Lutal 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
ID
Bron
Verkorte titel
Aandoening
luteal support, progesterone, frozen embryo transfer, natural cycle
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Live born child
Achtergrond van het onderzoek
Randomized controlled trial comparing pregnancy outcome after frozen embryo transfer in natural cycles with or without lutael phase support with vaginal progesterone
Doel van het onderzoek
Lutal 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
Onderzoeksopzet
The 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.
Onderzoeksproduct en/of interventie
The 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.
Algemeen / deelnemers
Dept of Womens and Childrens Health,
Uppsala Universty.
Kjell Wånggren
[default]
The Netherlands
kjell.wanggren@kbh.uu.se
Wetenschappers
Dept of Womens and Childrens Health,
Uppsala Universty.
Kjell Wånggren
[default]
The Netherlands
kjell.wanggren@kbh.uu.se
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients planning frozen embryo transfer in a natural cycle
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Patient who do not want to participate.
Adverse effect of Lutinus.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL4152 |
NTR-old | NTR4305 |
Ander register | : Lutinusstudien |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |