#1 Clinical Trials Search in Europe

Progesterone

Progesterone, a crucial hormone in reproductive health, is the subject of several clinical trials aimed at understanding its effectiveness in various fertility and pregnancy-related scenarios. These studies explore the use of progesterone in in vitro fertilization (IVF), threatened miscarriage, and luteal phase support. The trials investigate different administration routes, dosages, and combinations to optimize outcomes for patients undergoing fertility treatments or experiencing pregnancy complications.

Table of Contents

What is Progesterone?

Progesterone is a natural hormone that plays a crucial role in the female reproductive system. It is often referred to as a “sex steroid” or “female hormone.” In medical treatments, progesterone is available in various forms, including vaginal suppositories, oral capsules, and injections. Some common brand names for progesterone include Utrogestan, Cyclogest, Prometrium, and Endometrin[1][2].

Medical Uses of Progesterone

Progesterone is used to treat various conditions related to women’s health. Some of the primary uses include:

  • Fertility treatments: Progesterone is commonly used in in vitro fertilization (IVF) and other assisted reproductive technologies to support embryo implantation and early pregnancy[2].
  • Luteal phase support: It helps prepare the uterus for pregnancy and maintains the uterine lining during early pregnancy[1].
  • Threatened miscarriage: Progesterone may be used to help prevent miscarriage in some cases of threatened pregnancy loss[6].
  • Menstrual irregularities: It can help regulate menstrual cycles, especially during the menopausal transition[7].
  • Hormone replacement therapy: Progesterone is used as part of hormone therapy for menopausal symptoms[7].

How Progesterone is Administered

Progesterone can be administered in several ways, depending on the specific condition being treated and the patient’s needs:

  • Vaginal suppositories or gels: Common in fertility treatments and early pregnancy support (e.g., Cyclogest, Crinone)[1][2].
  • Oral capsules: Used for various conditions, including luteal phase support and menopausal symptoms (e.g., Prometrium, Utrogestan)[2][7].
  • Injections: Sometimes used in fertility treatments, though less common due to discomfort[2].
  • Combination treatments: In some cases, progesterone may be used in combination with other hormones or medications[5].

Progesterone in Fertility Treatments

Progesterone plays a crucial role in fertility treatments, particularly in IVF and other assisted reproductive technologies. Here’s how it’s typically used:

  • Luteal phase support: After embryo transfer in IVF, progesterone is given to help prepare the uterus for implantation and support early pregnancy[1][2].
  • Frozen embryo transfer: Progesterone is used to prepare the uterine lining for the transfer of thawed embryos[5][8].
  • Recurrent implantation failure: Some studies are investigating whether extended progesterone treatment may help women who have experienced multiple failed IVF attempts[8].

Progesterone for Pregnancy Support

Progesterone is sometimes used to support pregnancy, particularly in certain high-risk situations:

  • Threatened miscarriage: For women experiencing vaginal bleeding in early pregnancy, progesterone may be prescribed to help prevent miscarriage[6].
  • IVF pregnancies: Women who become pregnant through IVF often continue progesterone supplementation through the first trimester[2].
  • HIV-positive pregnancies: Some studies are investigating the use of progesterone in HIV-positive pregnant women to potentially improve birth outcomes[4].

Progesterone During Menopausal Transition

During the menopausal transition, progesterone levels naturally decline. Supplementation may be used to:

  • Regulate menstrual cycles: Progesterone can help normalize irregular bleeding patterns common in perimenopause[7].
  • Manage symptoms: It may help with some menopausal symptoms, though more research is needed[7].
  • Potential metabolic effects: Some studies are investigating whether progesterone supplementation might help prevent weight gain during menopause by affecting resting energy expenditure[7].

Potential Side Effects and Considerations

While progesterone is generally well-tolerated, it can cause some side effects. These may include:

  • Vaginal discharge or discomfort (with vaginal forms)[5]
  • Drowsiness or dizziness[5]
  • Nausea or bloating[5]
  • Headaches[5]
  • Breast tenderness
  • Mood changes

It’s important to discuss any side effects with your healthcare provider. They can adjust your dosage or form of progesterone if needed. Additionally, progesterone may not be suitable for everyone, so a thorough medical history and consultation with a healthcare provider is essential before starting treatment[7].

Aspect Details
Study Types Randomized controlled trials, prospective cohort studies
Conditions Studied IVF/ICSI cycles, frozen embryo transfer, threatened miscarriage, recurrent implantation failure, HIV-positive pregnancy
Progesterone Forms Micronized progesterone, vaginal tablets/gel, oral tablets, intramuscular injections, subcutaneous injections
Administration Routes Vaginal, oral, intramuscular, subcutaneous, or combinations
Duration of Use Varies by study; typically from embryo transfer to 7-12 weeks of gestation if pregnancy occurs
Primary Outcomes Clinical pregnancy rates, live birth rates, ongoing pregnancy rates, miscarriage rates
Secondary Outcomes Birth weight, gestational age at delivery, implantation rates, safety and tolerability
Comparisons Different dosages, administration routes, combination therapies, placebo-controlled

FAQ

  • What is progesterone and why is it important in fertility treatments? Progesterone is a natural hormone that plays a vital role in preparing the uterus for pregnancy and maintaining it. In fertility treatments like IVF, progesterone is used for luteal phase support to help improve the chances of successful implantation and pregnancy.
  • How is progesterone administered in clinical trials? In the clinical trials, progesterone is administered through various routes, including vaginal (as tablets or gel), oral, intramuscular, and subcutaneous. Some studies compare different administration methods or combine multiple routes to determine the most effective approach.
  • What conditions are being studied in relation to progesterone use? The clinical trials are investigating progesterone use in several conditions, including IVF/ICSI cycles, frozen embryo transfer, threatened miscarriage, and recurrent implantation failure. Some studies also look at its potential benefits for HIV-positive pregnant women.
  • How long is progesterone typically used in these trials? The duration of progesterone use varies depending on the study and condition. In IVF trials, it's often used from the day of egg retrieval or embryo transfer until pregnancy is confirmed, and may continue up to 7-12 weeks of gestation if pregnancy occurs.
  • What are some of the outcomes being measured in these progesterone trials? The trials measure various outcomes, including clinical pregnancy rates, live birth rates, miscarriage rates, ongoing pregnancy rates, and birth weight. Some studies also assess the safety and tolerability of different progesterone regimens.

Ongoing Clinical Trials on Progesterone

  • Study of fixed-dose follitropin delta for ovarian stimulation in women undergoing intrauterine insemination treatment for infertility

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study Comparing Progesterone and Ganirelix for Preventing LH Surge in Women Undergoing Ovarian Stimulation for Egg Donation

    Recruiting

    3 1 1 1
    Investigated drugs:
    Spain

  • Study on Improving Sexual Health and Quality of Life in Cervical Cancer Patients Using Estriol, Estradiol Hemihydrate, and Promestriene

    Recruiting

    3 1 1 1
    Investigated drugs:
    Spain

  • Study on Infertility Treatment with Follitropin Alfa and Lutropin Alfa for Women Over 35 with Low Ovarian Response

    Recruiting

    3 1 1 1
    Investigated drugs:
    Spain

  • Study on Progesterone to Prevent Preterm Birth in Pregnant Women with Placenta Previa

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on the Effectiveness of Vaginal Micronized Progesterone for Infertility in Patients Undergoing Assisted Conception with Frozen Embryo Transfer (AC-FET)

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on GnRH Agonists for Ovulation and Luteal Support in IVF Patients: Comparing GnRH Agonist with hCG and Progesterone

    Recruiting

    3 1 1 1
    Investigated drugs:
    France

  • Study on the Effect of Ovarian Stimulation with Follitropin Delta, Triptorelin, and Progesterone in Women with Infertility of Advanced Age

    Recruiting

    3 1 1 1
    Investigated drugs:
    Spain

  • Study on Infertility: Effects of Choriogonadotropin Alfa, Nomegestrol Acetate, Estradiol Hemihydrate, and Progesterone in Patients Undergoing Frozen Embryo Transfer

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Progesterone as an Ovulation Trigger in Women with Infertility

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Portugal

Glossary

  • Progesterone: A natural hormone produced by the ovaries that plays a crucial role in preparing the uterus for pregnancy and maintaining it. In fertility treatments, synthetic forms are often used to support early pregnancy.
  • In Vitro Fertilization (IVF): A fertility treatment where eggs are fertilized with sperm outside the body in a laboratory, and the resulting embryos are then transferred into the uterus.
  • Luteal Phase Support: The use of hormones, typically progesterone, to support the uterine lining after ovulation or egg retrieval in fertility treatments, enhancing the chances of successful implantation and pregnancy.
  • Embryo Transfer: The procedure in IVF where embryos are placed into the uterus with the goal of achieving pregnancy.
  • Clinical Pregnancy: A pregnancy confirmed by both high levels of pregnancy hormone (hCG) in the blood and the presence of a gestational sac on ultrasound.
  • Threatened Miscarriage: A condition where vaginal bleeding occurs during early pregnancy, indicating a risk of miscarriage, but the pregnancy may still continue with appropriate care.
  • Recurrent Implantation Failure (RIF): A condition where women undergoing IVF have multiple unsuccessful embryo transfers despite having good quality embryos.
  • Frozen Embryo Transfer (FET): An IVF procedure where previously frozen embryos are thawed and transferred into the uterus.
  • Micronized Progesterone: A form of progesterone that has been processed to create very small particles, allowing for better absorption by the body.
  • Endometrium: The inner lining of the uterus that thickens each month in preparation for a potential pregnancy.

References

  1. https://clinicaltrials.gov/study/NCT05089383
  2. https://clinicaltrials.gov/study/NCT00296478
  3. https://clinicaltrials.gov/study/NCT04414020
  4. https://clinicaltrials.gov/study/NCT02400021
  5. https://clinicaltrials.gov/study/NCT03998761
  6. https://clinicaltrials.gov/study/NCT02690129
  7. https://clinicaltrials.gov/study/NCT04140968
  8. https://clinicaltrials.gov/study/NCT03504345