Progesterone supplementation in natural cycles improves live birth rates after embryo transfer of frozen-thawed embryos—a randomized controlled trial

Randomized controlled trial comparing pregnancy outcome after frozen embryo transfer in natural cycles with or without lutael phase support with vaginal progesterone

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

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.

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.