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Showing 1-20 of 306 trials
NCT07622420
In the past two decades, the evidence-based knowledge on the prevalence and risk factors for gonads impairment, including infertility, following cancer and numerous cancer treatment regimen has significantly increased. However, data remains mostly insufficient for individualized prediction of (future) fertility and pregnancy potential, including the use and success of artificial reproductive technologies (ART). Furthermore, therapies have become increasingly complex as more recent treatment regimen have continuously also implemented novel treatment approaches (e.g. immune therapies such as checkpoint inhibitors) for which no comprehensive data regarding its impact on fertility and pregnancy outcomes is available, yet. It is crucial to carefully balance risk-benefit between fertility preservation (FP) procedures and potential of gonadal function/fertility impairment, to examine the efficiency and safety, as well as to assess patients' satisfaction regarding the FP procedures. Answering these questionsis highly relevant as it has been shown that fertility capacity and post-treatment gonadal function may represent a significant part of quality of life in young cancer survivors. The study therefore aim to set up a large-scale registry of emerging data collection programmes to evaluate the gonadotoxic risks, including the prevalence and course of ovarian dysfunction and/or fertility impairment and premature ovarian insufficiency following specific treatments, identification of further risk factors and predictive markers to enhance precision survivorship research in this field. Additionally, data on the use of fertility preservation/hormonal treatment and patients' satisfaction related to these procedures in Europe will be analysed to support patient-centric care. Reproductive health counselling should not be limited to evaluating the risk of gonadotoxicity and offering fertility preservation to those at risk. It should also include evaluating the impact on post-treatment sexuality, menopausal symptoms management, and the counselling on contraception. In addition to clinical information, whole genome sequence data will be generated for selected study participants with evidence of varying impact of gonadotoxic therapies on reproductive function to find genetic variants associated with risk of reproductive and organ toxicity. The data collection will focus on all different cancer diseases, including diseases which are less common such as different types of sarcomas. This will be a significant development to the current state of information in existing registries. The primary objectives of this prospective analysis of European ongoing adolescent and young adult (AYA) cancer patient cohorts are: 1. To establish a database with relevant clinical characteristics at time of diagnosis, cancer therapy received and post-cancer clinical and reproductive outcomes by following AYA cancer patients longitudinally. 2. To evaluate the effect of cancer therapies on ovarian function and reproductive potential. 3. To evaluate fertility preservation measures performed, their risks and efficacy. 4. To evaluate the impact of fertility preservation measures on the risk of cancer relapse. 5. To evaluate occurrence of pregnancies/live births naturally conceived (including unplanned) or through medical assistance post-cancer and the obstetrical complications and neonatal health following the use of cryopreserved oocytes or gonadal tissue. 6. To set up a genetic database based on whole genome sequencing of AYAs of the cohort. For this objective a Substudy 1 : " Development of risk prediction models based on clinical and genetic data " will be conducted. 7. To develop prediction models for organ toxicities in cancer patients (objective included in Substudy 1). 8. To evaluate the effect of cancer therapies on sexuality and quality of life. For this objective a Substudy 2 : "Sexual Health" will be conducted. 9. To evaluate the use and counselling on contraception. For this objective, a Substudy 3 : "Contraception" will be conducted. 10. To describe management of treatment-induced premature ovarian insufficiency (POI) and menopausal symptoms. For this objective a Substudy 4 "Management of POI and Menopause Symptoms" will be conducted. 11. To explore patient's satisfaction receiving counseling and/or undergoing fertility preservation. For this objective a Substudy 5 on "Satisfaction with Fertility Preservation" will be conducted.
NCT02882191
To evaluate the effectiveness, device placement, safety, and tolerability of LevoCept to support commencing a Phase III Clinical Study
NCT04828824
To compare rates of etonogestrel implant discontinuation in implant initiators who are given advance provision of combined oral contraceptive pills (COCs) and a bleeding rescue regimen (COCR intervention) to participants given standard counseling (comparator).
NCT07547696
The purpose of this study is to identify the best combination of new intervention components to use with CARRII, the first automated online intervention for alcohol-exposed pregnancies (AEP). This intervention is specifically designed for Native women and others who can become pregnant. Our goal is to maximize the effectiveness of the online intervention while keeping costs manageable for Native communities.
NCT02146950
This study is designed to investigate whether LCS12 is associated with an increased risk of unintended pregnancy compared to Mirena and to copper IUDs. The objective is to assess among new users the risks of certain events (e.g. contraceptive failure rate, ectopic pregnancy, uterine perforation, and PID) associated with the use of LCS12 compared with the established hormonal IUD Mirena, and compared with established copper IUDs during standard clinical practice. In addition, drug utilization patterns will be described.
NCT06019533
Multicentre, single arm phase III trial to assess the pearl index of LVDS. The trial lasts 13 cycles.The assessments include (but are not limited to) recording demographic data, pregnancy tests, gynaecological examinations, laboratory tests and a quality of life questionnaire. Adolescents will undergo DXA scans to measure bone mineral density (at selected sites only). The women will be provided with an e-diary app for their smartphone, to record IP use and vaginal bleeding.
NCT02076217
This project will quantify rates of contraceptive failure when unprotected intercourse occurs 6-14 days prior to initiation of highly effective reversible contraceptives (such as IUD's and Implants).
NCT04007614
Many factors are known to influence the acquisition of bone capital, especially estrogens in women. Estrogens have a major role in bone growth and the acquisition of bone mass peaks during puberty. This peak of bone mass is an important determinant of the risk of osteoporotic fracture in adulthood. It is known that estrogen deficiency increases the rate of bone remodeling and engenders an imbalance between resorption and bone formation, which can lead to osteoporosis. Oral estroprogestin contraceptives have an anti-gonadotropic effect and suppress estrogen secretion by the ovaries. However, studies in adolescents and young adults are rare and evidence of an effect on bone is still inconclusive, although there is increasing evidence that oral estroprogestin contraceptives in teenage girls may compromise the performance of the bone mass. Macro progestins treatments are prescribed in France to patients with contraindications to estroprogestin treatments. This practice is french and few recommendations exist on the use of these molecules by the oral route. There are no studies that describe the impact of these oral treatments on the bone health of young women treated. The Department of endocrinology, gynecology and pediatric diabetes of Necker-Enfants Malades hospital, follows many young girls taking a macro progestin treatment. This study is exclusively descriptive and will focus on the clinical and medical datas available on the bone health of these patients.
NCT05691270
The goal of this study is to pilot test the IN-Control Birth Control Navigator Program in Central Indiana for use by adolescents who would like to access birth control. The investigators hypothesize that facilitating access to contraception through our intervention will ultimately result in increased feelings of autonomy around these decisions and use of hormonal contraception.
NCT06345586
The purpose of this study is to study the effect of Drospirenone on cervical mucus change by modified Insler score, pre-bariatric surgery and post-bariatric surgery
NCT07115849
The aim of the project is to elucidate the impact of diverse sex hormone profiles on the adaptability of muscle mass to physical training. Additionally, the project aims to investigate secondary effects on adipose tissue, tendons, and other physiological parameters associated with physical function.
NCT07443865
Information, education and communication about contraception are essential to enable all people to make informed and responsible decisions about their lives. Despite the introduction of compulsory sex education in schools and the national sexual health strategy, the rate of voluntary termination of pregnancy among those under 20 years of age is still high. Moreover, the contraceptives used by those under 20 years of age are mainly pills and condoms, which have the least effectiveness in practice (92% for the pill and 85% for the condom).
NCT06299475
To increase sexual and reproductive health and rights through the improvement of contraceptive counseling and easy access to service and, thus, women's use of effective contraceptives after purchase of an emergency contraceptive pill (ECP).
NCT06672016
The Sponsor is developing a progestin-only contraceptive transdermal system (patch). The main purpose of this study is to look at how safe the study patch is and how well it works in preventing pregnancy. The study will also look at how well the study patch is tolerated. The study patch is a transdermal system that contains the active ingredient, progestin.
NCT04626596
The primary purpose of this study is to assess the efficacy and safety of the etonogestrel (ENG) contraceptive implant during participants' fourth and fifth years of use when used as the only method of contraception. The ENG implant is currently approved for a 3-year duration, and this study aims to confirm available evidence suggesting that the ENG implant remains highly effective when used up to 5 years.
NCT05022134
This is a prospective study involving two phases: 1) adaptation and 2) intervention, in adolescents aged 14-21 experiencing homelessness. The overarching goal is to develop and evaluate the effectiveness and feasibility of a counselling intervention to improve access to contraception among AYA experiencing homelessness. During the first phase, referred to as the adaption phase, we will rely on collective input from formative groups of AYA experiencing homelessness to adapt the CHOICE counselling intervention for this underserved and under-resourced population. In the second phase, referred to as the intervention phase, we will evaluate the effectiveness and feasibility of the adapted intervention (CHOICE-AYA).
NCT07393334
NLS-133-CLIN001 is a Phase 2a study designed to assess the safety, tolerability, and effects of NLS-133 (combination of two FDA-approved agents) compared to an active control (FDA-approved pharmacologic agent) or placebo on semen volume and sperm count in 10 in healthy men. Participants will be randomized in a crossover design to receive a single dose of NLS-133, an active control or placebo either 90 or 180 minutes prior to collection of semen. Sperm parameters measured will be count, motility and morphology. A brief questionnaire will be completed by each subject during each treatment cycle that addresses orgasm and ejaculation quality. Safety monitoring will include adverse event reporting, laboratory assessments, and vital signs.
NCT05285670
Use of a mobile health (mHealth) intervention to provide reproductive life counseling to women living with HIV may improve delivery of integrated reproductive health/HIV services and prevent adverse reproductive health outcomes. The proposed study will evaluate SMS platform and reproductive health counseling intervention in a cluster randomized controlled trial among women receiving routine HIV care, and plan for future implementation with qualitative and health economic analyses.
NCT06296797
The goal of this study is to understand whether providing information to women with a strong desire to avoid future pregnancy about how tubal sterilization compares to long-acting reversible contraceptives improves perceived access to available contraceptives. Participants will: * Complete a baseline survey * Receive access to web-based educational resources * Complete a brief follow up survey immediately after exploring these web-based resources * Complete a follow-up survey 3 months after enrolling The investigators will compare outcomes among participants provided with access to a new website (intervention) summarizing recent patient-centered outcomes research (PCOR) comparing interval laparoscopic tubal sterilization and long-acting reversible contraception (LARC) to control participants provided with access to the existing Planned Parenthood website on tubal sterilization.
NCT07365904
A single-centre, open-label, randomised, phase II study on the maintenance of ovulation inhibition after intentional application errors during 84 days of treatment with MR 130A 01 contraceptive transdermal patch