Premature Ovarian Insufficiency

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.

Premature ovarian insufficiency (POI) occurs when ovarian function declines in women before age 40, significantly affecting health and quality of life. This research aims to better understand the causes, progression, and health impacts of POI, as well as evaluate hormone replacement therapy (HRT) options. The study will create a hospital-based, multi-center case-control and prospective cohort to gather comprehensive data on POI's natural course and effects. The study includes several groups: women diagnosed with POI, control women with regular menstrual cycles, those scheduled for ovarian surgery, and those undergoing oophorectomy. Participants provide biological samples, lifestyle and health information, and undergo long-term follow-up assessments. Data collection spans multiple health factors including reproductive hormones, bone density, psychological well-being, and metabolic markers. Participants will be monitored at regular intervals up to 36 months with tests such as bone density scans, hormone level checks, blood glucose and insulin measurements, and psychological assessments for anxiety and depression. The study also tracks symptoms related to low estrogen and sexual health. Safety and health outcomes are observed through blood counts, liver and kidney function tests, and ultrasound exams. This comprehensive approach aims to deepen understanding and support improved care for women with POI.

Researchers are evaluating the efficacy and safety of the Bushen Yiqi formula combined with dehydroepiandrosterone (DHEA) in treating women with diminished ovarian reserve (DOR). This study aims to determine whether this combined therapy can improve ovarian reserve, hormone levels, ovarian follicle characteristics, and clinical symptoms, while also assessing potential safety concerns. The trial compares the combined treatment to DHEA plus a placebo to see if the combination offers better results. Participants will be randomly assigned to one of two groups: one receiving DHEA combined with the Bushen Yiqi formula and the other receiving DHEA with a placebo. Both treatments are given orally for 12 weeks. The Bushen Yiqi formula is a granulated herbal mixture taken twice daily, while DHEA tablets are taken three times daily. The placebo is designed to look and taste like the herbal formula to maintain blinding. During the study, participants will undergo regular clinical assessments including measurement of ovarian reserve markers like AMH and antral follicle count, sex hormone levels (FSH, LH, E2, testosterone), traditional Chinese medicine symptom scores, menopausal index scores, inflammatory markers (CRP and IL-6), and safety evaluations. Blood samples for AMH will be collected at specific menstrual cycle days before treatment, after treatment, and after a 3-month follow-up. The total participation period includes treatment and follow-up assessments to monitor outcomes and safety.

Researchers are evaluating and comparing the immune modulation effects of three FDA-approved CDK4/6 inhibitors—palbociclib, ribociclib, and abemaciclib—combined with letrozole as neoadjuvant treatment for early estrogen-receptor positive (ER+)/HER2-negative breast cancer. While all three inhibitors have shown progression-free survival benefits in advanced breast cancer, differences in overall survival might be influenced by their varying effects on the tumor microenvironment and immune system. This Phase 2 randomized study aims to provide a head-to-head comparison of these effects in the same trial. Participants will receive one of three treatment combinations: palbociclib with letrozole, ribociclib with letrozole, or abemaciclib with letrozole. These CDK4/6 inhibitors are given alongside endocrine therapy before surgery over a 12-week period. Tissue, blood, and stool samples will be collected before treatment, two weeks after starting treatment, and after 12 weeks at surgery to analyze immune-related changes through RNA sequencing of breast tumors. During the study, researchers will monitor participants for immune response changes and adverse events. The primary outcome is the change in immune-related gene expression after treatment, assessed through RNA sequencing over an average follow-up of three years. Safety will be assessed over four months. Participants’ organ function and performance status will be evaluated before and during treatment to ensure safety and compliance with study procedures.

Non-combat-related muscle, tendon, and bone injuries are common among military personnel, especially new recruits, affecting readiness and causing significant medical costs. This research investigates how hormonal changes, specifically sex hormones like testosterone and estrogen, influence muscle, tendon, and bone function as well as physical and psychological performance under stress. The study aims to improve military physical training and reduce injuries by understanding these hormonal effects. Participants will be assigned to different groups including a control group maintaining normal habits and a stress exposure group undergoing a 4-week military-style physical training program. Some men and women in the stress group will receive medications to suppress natural hormone production and then receive hormone replacement or a placebo. Treatments include a GnRH agonist injection and topical testosterone gels or estrogen/progesterone patches, with dosing varying by group and sex. Throughout the approximately 8-week study, participants will undergo measurements such as muscle and tendon imaging, body composition analysis, blood tests for hormone and biochemical markers, and physical and mental performance evaluations. Researchers will monitor changes in these outcomes over time to assess the effects of hormone suppression and replacement on musculoskeletal resilience and adaptation to stress.

Researchers are evaluating the combination of adebrelimab and fuzuloparib in people with recurrent platinum-resistant ovarian cancer who have not received previous systemic antitumor therapy for this cancer. This exploratory, single-arm Phase 2 study focuses on assessing the effectiveness and safety of this drug combination in women with this condition. The study is led by Fujian Cancer Hospital and aims to measure outcomes over a 3-year period. Participants receive adebrelimab at 20 mg/kg intravenously every three weeks and take fuzuloparib orally at 100 mg twice daily. The study does not include a comparator group and follows a single treatment approach. Treatment continues under medical supervision while researchers monitor the participants' response and safety. During the study, participants undergo regular evaluations including scans to measure tumor response using RECIST1.1 criteria, blood tests, and physical assessments. Researchers track the primary outcome of objective response rate over three years, along with secondary outcomes like overall survival, progression-free survival, and disease control rate. Safety monitoring and adherence to study procedures are maintained throughout the study, with participation lasting up to three years.

Researchers are studying infertility in men and women to improve assisted reproductive techniques using artificial intelligence (AI). The study focuses on key factors affecting in vitro fertilization (IVF) success, such as the age of the woman, oocyte quality, maturation state, and sperm quality. AI will analyze a sequence of data starting with imaging the meiotic spindle in the oocyte, followed by paternal factors and early embryo development to predict embryo ploidy and pregnancy success. This approach aims to increase treatment efficiency and reduce costs by selecting the most promising candidates and minimizing the need for expensive laboratory tests. The intervention involves applying AI to automatically analyze microscopic images of oocytes and time-lapse videos of embryo development after intracytoplasmic sperm injection (ICSI). The study uses image analysis and machine learning to assess the meiotic spindle and other oocyte features that may correlate with fertilization, pregnancy success, or genetic defects. Collaboration with technical and scientific institutes aims to develop software capable of predicting pregnancy probability and embryo ploidy status from these images and videos. Participants will undergo procedures including ICSI, preimplantation genetic testing, and time-lapse embryo recording. Data collected will be paired with pregnancy outcomes and embryo ploidy status. Researchers will evaluate sperm parameters in relation to fertilization and early embryo development. The primary outcome measured is the accuracy of AI in predicting embryo ploidy. The study involves detailed image and video analysis but does not involve treatment randomization. Participants' involvement will include consent, image recording, and genetic testing, with the study expected to continue through March 2028.

Researchers are studying how changes in the gut microbiome relate to hormonal changes during women's ageing, especially throughout menopause. This observational study focuses on healthy women aged 40 to 64 living in Portugal. It aims to understand how menopause affects long-term health by examining gut microbiome, hormone levels, and markers of chronic low-grade inflammation, to help develop better prevention strategies for women's health. Participants are grouped by menopausal stage: premenopausal with regular periods, perimenopausal with irregular periods and some menopausal symptoms, and menopausal/postmenopausal with no menstruation for 12 months. Women will provide stool and blood samples and complete questionnaires about their health, lifestyle, diet, and menopausal symptoms. The study collects data over 10 years, with baseline and follow-up assessments every two years. During the study, participants will be assessed for gut microbiome composition and function, hormone levels, inflammation markers, menopause-related symptoms, nutrition, physical activity, sleep habits, and stress levels. These evaluations help researchers identify microbiome and blood biomarkers linked to menopause and ageing. Participation involves regular sample collection and questionnaires, with ongoing monitoring to support personalized risk assessment and prevention in women's health.

Researchers are collecting Real-World Data (RWD) to study the ongoing safety and effectiveness of the anovo Surgical System during transvaginal gynecological laparoscopic surgeries. They are also evaluating how the anovo Skills Development Pathway affects surgeon behavior and performance, focusing on the learning curve and procedure outcomes across surgeons with different experience levels. The study aims to minimize bias by including a broad patient population. The study involves surgeons using the anovo Surgical System, an endoscopic instrument control device designed to assist in controlling instrument arms during single site, natural orifice laparoscopic-assisted transvaginal benign gynecological surgeries. The study collects data on surgery times and adverse device events, while tracking surgeon competency development through the Skills Development Pathway. Participants will be patients undergoing gynecological surgery with the anovo Surgical System. Researchers will collect data on conversion rates to other surgical approaches and monitor for unanticipated adverse device effects up to 8 weeks post-surgery. Patients will also complete post-operative questionnaires to provide additional information. This observational registry study provides ongoing safety and performance data to understand device use in real-world settings.