A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha...
Ovarian CancerOvarian Neoplasms23 moreThis study, ELU- FRα-1, is focused on adult subjects who have advanced, recurrent or refractory folate receptor alpha (FRα) overexpressing tumors considered to be topoisomerase 1 inhibitor-sensitive based on scientific literature, and, in the opinion of the Investigator, have no other meaningful life-prolonging therapy options available. ELU001 is a new chemical entity described as a C'Dot drug conjugate (CDC), consisting of payloads (exatecans) and targeting moieties (folic acid analogs) covalently bound by linkers to the C'Dot particle carrier. ELU001 will be the first drug-conjugate of its kind to be introduced into the clinic, a first in class, and a novel molecular entity.
Adebrelimab Combined With Fuzuloparib in the Treatment of Patients With Recurrent Platinum-resistant...
Ovarian NeoplasmsOvarian DiseasesThis is a single-arm, exploratory study. People with recurrent platinum-resistant ovarian cancer who have not received any previous systemic antitumor therapy for esophageal cancer were selected to evaluate the efficacy and safety of adebrelimab combined with fuzuloparib.
Pembrolizumab and Lenvatinib for Platinum- Sensitive Recurrent Ovarian Cancer
Ovarian NeoplasmsCarcinoma9 moreThis is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) for the treatment of platinum sensitive recurrent ovarian cancer. Participants will receive pembrolizumab and lenvatinib.
AB-1015, an Integrated Circuit T (ICT) Cell Therapy in Patients With Platinum Resistant Epithelial...
CarcinomaOvarian Epithelial10 moreThis is a multi-center, open-label phase 1 dose escalation trial that uses a modified 3+3 design to identify a recommended phase 2 dose (RP2D) of AB-1015 cell product. Backfill cohorts will enroll additional subjects at doses deemed to be safe for a total enrollment of up to 12 subjects per each backfill cohort on the protocol.
The Relationship With Mad Honey Containing Grayanotoxin and Ovary Tissue
Ovary DiseaseFor our working group, eighteen healthy Sprague-Dawley female rats were recruited and separated into three groups in an experimental animal laboratory. Group 1 was given mad honey (n:6) (80 mg/kg); Group 2 was given normal honey (n:6) (80 mg/kg), and Group 3 was the control group (n:6). The groups were given normal and mad honey by oral gavage for 30 days in this study. Rats were anesthetized intramuscularly with 50 mg/kg ketamine and 5 mg/kg xylazine on the 30th day of the study. At the conclusion of the study, female rats in the proestrus phase of the estrous cycle (as indicated by vaginal smear) were sacrificed and their ovarian tissues were placed in neutral formalin solution.
Anlotinib Combined With Carboplatin/Paclitaxel as First-line Treatment in Patients With Advanced...
Ovarian NeoplasmsFallopian Tube Neoplasms17 moreIt has been reported that antiangiogenic drugs combined with chemotherapy as first-line treatment, and subsequent antiangiogenic drugs as maintenance therapy for ovarian cancer can achieve better clinical benefits. Therefore, this study is expected to investigate the efficacy and safety of anlotinib combined with carboplatin/paclitaxel as first-line treatment in patients with advanced ovarian cancer.
Letrozole Versus Hormonal Preparation in Frozen Cycles of PCOS Patients.
Frozen Embryo TransferPolycystic Ovarian Disease4 moreOne of the indications of freezing is to reduce the risk of ovarian hyperstimulation syndrome particularly in polycystic ovarian disease (PCOS) women. Very few RCTs addressed the issue of optimizing the endometrium for a frozen cycle. Interestingly, Letrozole for ovarian stimulation showed significantly better reproductive outcome when compared with hormone replacement therapy (HRT) cycle. In addition, HRT cycle has been associated with higher miscarriage rate when compared with natural cycle frozen embryo transfer. Nevertheless, there is not yet a well-designed prospective randomized study comparing letrozole and HRT in PCOS women undergoing frozen embryo transfer.
Turner Syndrome Minipuberty Study
Turner SyndromeInfertility6 moreRationale: Due to accelerated germ cell loss, infertility is a major problem in girls with Turner syndrome (TS). Therefore, cryopreservation of ovarian tissue or oocytes before exhaustion of the ovarian reserve may preserve fertility in patients with TS. However, in the majority of females with TS , the ovarian reserve is exhausted before the age of menarche. Early markers indicating and predicting the ovarian reserve are necessary. During mid-childhood the hypothalamic-pituitary-gonadal (HPG) axis is quiescent and gonadotropins are usually unmeasurable. Nonetheless, this axis is active during infancy. Therefore, gonadotropins are measurable with peak values at 3 months of age and with lower (but still measurable) values at 9 months of age, in a period called the minipuberty. The aim of this study is to find markers of ovarian capacity, during the minipuberty, in order to predict ovarian reserve in the future. Objective: The hormonal range of LH, FSH, AMH, inhibin B, testosterone and estradiol in girls with TS during the minipuberty and the relation of the hormone serum levels with the karyotype. Study design: A prospective, cohort study with a duration of 3 years. Study population: Girls with a pre- or perinatal diagnosis TS who are born in a medical centre in the Netherlands during the duration of the study Main study parameters/endpoints: Serum levels of FSH, LH, AMH, inhibin B, testosterone and estradiol at the age of 3 and 9 months.
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction,...
Turner SyndromePost-menarcheal Adolescents4 moreBackground: Turner Syndrome, galactosemia, and premature ovarian insufficiency are all conditions that may make it very hard or impossible for a person to become pregnant and have their own child. Researchers want to learn more about why this happens and if freezing Gonadal tissue allows for fertility preservation. Objective: To find out why people with certain conditions have can have premature ovarian insufficiency (POI or early menopause) and individuals with variations in sex characteristics have trouble getting pregnant and if freezing the gonads tissue from them will help to have their own child in the future. Eligibility: Individuals aged 4-12 who have Turner Syndrome or galactosemia. Also, females aged 13-21 with premature ovarian insufficiency and Individuals with variations in sex characteristics Design: Participants will be screened with a medical history. Participants may have a physical exam and blood tests. Their body measurements may be taken. These include weight, height, arm span, skin fold, and sitting height. They may fill out surveys about their quality of life, body image, and health. Participants may have a transabdominal pelvic ultrasound. A probe will be placed on their belly and will take pictures of the organs in the pelvis. They may have a transvaginal pelvic ultrasound performed while asleep in the operating room if needed. Participants may have surgery to remove an gonads and skin biopsy. The removed tissue will be frozen and stored. The tissue will have to be stored for many years. NIH will pay to store the tissue for 1 year. After that, participants will have to pay for storage. A piece of the gonads (no more than 20%) will be used for research Travel, lodging and meals for participants traveling greater than 50 miles will be reimbursed based off the government rate. Local participants will not be reimbursed. Participants will have a checkup 6 weeks after surgery one or more follow-up visits 6-18 months after surgery. They may have phone follow-up every 12-24 months after surgery. Participation will last 30 years.
A Study of the Safety and Pharmacokinetics of AGS-8M4 Given in Combination With Chemotherapy in...
CarcinomaOvarian Cancer2 moreThis is a parallel arm study to evaluate AGS-8M4 administered in combination with chemotherapy in subjects with ovarian cancer. AGS-8M4 will be administered as an IV infusion until disease worsens.