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Progesterone Ph. Eur.

This article discusses a clinical trial investigating the use of rectally administered progesterone (Cyclogest 400mg) for luteal phase support in hormone replacement therapy frozen embryo transfer (HRT-FET) cycles. The study aims to compare the effectiveness of rectal progesterone administration to vaginal administration, focusing on ongoing pregnancy rates and other important outcomes in infertility treatment.

Table of Contents

What is Progesterone PH. EUR.?

Progesterone PH. EUR. is the active substance in a medication called Cyclogest 400mg[1]. Progesterone is a naturally occurring hormone in the female body that plays a crucial role in pregnancy and the menstrual cycle. The “PH. EUR.” in the name stands for “European Pharmacopoeia,” which indicates that this form of progesterone meets specific quality standards set by European regulations.

Medical Uses

Cyclogest 400mg, containing Progesterone PH. EUR., is primarily used in fertility treatments, specifically for luteal phase support in women undergoing hormone replacement therapy with frozen embryo transfer (HRT-FET)[1]. The luteal phase is a critical period in the menstrual cycle that occurs after ovulation and before the next menstrual period. During fertility treatments, supporting this phase with progesterone can help improve the chances of a successful pregnancy.

This medication is used to:

  • Prepare the uterus lining (endometrium) for embryo implantation
  • Support early pregnancy after embryo transfer
  • Help maintain pregnancy in its early stages

How is it Administered?

In the clinical trials being conducted, Cyclogest 400mg is being studied for rectal administration[1]. This means the medication is inserted into the rectum rather than taken orally or vaginally. This method of administration is being explored as an alternative to vaginal application, which is more commonly used in fertility treatments.

Dosage Information

According to the clinical trial information, the maximum daily dose of Cyclogest 400mg is 800 mg[1]. This typically means two 400mg pessaries per day. The maximum treatment period in the trial is 10 days[1]. However, it’s important to note that your doctor will prescribe the exact dosage and duration based on your individual needs and treatment plan.

Current Clinical Trials

Cyclogest 400mg is currently being studied in clinical trials to investigate its effectiveness when administered rectally for luteal phase support in HRT-FET cycles[1][2]. The main objective of these trials is to determine if rectally administered progesterone is as effective as vaginally administered progesterone in supporting ongoing pregnancy rates at 12 weeks.

The trials are also looking at several secondary outcomes, including:

  • Positive pregnancy test rates
  • Clinical pregnancy rates
  • Live birth rates
  • Progesterone levels in blood and urine
  • Side effects and patient comfort with rectal administration
  • Pregnancy complications such as hypertension and preeclampsia

Potential Side Effects and Precautions

While the full range of side effects is still being studied, patients should be aware of potential discomfort associated with rectal administration. The clinical trials are specifically looking at side effects and patient convenience regarding rectal administration of Cyclogest[1][2].

Patients with the following conditions should not use this medication:

  • Inflammatory bowel disease (such as ulcerative colitis or Crohn’s disease)[1]
  • Known allergy or contraindication to Cyclogest or its components[1]
  • Severe chronic medical conditions[1]

Who Can Use This Medication?

Based on the clinical trial criteria, this medication may be suitable for women who:

  • Have a BMI between 18.5 and 34 kg/m²[1]
  • Have a day 5 vitrified blastocyst available for transfer[1]
  • Have an endometrium thickness of at least 7 mm after 12-20 days of estradiol treatment[1]
  • Do not have uterine abnormalities[1]
  • Are not undergoing oocyte donation[1]
  • Are not taking medications metabolized by CYP3A4 enzymes[1]

It’s important to note that this medication should only be used under the supervision of a healthcare professional specializing in fertility treatments. Your doctor will determine if this medication is appropriate for you based on your individual medical history and treatment plan.

Aspect Details
Study Drug Cyclogest 400mg (Progesterone Ph. Eur.)
Administration Route Rectal
Primary Objective Investigate ongoing pregnancy rate at week 12 in HRT-FET cycles
Max Daily Dose 800 mg
Treatment Duration Up to 10 weeks
Key Inclusion Criteria BMI 18.5-34 kg/m², Day 5 vitrified blastocyst available
Key Exclusion Criteria Inflammatory bowel disease, uterine abnormalities, oocyte donation
Secondary Outcomes Positive hCG rate, clinical pregnancy, side effects, pregnancy complications

FAQ

  • What is the main goal of this clinical trial? The main goal is to investigate the ongoing pregnancy rate at week 12 in HRT-FET cycles using rectally administered progesterone as the only form of progesterone support, and to determine if it is non-inferior to vaginal luteal phase support.
  • Who can participate in this study? Participants must have a BMI between 18.5 and 34 kg/m², have a day 5 vitrified blastocyst available for transfer after thawing, and be able to speak and understand Danish. There are also several exclusion criteria, such as having inflammatory bowel disease or uterine abnormalities.
  • What is Cyclogest 400mg? Cyclogest 400mg is a pessary (a solid medication designed to be inserted into the body) containing progesterone, which is being used in this trial for luteal phase support in frozen embryo transfer cycles.
  • What are some of the secondary outcomes being studied? Secondary outcomes include positive hCG rate, clinical pregnancy rate, pregnancy loss, live birth rate, mean progesterone levels, side effects, patient convenience, and pregnancy complications such as hypertension and preeclampsia.
  • How long does the treatment last in this trial? The maximum treatment period in this trial is 10 weeks, with a maximum daily dose of 800 mg of progesterone administered rectally.

Ongoing Clinical Trials on Progesterone Ph. Eur.

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

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

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

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

Glossary

  • HRT-FET: Hormone Replacement Therapy Frozen Embryo Transfer: A fertility treatment where hormones are used to prepare the uterus for the transfer of a previously frozen embryo.
  • Luteal Phase Support (LPS): The use of hormones, typically progesterone, to support the uterine lining after ovulation or embryo transfer in fertility treatments.
  • Progesterone: A hormone crucial for maintaining pregnancy, often used in fertility treatments to support the uterine lining.
  • Blastocyst: An early stage embryo, typically 5-6 days old, consisting of about 100 cells.
  • Vitrification: A fast-freezing technique used to preserve embryos for future use in fertility treatments.
  • hCG: Human Chorionic Gonadotropin: A hormone produced during pregnancy, often used as an indicator of pregnancy in fertility treatments.
  • Endometrium: The inner lining of the uterus, which thickens in preparation for possible embryo implantation.
  • BMI: Body Mass Index: A measure of body fat based on height and weight.
  • Pessary: A solid medication designed to be inserted into the body, in this case, containing progesterone for rectal or vaginal use.
  • CYP3A4 enzymes: Enzymes in the body that help metabolize certain medications. Some patients taking drugs processed by these enzymes are excluded from the study.

References

  1. http://clinicaltrials.eu/trial/study-on-progesterone-and-estradiol-for-infertility-in-patients-undergoing-hormone-replacement-therapy-with-frozen-embryo-transfer/
  2. http://clinicaltrials.eu/trial/study-on-progesterone-and-estradiol-for-infertility-in-patients-undergoing-hormone-replacement-therapy-with-frozen-embryo-transfer-2/