Condition category
Pregnancy and Childbirth
Date applied
08/02/2006
Date assigned
08/02/2006
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 5663857
ofoproject@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

3

Study information

Scientific title

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

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

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/06/2002

Overall trial end date

01/07/2005

Reason abandoned

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

Patient

Age group

Adult

Gender

Female

Target number of participants

250

Participant exclusion criteria

All other subfertile couples.

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 Center Amsterdam (The Netherlands)

Sponsor details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes