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

Primary Purpose

Infertility

Status
Unknown status
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Drug: Follitropine Bèta
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Age (38-42 years), pregnancy rates, 3 IUI cycles, 1 IVF/ICSI cycle

Eligibility Criteria

38 Years - 42 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • UniversitairZBRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

IUI group

IVF/ICSI arm

Arm Description

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

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,

Outcomes

Primary Outcome Measures

Ongoing pregnancy rate
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.

Secondary Outcome Measures

Full Information

First Posted
November 12, 2013
Last Updated
March 25, 2015
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT01992731
Brief Title
IUI vs. IVF/ICSI in Women Aged 38-42 Years: a Prospective Randomized Controlled Trial.
Official Title
IUI vs. IVF/ICSI in Women Aged 38-42 Years: a Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Age (38-42 years), pregnancy rates, 3 IUI cycles, 1 IVF/ICSI cycle

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IUI group
Arm Type
Active Comparator
Arm Description
Group 1: Patients undergo a standard treatment with 3 consecutive gonadotrophin stimulated IUI cycles Intervention: treatment choice and drug:(Follitropine Bèta, Puregon, MSD). vs.
Arm Title
IVF/ICSI arm
Arm Type
Active Comparator
Arm Description
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,
Intervention Type
Other
Intervention Name(s)
Drug: Follitropine Bèta
Primary Outcome Measure Information:
Title
Ongoing pregnancy rate
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. Primary endpoint: Comparison of the cumulative ongoing pregnancy rates after 3 IUI cycles versus 1 IVF/ICSI cycle.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
38 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael De Brucker, MD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
UniversitairZB
City
Jette
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael De Brucker, MD
Phone
024776699
Email
mdebruck@vub.ac.be
Phone
003224776699
First Name & Middle Initial & Last Name & Degree
Michaël De Brucker, MD

12. IPD Sharing Statement

Learn more about this trial

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

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