Condition category
Pregnancy and Childbirth
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
19/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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)20 566 3857
ofoproject@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Acronym

Study hypothesis

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

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

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/06/2002

Overall trial end date

01/07/2005

Reason abandoned

Eligibility

Participant 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%.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

250

Participant exclusion criteria

All couples in whom a reason is found for their subfertility or who are having another prognosis calculated

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

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor type

University/education

Website

http://www.amc.uva.nl/

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

Results in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abstract&list_uids=16844491

Publication citations

  1. Results

    Steures P, van der Steeg JW, Hompes PG, Habbema JD, Eijkemans MJ, Broekmans FJ, Verhoeve HR, Bossuyt PM, van der Veen F, Mol BW, , Intrauterine insemination with controlled ovarian hyperstimulation versus expectant management for couples with unexplained subfertility and an intermediate prognosis: a randomised clinical trial., Lancet, 2006, 368, 9531, 216-221, doi: 10.1016/S0140-6736(06)69042-9.

Additional files

Editorial Notes