Clinical Research Directory

ActiveGirls: Physical Activity, Hormone Health, and Diabetes Risk in Early Adolescence

This study explores how a physical activity program can affect hormone health and diabetes risk in girls ages 8-12 who may be at higher risk. The study aims to address: * Does the 'ActiveGirls' program meet the needs of girls and families in engaging them to increase physical activity? * What is the trend of markers of diabetes risk and puberty hormones over a 1-year period and how are these levels related to physical activity levels? Participants in this study will either: * Participate in a 'full' intensity intervention that includes educational messages (text/email) as well as health coaching visits to support physical activity over a 6 month period * Participate in a delayed 'lower intensity' intervention that includes only educational messages (text/email) * Participants in both groups will complete at-home activity monitoring, two study visits for check-ups and tests, and surveys

Functional Proteins in Polycystic Ovary Syndrome

The concentration of functional proteins: kisspeptin, ghrelin, zonulin will be measured and compared in women with polycystic ovary syndrome (PCOS) and insulin resistance (IR), in women with PCOS without IR, and in women without PCOS.

Pro- and Anti-inflammatory Cytokines in PCOS

The study will involve measurements and comparisons of the concentrations of pro-inflammatory cytokines: IL-6, TNF-α, IL-18, as well as anti-inflammatory cytokine IL-4 in women with polycystic ovary syndrome (PCOS) and insulin resistance, women with polycystic ovary syndrome without carbohydrate metabolism disorders, and women without PCOS (control group).

Letrozole 5 mg for 10 Days Versus Letrozole 10 mg for 5 Days for Ovarian Stimulation in PCOS

The goal of this clinical trial is to learn if drug letrozole 5mg for 10 days works better than letrozole 10mg for 5 days for ovarian stimulation in infertile women with PCOS. It will also learn about the safety of drug letrozole . The main questions it aims to answer are: What medical problems do participants have when taking drug letrozole? Researchers will compare drug letrozole 5mg for 10 days works better than letrozole 10mg for 5 days for ovarian stimulation in infertile women with PCOS Participants will: The experimental arm (p1) will be treated with letrozole 5 mg for 10 days. The comparator arm (p2) will receive letrozole 10mg for 5 days for ovulation induction for consecutive 3 months Treatment will start from the 2nd day of menstruation cycle or withdrawal bleeding after the baseline visit and investigations. Ovarian response will be assessed by trans-vaginal monitoring of follicle growth aroundday 8 and day 11of menstrual cycle

Feasibility Effects of a Low-GI, High-fibre Diet in PCOS: a Prospective Cohort Study in Remote Yunnan

This study aims to observe the effects of a 6-month, culturally-adapted low glycemic index-high fiber (LGI-HF) dietary on IR, androgen levels, and menstrual regularity among women with PCOS in remote areas of Yunnan Province. We hypothesize that a nutritional strategy designed for high-carbohydrate dietary habits while balancing feasibility and adherence can significantly improve patients' metabolic and reproductive parameters, thereby providing practical evidence-based guidance for long-term PCOS management in resource-limited settings

Endometrial Response in Polycystic Ovarian Syndrome Treated With Letrozole Alone or With Added Estradiol Valerate

Polycystic Ovary Syndrome (PCOS) is one of the most common endocrine disorders among women of reproductive age, characterized by chronic anovulation, hyperandrogenism, and polycystic ovarian morphology. Letrozole, an aromatase inhibitor, has emerged as a first-line ovulation induction agent due to its superior ovulation and pregnancy rates compared to clomiphene citrate. Estradiol valerate, a synthetic estrogen, can be co-administered with letrozole to improve endometrial receptivity by enhancing endometrial thickness, vascularity, and pattern. This study aims to evaluate the effect of letrozole alone versus letrozole with estradiol valerate on endometrial development in these patients.

The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome

This study will look at whether a reduced-calorie Mediterranean-style eating plan, together with a synbiotic supplement, can improve health measures and quality of life in women who have polycystic ovary syndrome (PCOS) and are overweight or have obesity. Participants will be assigned by chance (like flipping a coin) to receive either the synbiotic supplement or a placebo (a look-alike product with no active ingredients). All participants will follow the same reduced-calorie Mediterranean diet for 8 weeks. The study team will measure body composition and weight-related measurements, and will collect blood samples to evaluate selected laboratory markers before and after the 8-week period. Participants will also complete the PCOSQ-50 quality-of-life questionnaire before and after the intervention. The goal is to better understand the possible role of synbiotic supplementation alongside dietary treatment in PCOS.

Treatment of Menstrual Cycle Alterations in Adolescents

the aim of the present study is intended to evaluate how treatment with Myo-Inositol and Dioscorea Villosa can help improve menstrual cycle irregularities in adolescents, both with and without PCOS.

The Physical and Mental Impact of ART: IVM vs Conventional Ovarian Stimulation

Polycystic Ovary Syndrome (PCOS) is one of the most common endocrine conditions, affecting around 10% of women in reproductive age (ESHRE PCOS guideline, 2023). PCOS is a heterogeneous condition characterized by a combination of Polycystic Ovarian Morphology (PCOM) on ultrasound scan, oligo- or amenorrhea and/or hyperandrogenism. Women diagnosed with PCOS are known to have a higher risk for type 2 diabetes mellitus, cardiovascular pathology, pregnancy complications and an impaired quality of life (QoL) (Borghi et al., 2017; ESHRE guideline, 2023). Conventional Ovarian Stimulation (cOS) followed by in vitro fertilization (IVF) or intra cytoplasmic sperm injection (ICSI) is the most frequently used type of ART for PCOS patients. However, women with PCOS often exhibit ovarian hyperresponse to conventional-dose gonadotropin stimulation/cOS, with ovarian hyperstimulation syndrome (OHSS) as the most frequently occurring iatrogenic complication (Vesztergom et al., 2021 ; ESHRE PCOS guideline, 2023). Although, due to a number of strategies to prevent OHSS, the occurrence of severe OHSS has almost been eliminated, with the use of GnRH agonists for final oocyte maturation instead of an hCG trigger as the most efficient strategy, patients might still experience symptoms of abdominal pain and bloating as an indication for mild or moderate OHSS (Bodri et al., 2010 ; Shrem et al., 2019). Aside from the risk for OHSS, patients undergoing cOS, which represents on average a two-week hormonal treatment, may also experience symptoms of hot flushes, breast tenderness, mood swings and higher psychological burden resulting in a reduced QoL during fertility treatment (Barrière et al., 2019; Shrem et al., 2019 ; Adeleye et al., 2020). In view of the aforementioned inconveniences of cOS, In Vitro Maturation of oocytes (IVM) followed by ICSI has been proposed as an alternative treatment option in a PCOS population (Trounson et al., 1994 ; ESHRE PCOS guideline, 2023). In Vitro Maturation has been labeled as a more 'patient-friendly' approach, with the ability to further eliminate the risk for OHSS, minimize cycle monitoring (resulting in less in-hospital visits) and reduced side-effects from hormonal ovarian stimulation (Gilchrist and Smitz, 2023; ESHRE PCOS guideline, 2023 ; Vuong et al., 2023). However, to the best of our knowledge, there is only limited research that investigated the prevalence and types of side-effects and the impact on pain scores and QoL of IVM treatment in PCOS patients (Sanmartin et al., under review; Marchante et al., 2024). Therefore, we set out to investigate the impact of IVM on pain scores, side-effects and QoL during fertility treatment in women diagnosed with severe PCOS. We defined severe PCOS as women with a serum AMH\>10ng/mL because we observed that above this cut-off, cumulative ongoing pregnancy rates were non-inferior after IVM compared to cOS (Mostinckx et al., 2024), with non-inferiority defined as a difference of less than 10% in cumulative ongoing pregnancy rate per cycle. This trial is a single center, superiority, randomized controlled trial that will be conducted at Brussels IVF, UZ Brussel, Belgium in a PCOS population, presenting for their first round of ART at Brussels IVF. Each patient can only participate once in this trial. 64 patients are planned to be enrolled in the trial. 32 patients will be required in the control group (cOS group) and 32 patients in the interventional group (IVM group). Patients will randomly undergo IVM or cOS following randomization. Both treatments will be executed as per treatment as usual (TAU). In both treatment arms, included patients and their partners, will be asked to complete questionnaires at different timepoints after randomization into one of the two treatment arms: * At the time of counseling (T1) * At the end of stimulation (T2) * On the day of oocyte retrieval (T3) * On the day after oocyte retrieval (T4) * At 7 days after oocyte retrieval (T5) * At the end of first embryo transfer cycle (T6) * End of first ART cycle Used questionnaires are two validated questionnaires, FertiQoL and HADS, and a questionnaire developed to investigate side-effects and pain scores after oocyte retrieval.

Letrozole Extended vs Traditional Therapy for Ovulation Induction in Women With PCOS (PROLEx-PCOS)

This randomized clinical trial aims to compare the efficacy and safety of extended letrozole therapy (5 mg/day for 10 days) versus standard letrozole therapy (5 mg/day for 5 days) for ovulation induction in women with polycystic ovary syndrome (PCOS). A total of 84 women aged 18-40 years will be randomized into two groups. Ovulation will be monitored by transvaginal ultrasound and confirmed with urinary LH testing and/or corpus luteum presence. The primary outcome is ovulation rate, while secondary outcomes include number and size of mature follicles, clinical pregnancy rate, multiple pregnancy rate, miscarriage rate, number of cycles until pregnancy, and incidence of ovarian hyperstimulation syndrome (OHSS).

Transcriptomic Profiling of Cumulus Cells From CAPA-IVM

Capacitation in vitro maturation (CAPA-IVM) has improved oocyte maturation and resulted in live births. Because cumulus cells (CCs) communicate bidirectionally with the oocyte, their transcriptomic profile may serve as a non-invasive biomarker of oocyte and embryo competence. This prospective pilot study will analyze CCs gene expression after CAPA-IVM using RNA sequencing and pathway analysis, and correlate findings with embryological outcomes including fertilization, day-3 cleavage, and blastocyst formation. Results are expected to provide insights into the molecular basis of oocyte competence and support development of non-invasive embryo selection strategies.

Symptoms of Polycystic Ovarian Syndrome Ameliorated by Keto-Adaptation Pilot

The SPARK- Pilot study (Symptoms of PCOS Ameliorated by Responses to Keto-adaptation) is a 12-week clinical trial at The Ohio State University designed to explore how different ways of achieving ketosis may improve reproductive and metabolic health in women with Polycystic Ovary Syndrome (PCOS). Participants will be randomly assigned to one of two groups: * A ketogenic diet group, following a low-carbohydrate, nutrient-dense meal plan. * A mixed diet plus ketone supplement group, following general dietary guidelines while taking an exogenous ketone supplement. The study will measure whether these approaches help restore regular ovulation and improve hormone balance, metabolism, and overall well-being. Optional imaging using MRI will also examine heart and ovarian health. This pilot study will help researchers understand if ketogenic nutrition strategies are a safe, effective way to support menstrual regularity and reduce PCOS-related symptoms, providing groundwork for larger clinical trials.

Effect of Omega-3 Supplementation as Add on Therapy on Metabolic Syndrome in Women With Polycystic Ovary Syndrome.

The goal of this clinical trial is to learn if Omega-3 works to treat Polycystic ovary syndrome in women. It will also learn about the safety of drug Omega-3. The main questions it aims to answer are: Does Omega-3 lower the number of times participant to treat metabolic syndrome What medical problems do participants have when taking drug Omega-3.Researchers will compare drug Omega-3 to a placebo (a look-alike substance that contains no drug) to see if drug Omega-3 used to treat PCOS. Participants will: Take Omega-3 or a placebo every day for 3 months Visit the clinic once every 6 weeks for checkups and tests Keep a diary of their symptoms and menstrual history.

In Vitro Maturation of Human Eggs

CCRM Fertility, a global pioneer in fertility treatment, research and science, is seeking participants for a new study on in vitro maturation (IVM). IVM requires less hormones to stimulate the ovaries than IVF, making it more affordable than IVF with fewer side effects. Participants that qualify for the study will receive a free cycle of IVM treatment at CCRM Fertility and including a new patient consultation, fertility testing, preimplantation genetic testing for aneuploidies (PGT-A), anesthesia and some medication