NCT01992731

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
138

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
1 year until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 27, 2015

Status Verified

March 1, 2015

Enrollment Period

2 years

First QC Date

November 12, 2013

Last Update Submit

March 25, 2015

Conditions

Infertility

Keywords

Age (38-42 years)pregnancy rates3 IUI cycles1 IVF/ICSI cycle

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Study Arms (2)

IUI group

ACTIVE COMPARATOR

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

IVF/ICSI arm

ACTIVE COMPARATOR

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

Interventions

Drug: Follitropine BètaOTHER
IUI groupIVF/ICSI arm

Eligibility Criteria

Age38 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UniversitairZB

Jette, Belgium

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Michael De Brucker, MD

    Universitair Ziekenhuis Brussel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 12, 2013

First Posted

November 25, 2013

Study Start

December 1, 2014

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

March 27, 2015

Record last verified: 2015-03

Locations

BE(1)