A randomised clinical trial assessing the additional value of ovarian hyperstimulation in intrauterine insemination (IUI) for couples with an abnormal post-coital test (PCT)

ISRCTN	ISRCTN90142795
DOI	https://doi.org/10.1186/ISRCTN90142795
Secondary identifying numbers	3

Submission date: 08/02/2006
Registration date: 08/02/2006
Last edited: 15/07/2021

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	A randomised clinical trial assessing the additional value of ovarian hyperstimulation in intrauterine insemination (IUI) for couples with an abnormal post-coital test (PCT)
Study objectives	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
Health condition(s) or problem(s) studied	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
Completion date	01/07/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	250
Total final enrolment	265
Key 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%.
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

ZonMw
Private sector organisation / Other non-profit organizations

Alternative name(s): Netherlands Organisation for Health Research and Development
Location: Netherlands

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		01/12/2007	15/07/2021	Yes	No

Editorial Notes

15/07/2021: Publication reference and total final enrolment added.