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)20 566 3857
ofoproject@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
Acronym
Study hypothesis
There is no additional benefit of Intrauterine Insemination (IUI) with Controlled Ovarian Hyperstimulation (COH) over expectant management for 6 months in couples with unexplained subfertility and a chance of a spontaneous pregnancy between 30% and 40%. Categorisation of unexplained subfertile couples by their prognosis can identify those couples who benefit from IUI with COH and those who do not.
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
Unexplained Subfertility
Intervention
After informed consent had been given, couples were randomly allocated between IUI with COH and expectant management for six months.
Couples allocated to IUI with COH started treatment in the next cycle. Controlled ovarian hyper stimulation as well as semen preparation and insemination regimens were performed according to hospital-specific protocols.
Couples allocated to expectant management were followed until an ongoing pregnancy occurred within six months, these pregnancies were finally followed until birth. 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 measure
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 (if study stopped)
Eligibility
Participant inclusion criteria
All subfertile couples in whom no reason is found during the basic fertility work-up for their subfertility and in whom their spontaneous pregnancy chance in the next year, calculated by the results of the basic fertility work-up, is between 30% and 40%.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
250
Participant exclusion criteria
All couples in whom a reason is found for their subfertility or who are having another prognosis calculated
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 Centre (AMC) (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
Basic results (scientific)
Publication list
Publication citations
-
Results
Steures P, van der Steeg JW, Hompes PG, Habbema JD, Eijkemans MJ, Broekmans FJ, Verhoeve HR, Bossuyt PM, van der Veen F, Mol BW, , Intrauterine insemination with controlled ovarian hyperstimulation versus expectant management for couples with unexplained subfertility and an intermediate prognosis: a randomised clinical trial., Lancet, 2006, 368, 9531, 216-221, doi: 10.1016/S0140-6736(06)69042-9.