Study on Progesterone and Estradiol for Infertility in Patients Undergoing Hormone Replacement Therapy with Frozen Embryo Transfer

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What is this study about?

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.

1 joining the trial

Upon joining the trial, you will be informed about the study’s purpose, procedures, and your role as a participant. You will be asked to provide consent to participate in the trial.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes checking your age, body mass index (BMI), and ensuring you have a day 5 vitrified blastocyst available for transfer after thawing.

3 medication administration

You will begin taking two medications: Cyclogest 400mg and Estrofem 2 mg Filmtabletten.

Cyclogest 400mg is administered rectally. The frequency and duration of administration will be explained to you by the study team.

Estrofem 2 mg Filmtabletten is taken orally. The dosage and schedule will be provided by the study team.

4 ongoing monitoring

Throughout the trial, you will undergo regular monitoring to assess your response to the treatment. This includes measuring hormone levels and checking for any side effects.

You will be asked to report any side effects or concerns you experience during the trial.

5 embryo transfer

A frozen embryo transfer will be performed as part of the trial. The timing and procedure will be coordinated by the study team.

6 follow-up assessments

After the embryo transfer, follow-up assessments will be conducted to monitor the pregnancy progress. This includes checking for a positive pregnancy test and ongoing pregnancy at week 12.

Additional assessments may include checking for any complications during pregnancy, such as hypertension or preeclampsia.

7 completion of trial

Upon completion of the trial, you will have a final assessment to review the outcomes and any remaining health considerations.

The study team will provide you with information on the results and any further steps if necessary.

Who Can Join the Study?

Age between 18 and 46 years old.
BMI (Body Mass Index) greater than 18.5 and less than 34 kg/m². BMI is a measure of body fat based on height and weight.
A Day 5 vitrified blastocyst must be available for transfer after thawing. A blastocyst is an early stage of embryo development, and vitrification is a method of freezing it.
Must be able to speak and understand Danish.
Participants must be female.

Who Cannot Join the Study?

Participants who are not experiencing infertility cannot join the study. Infertility means having difficulty getting pregnant after trying for a long time.
Only females are eligible to participate, so males cannot join the study.
Participants must be within a specific age range, so those outside this range cannot participate.
Individuals who are considered part of a vulnerable population are not allowed to join. A vulnerable population includes people who might need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Tqr Fmtvsjoij Cyhrfsl Sdwym Rwmzjfjp Hgcapwev	Skive	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not yet recruiting	01.08.2023

Trial locations

Investigated drugs:

Estradiol

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.

Investigated diseases:

Infertility

Infertility – Infertility is a condition where an individual is unable to conceive after a year of regular, unprotected sexual intercourse. It can affect both men and women and may result from various factors, including hormonal imbalances, structural problems, or issues with sperm or egg production. In women, infertility may be linked to ovulation disorders, blocked fallopian tubes, or uterine abnormalities. In men, it often involves low sperm count, poor sperm motility, or blockages that prevent sperm delivery. The progression of infertility depends on the underlying cause, which may remain stable or worsen over time. It can lead to emotional and psychological stress for those affected.

Trial ID:

2023-504616-15-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Progesterone and Estradiol for Infertility in Patients Undergoing Hormone Replacement Therapy with Frozen Embryo Transfer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?