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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: |
NTR939 |
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Date of registration:
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21/03/2007 |
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Primary sponsor: |
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Public title:
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Prevention of multiple pregnancies in couples with unexplained or mild male subfertility
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Scientific title:
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Treatment of couples with unexplained or mild male subfertility and an unfavorable prognosis. A randomised trial comparing the cost-effectiveness of IUI with ovarian hyperstimulation, manipulated natural cycle IVF and IVF with single embryo transfer. - INeS-study |
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Date of first enrolment:
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1/7/2007 |
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Target sample size:
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600 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=939 |
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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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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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Name:
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M.H.
Mochtar |
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Address:
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Academical Medical Center, Center for Reproductive Medicine, Postbox 22700
1100 DE
Amsterdam
The Netherlands |
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Telephone:
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Email:
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M.H.Mochtar@amc.uva.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Couples are eligible if the following apply:
1. Female age between 18 and 38 years.
2. Failure to conceive within at least 12 months of unprotected intercourse.
3. The couple has poor fertility prospects as calculated by the validated model of Hunault (Hunault et al., 2005; Van der Steeg et al., 2006). A poor fertility prospect is defined as a chance of spontaneous pregnancy below 30% within 12 months.
Exclusion criteria: Couples must not be entered if any of the following apply:
1. Polycystic ovary syndrome or any other anovulation.
2. Post-wash total motile sperm count below 3 million.
3. Double-sided tubal pathology.
4. Endocrinopathological disease like: Cushing syndrome, adrenal hyperplasia, hyperprolactinemia, acromegaly, imminent ovarian failure, premature ovarian failure, hypothalamic amenorrhea, hypothyroidy, diabetes mellitus type I.
5. Negative post-coitus test.
6. 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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Labour, In vitro fertilization (IVF), Pregnancy outcome, Pregnancy multiple, Insemination artificial, Embryo transfer, Patient preference
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Intervention(s)
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The comparisons are six cycles of intra-uterine insemination with controlled ovarian hyperstimulation, six cycles of manipulated natural cycle IVF, and three cycles with IVF-eSET plus cryo-cycles within a time frame of 10 months.
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Primary Outcome(s)
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Birth of a healthy child.
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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. Neonatal mortality;
4. Pregnancy complications (preterm birth < 37 weeks, birth weight < 2.500 gram, Pregnancy Induced Hypertension (PIH), (pre-) eclampsia, HELLP);
5. Costs.
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Secondary ID(s)
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ISRCTN52843371
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Source(s) of Monetary Support
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ZON-MW, The Netherlands Organization for Health Research and Development
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