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
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