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Studier av graviditetsutfall hos kvinnor som genomgår frys-ET i naturlig cykel


- candidate number15827
- NTR NumberNTR4305
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-dec-2013
- Secondary IDsLutinusstudien 
- Public TitleStudier av graviditetsutfall hos kvinnor som genomgår frys-ET i naturlig cykel
- Scientific TitleStudier om hur resultaten påverkas av progesteronsubstitution i lutealfas vid frysåterföring i naturlig cykel, efter tidigare genomgången IVF-behandling
- ACRONYMLutstud
- hypothesisLutal support with vaginal progesteron after transfer of frozen, thawn embryos in natural cycles will improve the live birth rate, compared to natural cycles without lutal phase support
- Healt Condition(s) or Problem(s) studiedEmbryo, Progesterone, Natural cycle,
- Inclusion criteriaPatients planning frozen embryo transfer in a natural cycle
- Exclusion criteriaPatient who do not want to participate. Adverse effect of Lutinus.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2013
- planned closingdate31-dec-2015
- Target number of participants500
- InterventionsThe treatment (intervention) is substitution with vaginal tablets of Lutnius (progesterone) 100 mg two times daily, started on the day of embryo transfer and continued until 8 weeks of pregnancy, compared to no substitution. Patients are randomized after the embryo transfer, using closed envelopes. Blood samples are taken on the day of embryo transfer for analysis of serum progesterne and cytokine levels. Primary outcome is the rate of live birth per embryo transfer. Secondary endpoints are pregnancy rate, ongoing pregnancy rate, misscarriage rate and serum levels of progesterone and cytokines.
- Primary outcomeLive born child
- Secondary outcomePrennancy rate, ongoing pregnancy rate, misscarriage rate. Serum levels of progesterone and cytokines
- TimepointsThe primary endpoint live birth rate will be calculated after all data from the deliveries has been reported. The secondary outcome measure ongoing pregnancy will be used for interim analysis and finally when the study is closed to new patients and data are available. Serum anaylysis will be performed after closing the study.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD PhD Kjell Wånggren
- CONTACT for SCIENTIFIC QUERIESMD PhD Kjell Wånggren
- Sponsor/Initiator Uppsala Universty
- Funding
(Source(s) of Monetary or Material Support)
Ferring läkemedel AB
- PublicationsN/A
- Brief summaryRandomized controlled trial comparing pregnancy outcome after frozen embryo transfer in natural cycles with or without lutael phase support with vaginal progesterone
- Main changes (audit trail)
- RECORD5-dec-2013 - 7-apr-2014


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl