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

NCT ID: NCT01992731

Last Updated: 2015-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Drug: Follitropine Bèta

Intervention Type OTHER

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,

Group Type ACTIVE_COMPARATOR

Drug: Follitropine Bèta

Intervention Type OTHER

Interventions

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Drug: Follitropine Bèta

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

38 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Michael De Brucker

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael De Brucker, MD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

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UniversitairZB

Jette, , Belgium

Site Status RECRUITING

Countries

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Belgium

Facility Contacts

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Michael De Brucker, MD

Role: primary

024776699

Role: backup

003224776699

Other Identifiers

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IUI versus IVF/ICSI

Identifier Type: -

Identifier Source: org_study_id

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