The effectiveness of intrauterine insemination (IUI) in subfertile couples with an isolated cervical factor: a randomised controlled trial

ISRCTN	ISRCTN63217062
DOI	https://doi.org/10.1186/ISRCTN63217062
Secondary identifying numbers	2

Submission date: 08/02/2006
Registration date: 08/02/2006
Last edited: 19/10/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs P Steures
Scientific

Academic Medical Center
Center of Reproductive Medicine
OFO-project
H4-213
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone	+31 (0)20 5663857
Email	ofoproject@amc.uva.nl

Study information

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
Scientific title
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
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 study start date	01/06/2002
Completion date	01/07/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	100
Key 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.
Key exclusion criteria	All other subfertile couples
Date of first enrolment	01/06/2002
Date of final enrolment	01/07/2005

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Center

Amsterdam
1100 DD
Netherlands

Sponsor information

Academic Medical Center Amsterdam (The Netherlands)
University/education

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/12/2007		Yes	No