In short
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.
At a glance
- 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
What is Progesterone PH. EUR.?
Progesterone PH. EUR. is the active substance in a medication called Cyclogest 400mg. 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). 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. 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. This typically means two 400mg pessaries per day. The maximum treatment period in the trial is 10 days. 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. 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.
Patients with the following conditions should not use this medication:
- Inflammatory bowel disease (such as ulcerative colitis or Crohn's disease)
- Known allergy or contraindication to Cyclogest or its components
- Severe chronic medical conditions
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
- Have a day 5 vitrified blastocyst available for transfer
- Have an endometrium thickness of at least 7 mm after 12-20 days of estradiol treatment
- Do not have uterine abnormalities
- Are not undergoing oocyte donation
- Are not taking medications metabolized by CYP3A4 enzymes
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.