Condition category
Pregnancy and Childbirth
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
15/01/2007
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

Dr I Custers

ORCID ID

Contact details

Academic Medical Center (AMC)
Department of Obstetrics and Gynecology
Center for Reproductive Medicine
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 4355 or +31 (0)20 566 9111
i.m.custers@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

SETI-study (Single Embryo Transfer or IUI)

Study hypothesis

One cycle of In-Vitro Fertilisation-elective Single Embryo Transfer (IVF-eSET) followed by transfer of frozen embryos is at least as effective as three cycles of Intra-Uterine Insemination-Controlled Ovarian Hyperstimulation (IUI-COH) in terms of ongoing pregnancy. Multiple pregnancies however can largely be prevented by treating women with IVF-eSET.

Ethics approval

Approval received from the ethics board of the Academic Medical Centre Amsterdam on March 6th 2006 (reference number: MEC 294).

Study design

Randomised, controlled, parallel group multicentre 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

Comparison of IVF in a long protocol with elective Single Embryo Transfer, and IUI-COH, in couples with unexplained or mild male subfertility and poor fertility prospects.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Ongoing pregnancy defined as registered heartbeat on ultrasound beyond 12 weeks of gestation.

Secondary outcome measures

1. Multiple pregnancy, defined as registered heartbeat of at least two foetuses at 12 weeks of gestation
2. Clinical pregnancy, defined as any registered embryonic heartbeat at sonography
3. Live birth, defined as the birth of at least one living child
4. Pregnancy complications (preterm birth less than 37 weeks, birth weight less than 2.5 gram, Pregnancy Induced Hypertension (PIH), (pre-) eclampsia, Haemolysis, Elevated Liver, Low Platelet [HELLP])

Overall trial start date

01/06/2006

Overall trial end date

01/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female age between 18 and 36 years
2. Couples must be diagnosed with unexplained subfertility, defined as normal semen (pre-wash total motile sperm count of at least 40 million), spontaneous ovulatory cycle and patent Fallopian tubes, or with mild male subfertility, defined as a post-wash total motile sperm count above three million
3. The couple has poor fertility prospects as calculated by the validated model of Hunault. A poor fertility prospect is defined as a chance of spontaneous pregnancy below 30% within 12 months

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

100

Participant exclusion criteria

1. Polycystic ovary syndrome
2. Endocrinopathological disease like: Cushing syndrome, adrenal hyperplasia, hyperprolactinemia, acromegaly, imminent ovarian failure, premature ovarian failure, hypothalamic amenorrhea, hypothyroidy, diabetes mellitus type I
3. If not willing or able to sign the consent form

Recruitment start date

01/06/2006

Recruitment end date

01/06/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Center (AMC) (The Netherlands)

Sponsor details

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Funders

Funder type

Industry

Funder name

Organon (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