Effectiveness of intrauterine insemination with ovarian hyperstimulation in couples with an unexplained moderately reduced fertility

ISRCTN	ISRCTN72675518
DOI	https://doi.org/10.1186/ISRCTN72675518
Protocol serial number	1
Sponsor	Academic Medical Centre (AMC) (Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Submission date: 20/12/2005
Registration date: 20/12/2005
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)20 566 3857
Email	ofoproject@amc.uva.nl

Study information

Primary study design	Interventional
Study design	Multicentre, randomised, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Secondary endpoints were total number of clinical pregnancies, miscarriages and multiple pregnancies.
Completion date	01/07/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	250
Key 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%.
Key exclusion criteria	All couples in whom a reason is found for their subfertility or who are having another prognosis calculated
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	15/07/2006		Yes	No