Infertility female – Trials in Disease

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Ongoing Clinical Trials for Female Infertility

There are currently 15 ongoing clinical trials investigating various treatments and approaches for female infertility. These studies are exploring different medications, hormonal therapies, and procedures to improve fertility outcomes, including ovarian stimulation protocols, egg maturation techniques, diagnostic procedures, and lifestyle interventions. Trials are being conducted across several European countries, offering opportunities for women experiencing difficulties conceiving to participate in research that may help advance treatment options.

Clinical trial locations

Study Comparing Medroxyprogesterone Acetate and Ganirelix for Women Undergoing Fertility Treatment with Embryo Accumulation

This trial is designed for women who are undergoing a specific fertility treatment approach called DUOSTIM, which involves stimulating the ovaries twice to collect more eggs for genetic testing. The main focus is comparing two different methods of controlling hormone levels during this process.

Who can participate: Women under 43 years of age with regular menstrual cycles lasting between 21 and 35 days are eligible. Participants must have both ovaries present and require in vitro fertilization with genetic testing of embryos. They must be willing and able to complete the study and provide informed consent.

Who cannot participate: No specific exclusion criteria were provided for this trial.

What the study involves: The trial compares two medications used to prevent premature ovulation during fertility treatment. One group receives Progevera, a tablet containing medroxyprogesterone acetate, while the other receives Ganirelix, given as an injection under the skin. Both medications help control hormone levels to optimize the timing of egg collection.

Main goal: The study aims to determine whether there is a difference in the number of healthy embryos with the correct number of chromosomes produced using these two different approaches. This information could help improve treatment options for women undergoing fertility preservation or treatment.

Study on Corifollitropin Alfa and Follitropin Beta for Women with Infertility Undergoing Ovarian Stimulation with Medroxyprogesterone Acetate

This study explores the effectiveness of two different medications used to stimulate the ovaries to produce eggs. The trial is designed for women who are egg donors and compares the results of using Corifollitropin alfa versus Follitropin beta.

Who can participate: Women between 18 and 35 years old with regular menstrual cycles of 25 to 35 days and a body mass index between 18 and 28 are eligible. Participants must be free from physical and mental illness, have normal uterine and ovarian structure without polycystic ovaries, and have an antral follicle count greater than 12. They must also have a normal karyotype and test negative for infectious diseases including Hepatitis B, Hepatitis C, HIV, and Syphilis. Normal results in general health tests are required.

Who cannot participate: Women with medical conditions that could interfere with the study, those using medications that could affect results, those with allergies to study medications, pregnant or breastfeeding women, those with significant health issues, recent participants in other clinical trials, those with mental health conditions, substance abuse issues, or conditions requiring regular use of certain interfering medications are excluded.

What the study involves: Participants receive either Corifollitropin alfa or Follitropin beta through injections under the skin to stimulate their ovaries. Medroxyprogesterone acetate is also used to prevent early preparation for pregnancy, which can interfere with successful egg collection. The study monitors the number and maturity of eggs produced.

Main goal: The trial aims to compare which medication is more effective in producing a higher number of mature eggs suitable for donation. The findings could provide valuable information for improving egg donation programs and fertility treatments.

Study on Exercise, Mediterranean Diet, and Aspirin for Women with Infertility Undergoing In Vitro Fertilization

This trial investigates whether lifestyle interventions or medication can improve the success rates of in vitro fertilization. The study compares exercise combined with a Mediterranean diet, aspirin treatment, or no intervention.

Who can participate: Women over 18 years old experiencing primary infertility who are candidates for single embryo transfer on day 5 are eligible. Participants must provide written consent to join the study.

Who cannot participate: Men cannot participate, and women who are not experiencing infertility or those considered part of a vulnerable population are excluded.

What the study involves: Participants are randomly assigned to one of three groups: following an exercise and Mediterranean diet program, taking aspirin in the form of TROMALYT prolonged-release capsules, or receiving no intervention. The study monitors participants through their IVF treatment to assess outcomes.

Main goal: The primary aim is to determine which approach leads to the highest rate of live births after IVF. This research could help guide future treatment recommendations for women facing fertility challenges and provide insights into the role of lifestyle and medication in supporting successful pregnancies.

Study on Progesterone for Improving Birth Rates in Couples with Unexplained Infertility Undergoing Mild Ovarian Stimulation and Intrauterine Insemination

This trial examines whether adding progesterone support during a specific phase of the menstrual cycle can increase the chances of live birth for couples with unexplained infertility undergoing intrauterine insemination with mild ovarian stimulation.

Who can participate: Participants must have a diagnosis of unexplained subfertility based on national guidelines, a Hunault score less than 30 percent, be between 18 and 43 years old, have a body mass index less than 45, have been trying to conceive for at least one year, have regular menstrual cycles, and have a total mobile sperm count greater than 10 million. They must be starting their first mild ovarian stimulation cycle with the intent to continue for at least six months.

Who cannot participate: Women who are not experiencing unexplained subfertility or infertility, men, and those considered part of a vulnerable population are excluded.

What the study involves: Participants are randomly assigned to receive either Utrogestan soft vaginal capsules containing progesterone or a placebo. The medication is administered daily during the luteal phase, which is the time after ovulation. FSH is used for mild ovarian stimulation, and participants are monitored for pregnancy outcomes over six months.

Main goal: The study aims to determine if progesterone support increases the likelihood of pregnancy leading to a live birth within six months. Secondary outcomes include clinical pregnancy rates, miscarriage rates, quality of life assessments, and cost-effectiveness of the treatment.

Study on Random Start Ovarian Stimulation with Follitropin Alfa, Dydrogesterone, and Triptorelin Acetate for Women Undergoing Elective Oocyte Cryopreservation to Prevent Infertility

This study investigates a new method called Random Start Ovarian Stimulation, which allows ovarian stimulation to begin at any point in the menstrual cycle rather than waiting for a specific phase. The goal is to determine if this approach is as effective as traditional timing for egg freezing.

Who can participate: Women between 25 and 39 years old with a body mass index between 18 and 30, regular menstrual cycles of 24 to 35 days, and normally accessible ovaries are eligible. Participants must sign an informed consent form and not be taking hormonal birth control, or must have stopped at least two months prior.

Who cannot participate: Women outside the specified age range or those considered part of a vulnerable population are excluded.

What the study involves: Participants receive follitropin alfa through subcutaneous injection using a pre-filled pen, dydrogesterone as oral tablets, and triptorelin acetate via subcutaneous injection. The dosage and frequency are determined by the study team. Regular monitoring includes blood tests and ultrasound examinations to assess ovarian response.

Main goal: The trial aims to compare the effectiveness of Random Start Ovarian Stimulation with traditional early-cycle stimulation in producing mature eggs for freezing. The findings could improve fertility preservation techniques by offering more flexible timing options for women.

Study on the Effect of Metformin on Endometrial Function in Women with Unexplained Infertility

This trial evaluates whether Metformin, a medication commonly used for diabetes, can improve the function of the uterine lining and enhance fertility in women with unexplained infertility.

Who can participate: Women between 20 and 40 years old who have been unable to conceive for at least 12 months, diagnosed with idiopathic infertility, are eligible. Participants must not have used hormone therapy or contraception for 30 days before the study, have a body mass index between 18.5 and 30, and be eligible for in vitro fertilization.

Who cannot participate: Women not diagnosed with idiopathic infertility, men, women outside the specified age range, and those considered part of a vulnerable population are excluded.

What the study involves: Participants are randomly assigned to receive either Metformin in the form of GLUCOPHAGE 500 mg tablets or a placebo, taken orally. The study is double-blind, meaning neither participants nor researchers know who receives which treatment. Regular follow-up visits include blood tests to assess various fertility-related markers, and endometrial tissue may be analyzed. Quality of life assessments are also conducted.

Main goal: The primary aim is to determine if Metformin can increase pregnancy rates in women with unexplained infertility by improving endometrial function. The study also examines how Metformin affects biological markers in the blood and genetic material in endometrial tissues.

Study on the Effect of Oil-Based Tubal Flushing with Ethyl Esters of Iodised Fatty Acids on Pregnancy in Infertile Women with One Open Fallopian Tube

This trial investigates whether an additional procedure called tubal flushing with an oil-based contrast after a diagnostic test can improve the chances of achieving a live birth in women with at least one open fallopian tube.

Who can participate: Women between 18 and 39 years old who have experienced infertility for at least 12 months, or have tried donor sperm at least three times, or have undergone at least three cycles of ovulation treatment without success are eligible. Participants must have at least one open fallopian tube confirmed by Hysterosalpingo-foam sonography and be undergoing this test as part of their fertility evaluation.

Who cannot participate: Women who are not infertile, do not have at least one open fallopian tube, men, and those considered part of a vulnerable population are excluded.

What the study involves: After undergoing the diagnostic test called Hyfosy, participants are randomly assigned to either receive additional tubal flushing with Lipiodol Ultra-Fluide, an oil-based solution, or not receive this additional procedure. The solution is injected into the uterus, and participants are monitored for up to six months to track pregnancy and live birth outcomes.

Main goal: The study aims to determine if the additional tubal flushing procedure increases the likelihood of live birth within six months. This research could help establish whether this relatively simple additional step can improve fertility outcomes for women with at least one open fallopian tube.

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

This trial explores the effects of different intensities of ovarian stimulation on the development of healthy embryos in older women undergoing fertility treatment. The study compares two doses of follitropin delta to determine which is more effective.

Who can participate: Women between 38 and 41 years old with an anti-Müllerian hormone level between 1.5 and 3.5 ng/ml and a body mass index between 18.5 and 30 are eligible. Participants must be undergoing IVF and preimplantation genetic screening to check embryos for genetic issues.

Who cannot participate: Women not experiencing infertility, those outside the specified age range, men, and those considered part of a vulnerable population are excluded.

What the study involves: Participants receive triptorelin as a subcutaneous injection to prepare the body, followed by either 15 or 20 micrograms of follitropin delta daily, also given as subcutaneous injections. The duration depends on ovarian response, monitored through regular check-ups. Progesterone is taken orally in capsule form. Hormone levels are monitored throughout, and eggs are retrieved and fertilized in a laboratory. Embryos are evaluated for quality and genetic normalcy before transfer to the uterus.

Main goal: The trial aims to determine the most effective dose of follitropin delta for producing healthy embryos in women of advanced age. The findings could help optimize treatment plans for older women seeking fertility treatment and improve their chances of successful pregnancy.

Study on the Effects of Follitropin Beta and Corifollitropin Alfa for Patients with Subfertility Undergoing ICSI Treatment

This study aims to find the optimal dosing of recombinant FSH after using corifollitropin alfa in women undergoing intracytoplasmic sperm injection, a specialized form of in vitro fertilization.

Who can participate: Women between 18 and 40 years old with a body mass index of 29 or less, regular menstrual cycles lasting 26 to 35 days, and specific body weight requirements based on age are eligible. Participants must have normal hormone levels and ultrasound results, with no hormonal treatment in the month prior to starting the treatment cycle. They must not have had more than three unsuccessful IVF/ICSI cycles since their last ongoing pregnancy and must have an antral follicle count between 7 and 20.

Who cannot participate: Women with medical conditions that would make participation unsafe, those using medications that could interfere with results, those with allergies to study substances, pregnant or breastfeeding women, recent participants in other trials, those with serious health issues, those with a history of substance abuse, those with mental health conditions affecting participation, and those with conditions affecting their ability to understand study requirements are excluded.

What the study involves: Participants receive an initial injection of Elonva 150 micrograms under the skin, followed by Puregon injections in various dosages. Regular monitoring of hormone levels and ovarian response is conducted throughout treatment. The number of eggs retrieved and various pregnancy outcomes are recorded.

Main goal: The trial seeks to optimize the dosing regimen for women undergoing ICSI treatment to achieve the best possible outcomes in terms of hormone levels, egg retrieval, and pregnancy rates.

Study Comparing Intranasal Nafarelin and Subcutaneous Triptorelin for Final Egg Maturation in Women with Infertility

This trial compares two different methods of triggering final egg maturation during fertility treatment: an intranasal spray versus an injection under the skin.

Who can participate: Women between 18 and 35 years old who are egg donors undergoing progesterone-primed ovarian stimulation with any available hormone medications are eligible. Participants must have a body mass index between 18 and 30 and at least 10 follicles with an average diameter of 14mm or more on the last ultrasound before trigger medication.

Who cannot participate: Women with medical conditions that could interfere with the study, those using medications that could affect results, those with allergies to study medications, pregnant or breastfeeding women, those with significant health issues, recent participants in other trials, those with mental health conditions, those with substance abuse issues, and those with other conditions deemed unsafe by study doctors are excluded.

What the study involves: Participants are randomly assigned to receive either nafarelin as a nasal spray or triptorelin as an injection under the skin to trigger final egg maturation. Both medications help eggs reach their final stage of development for retrieval. The study monitors the number of mature eggs retrieved, hormone levels, side effects, and participant preferences regarding the medications.

Main goal: The trial aims to determine whether the intranasal spray is as effective as the injection for triggering egg maturation, and to gather information about participants’ experiences and preferences. This could potentially offer a more convenient administration option for fertility treatments.

Study Comparing Oil-Based and Water-Based Contrast Media for Infertility in Women: Iodixanol and Ethyl Esters of Iodised Fatty Acids from Poppyseed Oil

This trial compares two types of contrast media used during hysterosalpingography, a special X-ray test to examine the uterus and fallopian tubes. The study investigates which type is more effective in helping women achieve successful pregnancy.

Who can participate: Women with infertility, ovulation disorders with less than 8 menstrual cycles per year, or those at high risk for tubal pathology are eligible. High risk includes history of chlamydia infection, pelvic inflammatory disease, known endometriosis, abdominal surgery, or peritonitis. Women above 38 years of age are also eligible.

Who cannot participate: Women not experiencing infertility, men, those outside the specified age range, and those considered part of a vulnerable population are excluded.

What the study involves: Participants are randomly assigned to receive either Visipaque, a water-based contrast media, or Lipiodol Ultra Fluide, an oil-based contrast media, during their hysterosalpingography procedure. Some may receive a placebo. The contrast media is injected into the uterus to create clear images. Participants are monitored for up to six months for pregnancy outcomes, complications, thyroid function, and overall health.

Main goal: The primary aim is to determine which type of contrast media is more effective in helping women conceive and achieve live birth. The study also examines time to pregnancy, various pregnancy outcomes, and potential complications to provide comprehensive information on the best approach for diagnostic imaging in fertility evaluation.

Summary

The 15 ongoing clinical trials for female infertility represent a diverse range of research approaches spanning multiple European countries. Spain hosts the majority of trials with 10 studies, followed by Belgium with 3 trials, and the Netherlands with 2 trials. Italy and Poland each host 1 trial, with one study conducted across both Spain and Italy.

A significant focus of these trials is on optimizing ovarian stimulation protocols, with multiple studies investigating different doses and combinations of hormones such as follitropin alfa, follitropin beta, follitropin delta, corifollitropin alfa, and menotrophin. Several trials specifically examine treatments for women of advanced reproductive age or those with low ovarian response to previous treatments.

The research also explores alternative approaches beyond hormonal treatments, including lifestyle interventions combining exercise and Mediterranean diet, the use of metformin for unexplained infertility, and diagnostic procedures using different contrast media for tubal evaluation. Progesterone supplementation is investigated in multiple forms and delivery methods across several trials.

These studies address various causes of infertility, including unexplained infertility, tubal factors, ovulation disorders, and age-related fertility decline. The trials employ rigorous scientific methods, including randomization and blinding where appropriate, to ensure reliable results that could improve treatment options for women experiencing difficulty conceiving.

Ongoing Clinical Trials on Infertility female

  • Study on Corifollitropin Alfa and Follitropin Beta for Women with Infertility Undergoing Ovarian Stimulation with Medroxyprogesterone Acetate

    Recruiting

    3 1 1 1
    Investigated diseases:
    Spain
  • Study on the Effect of Metformin on Endometrial Function in Women with Unexplained Infertility

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Poland
  • Study on Exercise, Mediterranean Diet, and Aspirin for Women with Infertility Undergoing In Vitro Fertilization

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain
  • Study on Random Start Ovarian Stimulation with Follitropin Alfa, Dydrogesterone, and Triptorelin Acetate for Women Undergoing Elective Oocyte Cryopreservation to Prevent Infertility

    Recruiting

    3 1 1 1
    Investigated diseases:
    Belgium
  • Study of Rituximab Treatment for Women with Autoimmune Premature Ovarian Insufficiency to Improve Fertility

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Sweden
  • Study of testosterone gel treatment for women with low ovarian reserve and androgen receptor polymorphism undergoing fertility treatment

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Spain
  • Study on the Effect of Oil-Based Tubal Flushing with Ethyl Esters of Iodised Fatty Acids on Pregnancy in Infertile Women with One Open Fallopian Tube

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Belgium
  • Study on Ovarian Response in Women with Infertility Using Follitropin Delta and Menotrophin During Assisted Reproductive Technology

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Italy Spain
  • Study on Progesterone for Improving Birth Rates in Couples with Unexplained Infertility Undergoing Mild Ovarian Stimulation and Intrauterine Insemination

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands