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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR824 |
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Date of registration:
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23/11/2006 |
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Primary sponsor: |
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Public title:
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Treatment of couples with unexplained subfertility and an unfavourable prognosis. A randomised trial comparing the effectiveness of IUI with ovarian hyperstimulation and IVF with single embryo transfer.
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Scientific title:
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Treatment of couples with unexplained subfertility and an unfavourable prognosis. A randomised trial comparing the effectiveness of IUI with ovarian hyperstimulation and IVF with single embryo transfer. - SETI-study (Single Embryo Transfer or IUI) |
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Date of first enrolment:
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1/6/2006 |
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Target sample size:
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100 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=824 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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I.
Custers |
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Address:
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Academic Medical Center (AMC), Department of Obstetrics and Gynecology, Center for Reproductive Medicine
P.O. Box 22660, Meibergdreef 9
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5664355 or +31 (0)20 5669111 |
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Email:
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i.m.custers@amc.uva.nl |
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Affiliation:
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Name:
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Fulco
Veen, van der |
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Address:
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Academic Medical Center (AMC), Department of Obstetrics and Gynecology, Center For Reproductive Medicine,
P.O. Box 22660, Meibergdreef 9
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5663557 |
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Email:
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F.vanderVeen@amc.uva.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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 3 million;
3. The couple has poor fertility prospects as calculated by the validated model of Hunault (Hunault et al., 2005, Van der Steeg et al., Submitted). A poor fertility prospect is defined as a chance of spontaneous pregnancy below 30% within 12 months.
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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Unexplained subfertility
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Intervention(s)
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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.
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Primary Outcome(s)
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Ongoing pregnancy defined as registered heartbeat on ultrasound beyond 12 weeks of gestation.
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Secondary Outcome(s)
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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 < 37 weeks, birth weight < 2.500 gram, Pregnancy Induced Hypertension (PIH), (pre-) eclampsia, HELLP).
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Secondary ID(s)
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ISRCTN86744378
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N/A
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Source(s) of Monetary Support
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Organon
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