Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
3
Study information
Scientific title
A randomised clinical trial assessing the additional value of ovarian hyperstimulation in intrauterine insemination (IUI) for couples with an abnormal post-coital test (PCT)
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(s)
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
Study setting(s)
Not specified
Study 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
Primary outcome measure
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 study start date
01/06/2002
Overall study end date
01/07/2005
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Sex
Female
Target number of participants
250
Total final enrolment
265
Participant exclusion criteria
All other subfertile couples.
Recruitment start date
01/06/2002
Recruitment end date
01/07/2005
Locations
Countries of recruitment
Netherlands
Study participating centre
Academic Medical Center
Amsterdam
1100 DD
Netherlands
Funders
Funder type
Research organisation
Funder name
ZonMw
Alternative name(s)
Netherlands Organisation for Health Research and Development
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/12/2007 | 15/07/2021 | Yes | No |