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
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
-
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.