HER1: Reducing the Impact of Ovarian sTimulation – RIOT A
In recent years, it has become evident that a number of challenges remain to be overcome to improve IVF outcome. One of these relates to implantation.
Hormonal stimulation in connection to IVF treatment produces several mature follicles in the ovaries. This results in unnaturally high levels of estradiol and a premature progesterone rise – a side effect with impact on the receptivity of the lining of the womb for the embryo at transfer – making the conditions for a successful implantation suboptimal and may lead to a potential serious condition called Ovarian HyperStimulation Syndrome (OHSS).
This project investigates whether the conditions for implantation of the transferred embryo, and subsequently pregnancy outcome, can be improved by inhibiting the excess estradiol formation with an aromatase inhibitor (Letrozole®).
The effect of the treatment will be monitored through different primary and secondary outcome parameters where serum concentration of progesterone on day of ovulation trigger (human Chorion Gonadotropin injection) and levels of estradiol and progesterone are the most important. It is expected that Letrozole® will normalize the hormonal concentrations significantly compared to placebo. Ultimately, pregnancy rate will also be compared between the groups.
This study is a collaboration between the key investigator at Herlev Hospital and the fertility clinics at Rigshospitalet, Hvidovre and Holbæk.
130 women with normal ovarian function have finalized the double blinded placebo controlled randomized clinical trial. The process of analysis of the blood samples has just begun and we are very excited to see the results of the hormone analysis and in the end unblinding – the preliminary clinical results are positive.
This new intervention in the current IVF treatment can have very important implications for the future fertility treatment by ensuring a much safer method of treatment in cycles with fresh embryo transfer with a higher success rate without the feared side effects of ovarian hyperstimulation.