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A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying infertility and involves a treatment method used during a specific type of fertility procedure called hormone replacement therapy frozen embryo transfer (HRT-FET). The study will use two medications: Cyclogest 400mg, which contains the active substance progesterone and is administered rectally, and Estrofem 2 mg Filmtabletten, which contains estradiol and is taken orally. The purpose of the study is to explore the effectiveness of rectally administered progesterone in supporting the luteal phase, which is a part of the menstrual cycle, during HRT-FET cycles.
Participants in the study will receive treatment over a period of time, with the maximum treatment period for Cyclogest being 10 days and for Estrofem being 16 days. The study aims to determine if the rectal administration of progesterone is as effective as the traditional vaginal method in supporting pregnancy during these cycles. The study will also look at the optimal levels of progesterone in the blood after rectal administration and assess various outcomes such as ongoing pregnancy rates at 12 weeks, positive pregnancy tests, and any side effects or complications during pregnancy.
Throughout the study, participants will be monitored for different outcomes, including the rate of ongoing pregnancies, clinical pregnancies, and any pregnancy losses. The study will also evaluate the convenience and any side effects of using Cyclogest rectally. By the end of the study, researchers hope to gather valuable information on the effectiveness and safety of this treatment approach for individuals undergoing HRT-FET cycles.
The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.
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4 criteria
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Micronized Progesterone is a form of the hormone progesterone that has been processed into very small particles, making it easier for the body to absorb. In this clinical trial, it is administered rectally to support the luteal phase, which is a part of the menstrual cycle. This hormone is important for preparing the lining of the uterus to support a pregnancy. The trial is investigating whether this method of administering progesterone is as effective as the more common method of vaginal administration in helping women undergoing hormone replacement therapy for frozen embryo transfer cycles to achieve and maintain a pregnancy.
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