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Does the time between the production of semen and Intra-Uterine Insemination has an impact on pregnancy rates? A prospective randomized clinical trial.


- candidate number10533
- NTR NumberNTR3144
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-nov-2011
- Secondary IDs2011/219 METc VUmc
- Public TitleDoes the time between the production of semen and Intra-Uterine Insemination has an impact on pregnancy rates? A prospective randomized clinical trial.
- Scientific TitleDoes the time between the production of semen and Intra-Uterine Insemination has an impact on pregnancy rates? A prospective randomized clinical trial.
- ACRONYMKLIPSI
- hypothesisTo evaluate if the pregnancy rate, number of ongoing pregnancies and the number of live births after IUI increases as the time between the production of semen and the IUI is shortened.
- Healt Condition(s) or Problem(s) studiedSubfertility
- Inclusion criteriaPatients who start their first IUI treatment. All subsequent cycles fall within this study. Only patients who undergo six IUI cycles, three times in a natural cycle and three times in a stimulated cycle, fall within this study. Patients who start a new IUI treatment after an ongoing pregnancy. Both IUI performed in a natural cycle and stimulated cycles fall within this study. Patients with well-adjusted, non-endocrine hormonal pathology fall within this study.
- Exclusion criteriaPatients who have IUI with donorsemen. Patients in which the semen was obtained in a different way than masturbation (bladder irrigation, electrical stimulation). Patients who have less than 0.5 million progressive motile sperm left over after work-up of semen. Patients with polycystic ovarian syndrome (PCOS). Patients with imminent ovarian failure (basal FSH> 10 IU / l).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2012
- planned closingdate1-jan-2016
- Target number of participants254
- InterventionsPatients are inseminated approximately 3-4 hours after the production of semen (Group I, current practice VUmc) or patients are inseminated as soon as possible after the production of semen (Group II, intervention group).
- Primary outcomeOngoing pregnancy rate per patient couple (positive fetal cardiac activity 10 weeks after IUI).
- Secondary outcomeClinical pregnancy rate per IUI cycle (HCG> 50 IU /l at 16 days after IUI). Ongoing pregnancy rate per IUI cycle (positive fetal cardiac activity 10 weeks after IUI). Percentage multiple pregnancies Percentage biochemical pregnancies and abortions Percentage/number of live births.
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc. C.G. Vergouw
- CONTACT for SCIENTIFIC QUERIESMSc. C.G. Vergouw
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- PublicationsN/A
- Brief summaryA single centre randomized controlled trial to evaluate if the pregnancy rate, number of ongoing pregnancies and the number of live births after IUI increases as the time between the production of semen and the IUI is shortened in couples with unexplained, cervical factor or male subfertility at the VU University Medical Center, The Netherlands.
- Main changes (audit trail)
- RECORD14-nov-2011 - 27-jul-2015


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