Ongoing Clinical Trials for Infertility
Currently, there are 13 ongoing clinical trials focused on infertility, exploring various treatment approaches including hormonal medications, embryo transfer techniques, and ovarian stimulation protocols. These trials are being conducted across several European countries, including Belgium, Spain, the Netherlands, France, Sweden, Iceland, and Denmark. (Also known as: Subfertility)
Clinical trial locations
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Belgium
- Study Comparing Corifollitropin Alfa and Modified Natural Cycles for Women with Subfertility and Low Ovarian Response
- Study Comparing Corifollitropin Alfa and Progestin Primed Ovarian Stimulation for Women with Subfertility Undergoing Elective Fertility Preservation or Genetic Testing
- Study on Subfertility: Comparing Estradiol Valerate and Micronised Progesterone for Frozen-Thawed Embryo Transfer in Women Seeking Pregnancy
- Denmark
- France
- Iceland
- Netherlands
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Spain
- Study on Infertility: Comparing Corifollitropin Alfa and Follitropin Beta for Women Undergoing Elective Fertility Preservation
- Study on Infertility: Effects of Choriogonadotropin Alfa, Nomegestrol Acetate, Estradiol Hemihydrate, and Progesterone in Patients Undergoing Frozen Embryo Transfer
- Study on the Effectiveness of Vaginal Micronized Progesterone for Infertility in Patients Undergoing Assisted Conception with Frozen Embryo Transfer (AC-FET)
- Study on the Effect of Ovarian Stimulation Intensity Using Clomifene Citrate and Follitropin Alfa in Women with Infertility and Suboptimal Response
- Sweden
Study Comparing Corifollitropin Alfa and Modified Natural Cycles for Women with Subfertility and Low Ovarian Response
This trial is designed for women experiencing difficulty conceiving who are expected to have a low response to ovarian stimulation. Participants must be between 18 and 44 years old, with a body mass index between 18.5 and 34.9 kg/m², and have regular menstrual cycles lasting 21 to 35 days. Women must have two ovaries and fall into specific POSEIDON classification groups (Group 3 or 4), which indicate low ovarian reserve based on antral follicle count or anti-Müllerian hormone levels.
The study compares two approaches to assisted reproductive technology. The first uses corifollitropin alfa (Elonva), a long-acting medication that stimulates egg development with a single injection. The second approach involves up to three modified natural cycles with minimal intervention. Additional medications used include ganirelix to prevent premature ovulation, choriogonadotropin alfa to trigger final egg maturation, and follitropin beta for supplementary ovarian stimulation.
The main goal is to determine which approach provides better chances of obtaining at least one good quality blastocyst, an early-stage embryo suitable for transfer. The trial monitors the entire process from medication administration through egg retrieval, embryo development, and transfer, with follow-up to assess pregnancy rates 6 to 8 weeks after embryo transfer.
Study Comparing Corifollitropin Alfa and Progestin Primed Ovarian Stimulation for Women with Subfertility Undergoing Elective Fertility Preservation or Genetic Testing
This trial is open to women aged 18 to 40 years with a body mass index between 18 and 32 kg/m² who need egg freezing for future use or require IVF with genetic testing of embryos. This must be their first ovarian stimulation cycle.
The study compares two different ovarian stimulation methods. One uses corifollitropin alfa (Elonva) combined with progestin primed ovarian stimulation (PPOS), while the other employs conventional stimulation with follitropin beta and a GnRH antagonist. The trial involves two cycles of treatment, allowing researchers to compare patient experiences with both approaches.
Beyond medical outcomes, this study places significant emphasis on quality of life and patient satisfaction. Participants complete questionnaires after each stimulation cycle to assess their experience with the different treatments. The study aims to provide insights into which method offers better outcomes not only in terms of egg retrieval but also regarding patient comfort and overall satisfaction with the treatment process.
Study on Infertility: Comparing Corifollitropin Alfa and Follitropin Beta for Women Undergoing Elective Fertility Preservation
This Spanish trial focuses on women aged 18 to 40 years who wish to preserve their fertility by freezing eggs for future use. Eligible participants must have a body mass index between 18 and 30 kg/m², an antral follicle count of 20 or less, and anti-Müllerian hormone levels of 3 ng/ml or below. These criteria identify women who are good candidates for ovarian stimulation.
The study compares two medication approaches. One group receives two doses of corifollitropin alfa, while the other receives one dose of corifollitropin alfa followed by daily injections of recombinant follicle stimulating hormone (rFSH). Both medications work to stimulate the ovaries to produce multiple mature eggs.
The primary focus is on the number of mature eggs collected, as this directly affects the success of fertility preservation. Secondary outcomes include total egg count, hormone levels on collection day, and any side effects such as ovarian hyperstimulation syndrome. The trial also assesses patient quality of life through questionnaires, recognizing that the treatment experience matters alongside clinical outcomes.
Study on Infertility: Effects of Choriogonadotropin Alfa, Nomegestrol Acetate, Estradiol Hemihydrate, and Progesterone in Patients Undergoing Frozen Embryo Transfer
This trial explores how different medications affect pregnancy outcomes in women undergoing frozen embryo transfer. Participants must be between 18 and 37 years old (or up to 50 years for those using donor eggs), with regular menstrual cycles lasting 24 to 35 days. They must have frozen embryos available from their own eggs and be suitable for single embryo transfer.
The study investigates the role of the corpus luteum, a temporary structure in the ovary that produces hormones supporting early pregnancy. Researchers will examine how its presence affects various aspects of pregnancy, including blood vessel function, placenta development, maternal heart health, and fetal growth. Participants receive one of several medications, including choriogonadotropin alfa, nomegestrol acetate combined with estradiol, or progesterone, or a placebo.
The trial monitors numerous health indicators throughout pregnancy, including hormone levels and cardiovascular function. The goal is to understand whether corpus luteum secretion products influence pregnancy success and maternal-fetal health during frozen embryo transfer cycles, potentially leading to improved treatment protocols in the future.
Study on Progesterone for Improving Birth Rates in Couples with Unexplained Infertility Undergoing Mild Ovarian Stimulation and Intrauterine Insemination
This Dutch trial targets couples diagnosed with unexplained subfertility based on national guidelines, with a Hunault score below 30% indicating low natural conception probability. Women must be between 18 and 43 years old, with a body mass index below 45 kg/m², and have regular menstrual cycles. The male partner must have a total mobile sperm count exceeding 10 million. Participants must be undergoing their first mild ovarian stimulation cycle with intrauterine insemination and willing to continue treatment for at least six months.
The study tests whether adding progesterone support (Utrogestan) during the luteal phase increases the chances of live birth. Progesterone is a hormone crucial for maintaining early pregnancy. Half the participants receive progesterone vaginal capsules, while the other half receive a placebo with identical appearance.
The trial monitors multiple outcomes over six months, including pregnancy rates, live births, miscarriages, and quality of life. It also assesses treatment cost-effectiveness. By comparing progesterone support to no additional support, the study aims to determine whether this simple intervention can significantly improve outcomes for couples with unexplained subfertility undergoing intrauterine insemination.
Study on the Effectiveness of Vaginal Micronized Progesterone for Infertility in Patients Undergoing Assisted Conception with Frozen Embryo Transfer (AC-FET)
This Spanish trial compares two different formulations of vaginal micronized progesterone for luteal phase support during frozen embryo transfer. Participants must be between 18 and 43 years old (or under 50 for donor egg recipients), with a body mass index between 18 and 30 kg/m². They must have previously undergone IVF and be able to attend regular appointments for blood tests and medication collection.
One group receives the standard formulation at 200 mg three times daily, while the other receives a new formulation at 400 mg twice daily. Both medications serve the same purpose: supporting the uterine lining to help embryo implantation and maintain early pregnancy. The reduced dosing frequency of the new formulation may improve patient convenience and compliance.
The study evaluates effectiveness through ongoing pregnancy rates as the primary measure, with secondary outcomes including implantation rates, biochemical and clinical pregnancy rates, miscarriage rates, and adverse events. This comparison helps determine whether the new formulation offers similar or improved effectiveness while potentially being more convenient for patients.
Study on Vaginal Progesterone for Improving Live Birth Rates in Women with Infertility Undergoing Frozen/Thawed IVF Natural Cycles
This trial, conducted in Iceland and Sweden, examines whether vaginal progesterone support improves live birth rates in women undergoing frozen embryo transfer during natural cycles. Participants must be between 18 and 42 years old, with a body mass index between 18.5 and 34.9 kg/m², and have regular menstrual cycles lasting 24 to 35 days. They must understand written and spoken Swedish, English, or Arabic.
The study has two main questions: first, whether providing luteal phase support with vaginal progesterone is better than no support; and second, if beneficial, whether seven weeks of treatment is more effective than three weeks. Participants are randomly assigned to receive either progesterone (Cyclogest 400 mg or Lutinus 100 mg) or placebo.
The primary outcome is live birth, with monitoring throughout pregnancy for various factors including pregnancy progression, complications, and progesterone levels in blood samples. The trial also assesses cost-effectiveness, providing comprehensive data on both clinical and economic aspects of vaginal progesterone support in natural cycle frozen embryo transfers.
Study of fixed-dose follitropin delta for ovarian stimulation in women undergoing intrauterine insemination treatment for infertility
This French trial studies a fixed dose of follitropin delta (Rekovelle) for ovarian stimulation in women undergoing intrauterine insemination. Participants must be between 18 and 38 years old, with a body mass index between 18 and 29 kg/m². They must have normal ovulation cycles, at least one healthy fallopian tube, a normal uterine cavity, and be undergoing their first IUI treatment.
The treatment involves daily subcutaneous injections of follitropin delta at a fixed dose of 3.66 micrograms to stimulate egg production. When follicles reach appropriate size, choriogonadotropin alfa (Ovitrelle) triggers final egg maturation before the insemination procedure. After IUI, participants receive progesterone (Utrogestan) vaginally or dydrogesterone (Duphaston) orally to support potential pregnancy.
The trial allows up to three treatment cycles, with regular monitoring of follicle development through ultrasound and hormone level measurement. Treatment may be adjusted or cancelled if ovarian response is excessive. The study observes how fixed-dose follitropin delta affects ovarian response and pregnancy outcomes in the IUI setting.
Study on Progesterone and Estradiol for Infertility in Patients Undergoing Hormone Replacement Therapy with Frozen Embryo Transfer
This Danish trial investigates rectal administration of progesterone (Cyclogest 400mg) as an alternative to vaginal administration for luteal phase support during frozen embryo transfer. Participants must be between 18 and 46 years old, with a body mass index between 18.5 and 34 kg/m², and have a day 5 frozen blastocyst available for transfer. They must speak and understand Danish.
The study also uses Estrofem (estradiol) tablets taken orally to prepare the uterine lining for embryo transfer. The focus is determining whether rectal progesterone administration is as effective as the traditional vaginal route in supporting pregnancy. This matters because some patients may prefer or better tolerate rectal administration.
Primary outcomes include ongoing pregnancy rates at 12 weeks, with secondary measures including positive pregnancy tests, clinical pregnancy rates, pregnancy loss, live birth rates, and progesterone levels in blood and urine. The trial also assesses convenience and side effects associated with rectal administration, providing comprehensive data on this alternative delivery method.
Study on Progesterone and Estradiol for Infertility in Patients Undergoing Hormone Replacement Therapy with Frozen Embryo Transfer
This second Danish trial on rectal progesterone administration follows similar design to the previous study, examining whether rectally administered Cyclogest 400mg pessaries provide effective luteal phase support during hormone replacement therapy frozen embryo transfer cycles. Participants must meet the same eligibility criteria: age 18-46 years, body mass index 18.5-34 kg/m², availability of a day 5 frozen blastocyst, and Danish language proficiency.
The trial uses Estrofem 2 mg film-coated tablets orally to prepare the endometrium alongside the rectal progesterone. This study design allows researchers to gather additional data on this administration route, potentially confirming findings from the parallel trial and providing more robust evidence for clinical practice.
The comprehensive evaluation includes ongoing pregnancy rates at 12 weeks, positive pregnancy test rates, clinical pregnancy confirmation, pregnancy loss, live births, and hormone measurements. Patient experience with rectal administration is assessed through questionnaires, and any pregnancy complications are monitored. The study continues until late 2026, providing substantial time for data collection and analysis.
Study on the Effect of Ovarian Stimulation Intensity Using Clomifene Citrate and Follitropin Alfa in Women with Infertility and Suboptimal Response
This Spanish trial examines optimal ovarian stimulation intensity for women expected to have suboptimal response to IVF treatment. Participants must be between 35 and 40 years old, with a body mass index between 18.5 and 25 kg/m², an antral follicle count of 5-10, and anti-Müllerian hormone levels of 1.5 ng/ml or below.
The study compares two stimulation protocols combining clomifene citrate (Omifin) with different doses of follitropin alfa (Ovaleap). One group receives 150 IU of follitropin alfa, while the other receives 300 IU. Additional medications include ganirelix (Orgalutran) to prevent premature ovulation, choriogonadotropin alfa (Ovitrelle) to trigger final egg maturation, and progesterone (Utrogestan) for post-transfer support.
The primary focus is embryo quality, specifically the number of good-quality blastocysts obtained. The trial also monitors embryo development timing, including pronuclei appearance, cell division stages, and blastocyst formation rates. This detailed analysis helps determine whether higher stimulation doses improve outcomes in women with diminished ovarian reserve, or whether gentler stimulation yields similar quality with potentially fewer side effects.
Summary
The landscape of clinical trials reflects diverse approaches to addressing different aspects of reproductive challenges. A notable concentration of trials focuses on optimizing progesterone supplementation during frozen embryo transfer, with multiple studies examining administration routes, dosing schedules, and formulations. This emphasis suggests ongoing efforts to refine luteal phase support protocols.
Several trials specifically target women with low ovarian reserve or suboptimal response to stimulation, acknowledging that this population requires tailored treatment approaches. Corifollitropin alfa appears prominently across multiple studies, reflecting interest in long-acting ovarian stimulation medications that reduce injection burden for patients.
Geographic distribution shows particular trial activity in Belgium, Spain, and Denmark, with some studies conducted across multiple countries such as the Iceland-Sweden collaboration. The trials span various fertility treatment types, from intrauterine insemination to advanced IVF techniques, and include both conventional stimulation protocols and more natural approaches.
Quality of life and patient satisfaction feature as secondary outcomes in several trials, indicating recognition that treatment experience matters alongside clinical success rates. The trials collectively aim to improve both pregnancy outcomes and patient experience through medication optimization, protocol refinement, and investigation of novel therapeutic approaches.
