38-42 Years: a Prospective Randomized Controlled Trial
Study Start Date : December 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : March 2017

Arm Intervention/treatment
Active Comparator: IUI group

Group 1: Patients undergo a standard treatment with 3 consecutive gonadotrophin stimulated IUI cycles Intervention: treatment choice and drug:(Follitropine Bèta, Puregon, MSD).

vs.

Other: Drug: Follitropine Bèta
Active Comparator: IVF/ICSI arm

Group 2: 1 Patients start immediately with IVF/ICSI instead of IUI. A standard antagonist protocol with treatment with a recombinant FSH (Follitropine Bèta, Puregon, MSD) is used.

Intervention: treatment choice and drug: recombinant FSH (Follitropine Bèta, Puregon,

Other: Drug: Follitropine Bèta



Primary Outcome Measures :
  1. Ongoing pregnancy rate [ Time Frame: 12 weeks ]

    Study design:

    Prospective randomised controlled trial: 3 IUI cycles versus 1 IVF/ICSI cycle in women aged 38-42 years.

    Group 1: 3 consecutive gonadotrophin stimulated IUI cycles (Follitropine Bèta, Puregon, MSD).

    vs. Group 2: 1 IVF/ ICSI cycle - Recombinant FSH (Follitropine Bèta, Puregon, MSD) - Antagonist protocol.

    Primary endpoint:

    Comparison of the cumulative ongoing pregnancy rates after 3 IUI cycles versus 1 IVF/ICSI cycle.




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Ages Eligible for Study:   38 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Women aged between 38 and 42 years. Sperm: use of donor sperm or husband sperm reaching WHO criteria 2010.

Exclusion Criteria:

  • Tubal infertility (even one tube).
  • Major uterine or ovarian abnormalities
  • Metabolic abnormalities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992731


Locations
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Belgium
UniversitairZB Recruiting
Jette, Belgium
Contact: Michael De Brucker, MD    024776699    mdebruck@vub.ac.be   
Contact    003224776699      
Sub-Investigator: Michaël De Brucker, MD         
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
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Principal Investigator: Michael De Brucker, MD Universitair Ziekenhuis Brussel
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Responsible Party: Michael De Brucker, MD, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT01992731    
Other Study ID Numbers: IUI versus IVF/ICSI
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: March 27, 2015
Last Verified: March 2015
Keywords provided by Michael De Brucker, Universitair Ziekenhuis Brussel:
Age (38-42 years)
pregnancy rates
3 IUI cycles
1 IVF/ICSI cycle
Additional relevant MeSH terms:
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Infertility