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
3
Study information
Scientific title
Acronym
Study hypothesis
We hypothesised that controlled ovarian hyperstimulation (COH) is of additional value to IUI in couples with a cervical factor and a poor prognosis, i.e. less than 30% spontaneous pregnancy chance in the next year.
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
These couples were randomly allocated to three cycles of IUI with COH or three cycles of IUI without COH. Controlled ovarian hyperstimulation as well as ovulation detection induction, semen preparation and insemination regimens were performed according to hospital-specific protocols.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The primary endpoint was ongoing pregnancy within three cycles of IUI. 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 were eligible if they had an abnormal PCT, either due to cervical hostility diagnosed by a well-timed, non-progressive PCT with normal semen parameters or due to a poor semen quality. The spontaneous pregnancy chance in the next year, leaving the result of the PCT out of consideration, was less than 30%.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
250
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