Condition category
Pregnancy and Childbirth
Date applied
08/02/2006
Date assigned
08/02/2006
Last edited
19/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs P Steures

ORCID ID

Contact details

Academic Medical Center
Center of Reproductive Medicine
OFO-project
H4-213
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5663857
ofoproject@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2

Study information

Scientific title

Acronym

Study hypothesis

1. We hypothesised a beneficial effect of IUI in couples with an isolated cervical factor
2. Furthermore we hypothesised that the post-coital test can identify those couples who would benefit from IUI without ovarian hyperstimulation

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Multicentre, randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Subfertility

Intervention

Couples were randomly allocated to IUI for six months or expectant management for six months. In the first three IUI cycles no controlled ovarian hyperstimulation (COH) was given. If these attempts failed subsequent IUI cycles were performed with COH.

Couples allocated to expectant management were followed until an ongoing pregnancy occurred within six months. If no pregnancy occurred, follow-up ended after this period. If a pregnancy miscarried, follow-up continued until the next pregnancy or the end of the six months period.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The primary endpoint was ongoing pregnancy within six months. Ongoing pregnancy was defined as the presence of foetal cardiac activity at transvaginal sonography at a gestational age of at least 12 weeks.

Secondary outcome measures

Secondary endpoints were total number of clinical pregnancies, miscarriages and multiple pregnancies.

Overall trial start date

01/06/2002

Overall trial end date

01/07/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Couples with a cervical factor and otherwise no factors that reduced their fertility i.e. a prognosis for a treatment independent ongoing pregnancy in the next year higher than 30%. A cervical factor was diagnosed by a well-timed, non-progressive post-coital test (PCT) with normal semen parameters.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

100

Participant exclusion criteria

All other subfertile couples

Recruitment start date

01/06/2002

Recruitment end date

01/07/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Center Amsterdam (The Netherlands)

Sponsor details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17482611

Publication citations

  1. Results

    Steures P, van der Steeg JW, Hompes PG, Bossuyt PM, Habbema JD, Eijkemans MJ, Schöls WA, Burggraaff JM, van der Veen F, Mol BW, , Effectiveness of intrauterine insemination in subfertile couples with an isolated cervical factor: a randomized clinical trial., Fertil. Steril., 2007, 88, 6, 1692-1696, doi: 10.1016/j.fertnstert.2007.01.124.

Additional files

Editorial Notes