Ongoing Clinical Trials for Diminished Ovarian Reserve
Four clinical trials are currently investigating new treatments for women with diminished ovarian reserve, a condition that reduces the ovaries’ ability to produce eggs and affects fertility. These studies are testing different approaches including hormone treatments and blood-derived therapies to improve outcomes for women undergoing fertility treatments such as IVF and ICSI. Trials are taking place in Denmark and Spain.
Clinical trial locations
- Denmark
- Spain
- Study of Platelet-Rich Plasma and Growth Factors Given by Ovarian Injection to Women with Low Ovarian Reserve During IVF Treatment
- Study on the Safety and Effectiveness of Platelet Concentrate for Women with Low Ovarian Reserve
- Study of testosterone gel treatment for women with low ovarian reserve and androgen receptor polymorphism undergoing fertility treatment
Study on the Effects of Low Dose Choriogonadotropin Alfa in Women with Diminished Ovarian Reserve Undergoing IVF/ICSI
This trial, taking place in Denmark, is testing whether low-dose hormone treatment can help women with reduced egg supply produce more eggs during fertility treatment. The study focuses on understanding if an eight-week course of treatment before IVF or ICSI procedures can improve outcomes.
Who can participate: Women between 18 and 40 years old who have regular menstrual cycles lasting between 23 and 35 days are eligible. Participants must be undergoing their 1st to 5th IVF or ICSI cycle and have an AMH level (a hormone that indicates egg supply) below 6.29 pmol/L. This hormone measurement helps doctors understand how many eggs a woman has available.
Who cannot participate: The study excludes women who do not have fertility problems or who have normal ovarian reserve. Men cannot participate, and women outside the specified age range or who belong to vulnerable populations requiring special protection are also excluded.
What the study involves: Participants receive injections of a medication called Ovitrelle, which contains choriogonadotropin alfa, a hormone commonly used in fertility treatments. The medication is given as a subcutaneous injection, meaning it is injected just under the skin. The treatment continues for eight weeks before the IVF or ICSI procedure begins. Throughout the trial, doctors will monitor how participants respond by measuring hormone levels, counting follicles in the ovaries, and ultimately counting how many eggs can be retrieved during the fertility procedure.
Treatment being tested: The main medication is hCG, a hormone that mimics another hormone in the body called luteinizing hormone. By using this hormone in low doses over several weeks, researchers hope to stimulate the ovaries to produce more eggs, potentially improving the chances of successful pregnancy for women with reduced egg supply.
Study on the Safety and Effectiveness of Platelet Concentrate for Women with Low Ovarian Reserve
This Spanish trial explores whether injecting a special blood-based treatment directly into the ovaries can improve their function. The treatment uses plasma rich in growth factors, which are natural proteins in blood that help with healing and tissue regeneration.
Who can participate: Women classified in specific categories of low ovarian reserve can join this study. This includes women under 35 with an AMH level below 1.2 ng/ml and fewer than 5 antral follicles, as well as women 35 years or older with the same measurements. Participants must have at least one ovary, have been trying to conceive unsuccessfully for at least one year, and have ovaries that can be safely accessed during the procedure. Written consent is required.
Who cannot participate: Men cannot participate in this female-only study. Women who fall outside the specified age range or who belong to vulnerable populations are excluded.
What the study involves: After joining the study and meeting all requirements, participants undergo an initial assessment measuring various hormones including FSH, LH, estradiol, and AMH. They also have their antral follicle count measured. The treatment consists of an injection of plasma rich in growth factors directly into the ovaries. Following treatment, participants undergo follow-up assessments to compare their ovarian function before and after the injection. If they proceed with IVF or ICSI, researchers will monitor how many eggs are retrieved, how many are fertilized, and the quality of resulting embryos. The study will also track pregnancy rates and any complications.
Treatment being tested: The therapy uses a patient’s own blood, processed to concentrate growth factors and platelets. These natural healing proteins are injected into the ovaries with the goal of stimulating ovarian cells and potentially improving their function, which may lead to better fertility outcomes.
Study of Platelet-Rich Plasma and Growth Factors Given by Ovarian Injection to Women with Low Ovarian Reserve During IVF Treatment
This Spanish study compares platelet-rich plasma treatment with a placebo to determine if it can increase the number of eggs collected during IVF treatment. The research focuses specifically on women whose ovaries produce fewer eggs than expected.
Who can participate: Women diagnosed with low ovarian response, aged between 18 and 42 years, with regular menstrual cycles occurring every 24 to 35 days are eligible. Participants must be undergoing a single IVF cycle without storing extra eggs or embryos. Both partners need normal chromosome structures, and recent blood work must show adequate platelet counts (above 160,000/mcL) and negative tests for HIV, hepatitis B, hepatitis C, and syphilis. The male partner must have a sperm count above 5 million motile sperm, or sperm donation must be used. Both ovaries must be accessible through vaginal ultrasound, and participants must have a BMI above 18.
Who cannot participate: Women under 18 or over 40 years old cannot participate. The study excludes pregnant or breastfeeding women, those with allergies to blood products, active infections, previous ovarian surgery, ovarian cysts larger than 3 cm, or uncontrolled medical conditions like diabetes. Women with a BMI over 35, more than three previous unsuccessful IVF attempts, active substance abuse or smoking, mental health conditions affecting study participation, or recent participation in other trials are also excluded.
What the study involves: Participants are randomly assigned to receive either the platelet-rich plasma treatment or a placebo consisting of salt water. The treatment is administered through a single injection directly into both ovaries using a vaginal approach. Following the injection, participants undergo one IVF cycle, and researchers count the number of eggs retrieved. The study continues until April 2027.
Treatment being tested: PRFG-Endoret is a specialized preparation made from the patient’s own blood, containing concentrated platelets and growth factors. These components are believed to stimulate and regenerate ovarian tissue, potentially improving egg production during fertility treatments.
Study of testosterone gel treatment for women with low ovarian reserve and androgen receptor polymorphism undergoing fertility treatment
This Spanish trial investigates whether testosterone gel applied to the skin before fertility treatment can help women with both low ovarian reserve and a specific genetic variation produce more eggs. The study combines testosterone pretreatment with standard fertility medications.
Who can participate: Women must meet at least two of the following criteria: be 40 years or older, have had a previous fertility treatment with fewer than 4 eggs retrieved, or have low ovarian reserve test results (antral follicle count less than 5-7 or AMH less than 0.5-1.1 ng/ml). Additionally, participants must have a specific genetic variation in their androgen receptor (between 22 and 24 CAG repeats), a BMI below 32, both ovaries present without cysts, no endometriosis, normal chromosome and fragile X testing, and sperm available from ejaculation. They must be able to follow study requirements and provide written consent.
Who cannot participate: Women below 18 or above 40 years old, men, those who don’t meet the medical criteria for low ovarian reserve or don’t carry the specific genetic variation, participants in other trials, pregnant or breastfeeding women, those with medical reasons making testosterone unsafe, known allergies to study medications, severe medical conditions, inability to provide consent, history of bad reactions to hormone treatments, or conditions affecting hormone processing are excluded.
What the study involves: Treatment begins with daily application of Testogel, a testosterone gel applied to the skin. After this pretreatment phase, participants receive daily injections of Decapeptyl (0.1 mg) under the skin, followed by Bemfola injections (starting at 300 IU) to stimulate egg follicle development. Astarté injections (0.25 mg) are given to prevent premature egg release. Once follicles reach the appropriate size, eggs are collected and evaluated. The collected eggs then undergo ICSI, where a single sperm is injected directly into each mature egg. Researchers monitor fertilization and embryo development.
Treatment being tested: Transdermal testosterone is a hormone medication applied through the skin that increases testosterone levels in the body. In this trial, it serves as a pretreatment aimed at potentially improving the number of eggs that can be retrieved during fertility procedures by stimulating ovarian follicle development.
Summary
These four clinical trials represent different approaches to addressing fertility challenges in women with reduced ovarian reserve. Three of the four studies are taking place in Spain, with one in Denmark, suggesting a concentration of research activity in Southern Europe on this condition.
The trials explore diverse treatment strategies: hormone-based approaches using hCG and testosterone, and regenerative medicine techniques using platelet-rich plasma and growth factors derived from the patient’s own blood. Two of the Spanish trials focus specifically on platelet-rich plasma injections directly into the ovaries, reflecting growing interest in this innovative approach.
All studies share the common goal of increasing the number and quality of eggs available during fertility treatments like IVF and ICSI. The trials vary in their eligibility criteria, with age ranges spanning from 18 to 42 years depending on the study, and each has specific requirements regarding hormone levels and ovarian measurements. Women interested in participating should carefully review the inclusion criteria for each trial, as some require specific genetic variations or particular classifications of low ovarian reserve.
