Infertility

Researchers are studying the effects of the drug leflutrozole on semen quality in men aged 18 to 49 years with low testosterone levels. This phase 2 clinical trial aims to find out whether leflutrozole can improve semen quality and what side effects participants may experience compared to a placebo. The trial is sponsored by ReproNovo Aps and focuses on testicular function and hormone levels. Participants will be randomly assigned to receive one of three doses of leflutrozole (0.05 mg, 0.1 mg, or 0.3 mg) or a placebo. The medication is taken orally once a week for 16 weeks. The study is double-blind, meaning neither the participants nor the researchers know who receives the drug or placebo. Checkups and tests occur every 4 weeks during the treatment period. Men in the trial will provide semen samples to measure sperm count, motility, and other quality markers. Blood tests will monitor hormone levels such as testosterone and estradiol, as well as safety markers including prostate-specific antigen and ECG readings. Questionnaires will assess changes in libido and energy. Researchers will track adverse events throughout the 16 weeks to evaluate safety and effectiveness.

This research aims to compare the pharmacokinetics of SJ04, a biosimilar of Ovidrel4, in healthy Chinese female subjects aged 20 to 40 years. The study evaluates how similar the body processes these two recombinant human chorionic gonadotropin injections when given by subcutaneous injection. It is a randomized, open-label, single-dose, two-cycle, double-crossover trial involving healthy women to assess drug similarity and safety. Participants are randomly assigned to two groups: one receives SJ04 first followed by Ovidrel4 after a two-week washout period, and the other receives Ovidrel4 first followed by SJ04 after the same interval. Each injection is a single subcutaneous dose of 250 1g given once per cycle. The crossover design allows each subject to receive both treatments with a washout period in between. During the study, researchers monitor pharmacokinetic measures such as the area under the plasma concentration curve and peak plasma concentration on day 8 after dosing. They also track adverse events and immune responses. The trial involves screening, drug administration on specified days, and follow-up assessments to evaluate safety and drug behavior. Participation lasts through both cycles including the washout and observation periods.

This research aims to evaluate a gender-transformative intervention designed to reduce intimate partner violence (IPV) against infertile women. It focuses on couples diagnosed with female-factor infertility undergoing their first or second IVF or ICSI cycle. The trial addresses the overlap between infertility and IPV, recognizing that infertile women face higher risks of IPV and that their needs have often been overlooked. Participants are randomly assigned to one of two groups. The intervention group receives five 60-minute sessions led by trained nurses and social workers throughout the fertility treatment cycle. These sessions cover gender norms, gender equality, and healthy relationship skills at key treatment stages: before the cycle starts, during follicular monitoring, before oocyte retrieval, two weeks after embryo transfer, and 28-30 days post-transfer. The control group receives standard reproductive care. A total of 376 couples will participate, split evenly between the two groups. During the study, couples will undergo assessments at baseline and multiple points up to about 14 months after delivery. Researchers will measure the rate of IPV against infertile women over the past 12 months as the primary outcome. Secondary assessments include IPV against male partners, attitudes toward gender roles, marital quality, coping with stress, patient satisfaction with treatment, pregnancy outcomes, and neonatal health. This comprehensive follow-up includes questionnaires, clinical pregnancy tests, and monitoring of birth outcomes to understand the intervention's impact over time.

Young adults aged 25 to 39 who have cancer face unique challenges in coping, and their partners who provide care may feel burdened and less confident in their caregiving roles. Researchers are evaluating a brief psychotherapy intervention designed to improve how these young adults and their caregiving partners cope with cancer and maintain their relationships. This pilot study aims to test whether this intervention is feasible and acceptable in this specific group, providing important information for future larger studies. The intervention involves eight weekly virtual psychotherapy sessions lasting 45 to 60 minutes, delivered to young adults with cancer and their self-identified partners together. It is based on cognitive-behavioral therapy and couples-focused therapy principles tailored for young adults. A trained mental health practitioner will guide the sessions, which include teaching, practical exercises, and home practice. The study includes 10 young adults with cancer and their caregiving partners, totaling 20 participants. Participants will complete surveys before starting the intervention and again after finishing the eight sessions to measure feasibility and acceptability over approximately 14 weeks. They will also be invited to take part in optional interviews to share their experiences. This study is sponsored by Massachusetts General Hospital and does not include a control group or blinding. The total duration of involvement for participants is about three and a half months.

This research aims to compare two oxygen concentration protocols—constant 5% versus sequential 5%-2%—used during embryo culture in assisted reproductive technology. The study focuses on women undergoing blastocyst transplantation to evaluate differences in term live birth rates and offspring health, including potential effects on telomere length, which is linked to aging and health outcomes. The trial is conducted across five centers, including the Clinical Center of Reproductive Medicine at the First Affiliated Hospital of Nanjing Medical University. Participants are randomly assigned to one of two groups: one receives embryo culture under a constant 5% oxygen concentration, and the other under a sequential protocol reducing from 5% to 2%. Both groups follow their respective blastocyst culture protocols during in vitro fertilization or intracytoplasmic sperm injection cycles. The study monitors outcomes related to live births and health status of offspring associated with each oxygen protocol. Women enrolled in the trial will be followed for three years, during which live birth rates, clinical pregnancy rates, implantation rates, miscarriage rates, and ectopic pregnancy rates will be recorded. Researchers will also assess offspring health by measuring peripheral blood telomere length. Evaluations include monitoring pregnancy outcomes and any perinatal complications. Data will be statistically analyzed to determine the effects of oxygen concentration protocols on reproductive success and offspring well-being.

Chronic subdural hematoma (CSDH) is a common condition often treated by neurosurgical evacuation and drainage of the hematoma. This research aims to compare two drainage methods after surgery: 24 hours of active subperiosteal drainage versus 24 hours of passive subdural drainage. The study is a nationwide, randomized clinical trial conducted across all neurosurgical units in Denmark to evaluate if active drainage is not worse than passive drainage in terms of safety and recurrence. Participants will be adults with symptomatic unilateral CSDH undergoing single burr hole evacuation. Before surgery, patients will be randomly assigned to receive either 24 hours of active subperiosteal drainage or 24 hours of passive subdural drainage. Both drainage methods are already in use, but a direct comparison has not been done. The trial will monitor patients for 90 days post-surgery to assess outcomes. During the study, participants will be evaluated for mortality and recurrence of CSDH requiring reoperation within 90 days. Other assessments include complications related to surgery, length of hospital stay, and functional outcomes measured by the simplified modified Rankin scale. The study uses a double-blind design for patients and statisticians and plans to enroll 354 participants over approximately two years.

Researchers are exploring a new non-invasive method to select embryos during assisted reproductive technology treatments such as IVF and ICSI. This study evaluates an integrated approach combining artificial intelligence-enhanced morphokinetic (MK) analysis using time-lapse imaging and Raman spectroscopy (RS) of the spent culture medium to improve embryo assessment. The goal is to increase the clinical pregnancy rate by accurately identifying embryos with chromosomal abnormalities without the need for invasive genetic testing. The study has two phases. Phase I is a retrospective study collecting data to train the AI model combining MK and RS methods. Phase II is a prospective randomized controlled trial where participants are assigned to one of two groups: embryos selected by the MK-RS integrated method or embryos selected by traditional morphological assessment by embryologists. Embryo images are captured every 10 minutes, and spent culture medium is analyzed by RS to detect metabolic markers. The MK-RS method aims to complete embryo assessment within 5-6 days after fertilization. Participants will undergo IVF/ICSI treatment with embryo culture using a time-lapse incubator. Researchers will collect images and culture medium samples to analyze embryo development and metabolic profiles. The main outcome measured is the clinical pregnancy rate at 6-8 weeks of gestation. Secondary outcomes include miscarriage rate, multiple pregnancy rate, ploidy status, and live birth rate. The study involves monitoring embryo development, collecting biological samples, and evaluating pregnancy outcomes through follow-up.

Researchers are evaluating the effects of vipoglanstat on non-menstrual pelvic pain (NMPP) related to endometriosis in women aged 18 to 44 years. This Phase 2 trial aims to assess how well vipoglanstat works and its safety in treating moderate to severe pain caused by endometriosis. The study is sponsored by Gesynta Pharma AB and is designed as a randomized, double-blind, placebo-controlled trial.

Researchers are evaluating changes in bone mineral density in premenopausal women with heavy menstrual bleeding caused by uterine fibroids or moderate-to-severe pain from endometriosis. This Phase 3B, open-label study looks at the effects of continuous treatment with a relugolix combination tablet for up to 48 months (4 years), followed by a 1-year period to monitor bone health after stopping treatment. Participants will take a daily oral relugolix combination tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg for 4 years. Bone mineral density will be measured every 6 months using dual-energy X-ray absorptiometry (DXA). Some women who have completed a previous related study may join to complete 3 years of treatment. After treatment ends, bone density will be checked again at 6 months and 12 months during the follow-up year. Women in the study will have regular visits for bone density scans and health assessments, including physical and gynecological exams, lab tests, and vital signs. Researchers will track changes in bone density at the spine, hip, and femoral neck throughout treatment and follow-up. They will also monitor for any fractures or adverse events during the 4 years of treatment and the 1-year post-treatment period. Total participation can last up to 5 years including the follow-up.

Researchers are studying how serum kisspeptin levels change throughout pregnancy in women with polycystic ovary syndrome (PCOS). This study aims to understand the relationship between kisspeptin, insulin, glucose, and testosterone levels, and to explore whether kisspeptin can predict gestational diabetes mellitus (GDM) and other pregnancy complications in PCOS patients. The study is observational and focuses on pregnancies affected by PCOS using the 2003 Rotterdam diagnostic criteria. The study includes two groups: pregnant women aged 18 to 40 diagnosed with PCOS before pregnancy, and healthy pregnant women in the same age range without PCOS. Participants will be registered for prenatal check-ups during the first trimester. This is an observational study, so no specific treatments or interventions will be given. Researchers will monitor kisspeptin and related hormone levels at different stages of pregnancy. Participants will be followed throughout pregnancy, with assessments to measure dynamic changes in serum kisspeptin over 40 weeks. The study will also evaluate how kisspeptin levels relate to the development of GDM and insulin resistance. Participants will undergo regular check-ups, laboratory tests, and hormone measurements. The study will help understand hormonal changes in PCOS pregnancies and their potential impact on complications, with a total participation time covering the full pregnancy period.