Treatment of couples with unexplained subfertility and an unfavourable prognosis: a randomised trial comparing the effectiveness of intrauterine insemination with ovarian hyperstimulation and in-vitro fertilisation with single embryo transfer

ISRCTN	ISRCTN86744378
DOI	https://doi.org/10.1186/ISRCTN86744378
Secondary identifying numbers	NL811, NTR824

Submission date: 28/12/2006
Registration date: 28/12/2006
Last edited: 14/01/2021

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

Dr I Custers
Scientific

Academic Medical Center (AMC)
Department of Obstetrics and Gynecology
Center for Reproductive Medicine
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone	+31 (0)20 566 4355 or +31 (0)20 566 9111
Email	i.m.custers@amc.uva.nl

Study information

Study design	Randomised, controlled, parallel group multicentre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Treatment of couples with unexplained subfertility and an unfavourable prognosis: a randomised trial comparing the effectiveness of intrauterine insemination with ovarian hyperstimulation and in-vitro fertilisation with single embryo transfer
Study acronym	SETI-study (Single Embryo Transfer or IUI)
Study objectives	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(s)	Approval received from the ethics board of the Academic Medical Centre Amsterdam on March 6th 2006 (reference number: MEC 294).
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/06/2006
Completion date	01/06/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	100
Total final enrolment	116
Key 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
Key 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
Date of first enrolment	01/06/2006
Date of final enrolment	01/06/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Center (AMC)

Amsterdam
1100 DD
Netherlands

Sponsor information

Academic Medical Center (AMC) (The Netherlands)
Hospital/treatment centre

P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Website	http://www.amc.uva.nl/#http://www.amc.uva.nl/
"ROR"	https://ror.org/03t4gr691

Funders

Funder type

Industry

Organon (The Netherlands)

No information available

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	results	01/11/2011	14/01/2021	Yes	No

Editorial Notes

14/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.