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Actively Recruiting

Researchers are studying women undergoing IVF, ICSI, or frozen embryo transfer (FET) cycles to understand how adding a single dose of a GnRH agonist around the time of embryo transfer might improve pregnancy outcomes. The study focuses on enhancing implantation and live birth rates by supplementing the usual progesterone support given after IVF, as this hormonal interaction is crucial for the embryo to implant and develop properly in the uterus. Participants will receive either a single injection of a GnRH agonist or a placebo around the time of embryo transfer. This trial compares these two treatments to assess their effects on pregnancy success. The study is conducted in a Phase 4 trial setting, meaning it evaluates the treatment's effects after it has been approved for use. During the study, women will be monitored to determine the occurrence of live births within nine months after embryo transfer. Researchers will collect information related to pregnancy outcomes and track how the treatments affect live birth rates. The study involves women aged 18 to under 40 years old who are undergoing IVF/ICSI or FET cycles without day 3 embryo transfers.

Age: 18Years - 40YearsFEMALEPhase 4
1 location
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Actively Recruiting

Researchers are evaluating the May Health System, a device designed to restore ovulation in women with infertility caused by polycystic ovary syndrome (PCOS) who have not responded to or cannot undergo first-line ovulation induction treatments. This prospective, multicenter, randomized pivotal study focuses on assessing the safety and effectiveness of this transvaginal ultrasound-guided ovarian tissue ablation method in women aged 18 to 40 years. The study aims to provide evidence supporting this novel treatment approach. The intervention uses the May Health System, which consists of a needle-catheter ablation device attached to a vaginal ultrasound probe, an adapter, and a generator that delivers bipolar radiofrequency energy. Under conscious sedation, physicians guide the device transvaginally to the ovary and apply radiofrequency energy to ablate ovarian tissue. This procedure is intended to help restore ovulation in eligible women with PCOS-related infertility. The study includes follow-up periods lasting up to 36 months to monitor outcomes. Participants will undergo evaluations including ovulation tracking over three months and adverse event monitoring throughout the 36-month study duration. Assessments include transvaginal ultrasounds to confirm ovarian accessibility and size, fertility evaluations, and safety monitoring. Participants will provide informed consent and comply with scheduled follow-ups to measure ovulation occurrence and collect data on any adverse effects associated with the treatment.

Age: 18Years - 40YearsFEMALEPhase Not Applicable
24 locations
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