NCT05793931

A Pilot Study to Determine the Feasibility, Acceptance, and Effectiveness of In-vitro Maturation in Patients Without IVF Coverage

Breaking Down Financial Barriers: A Pilot Study to Determine the Feasibility, Acceptance, and Effectiveness of In-vitro Maturation in Patients Without IVF Coverage

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The specific aim of this pilot study is to test the hypothesis that estrogen stimulated IVM will be non-inferior to traditional IVF, to determine the feasibility and acceptance of estrogen-stimulated in vitro maturation (IVM) among couples and if couples find value and satisfaction with IVM. This project will determine the feasibility, acceptance, and cost-benefit of in vitro maturation (IVM) among 20 couples who have had unsuccessful attempts at pregnancy using oral medications or whose only option to achieve pregnancy is through in vitro fertilization (IVF) due to blocked fallopian tubes or low sperm counts.

Detailed description

Initial treatment for infertility often involves the use of ovulation induction with or without intrauterine insemination. This is particularly useful in the large number of PCOS patients seeking care. However, 30-50% of couples fail such treatments and are recommended to pursue in vitro fertilization (IVF). While IVF remains the most effective of all infertility treatments, it is also the most expensive. The CDC's 2014 report on the utilization of infertility services in the U.S. estimated that between 2006-2010 approximately 67% of reproductive-aged women sought infertility services (advice, evaluation, and/or treatment). Of these women, only 6.9% used artificial insemination and 2.6% used IVF. In addition to improving access to IVF treatment by lowering costs, IVM has the potential to make IVF treatment safer for women. The injectable medications used in IVF often overstimulate the ovaries and can lead to developing a dangerous syndrome called ovarian hyperstimulation syndrome (OHSS). OHSS is a condition in which significant fluid shifts occur within a woman's blood vessels which can lead to ascites, pulmonary edema, difficulty breathing, and in rare cases, death. OHSS also poses the risk of severe blood clotting which can lead to heart attack, stroke, and pulmonary embolism - all potential lethal complications. In vitro maturation (IVM) is a technique where immature eggs are aspirated from the ovary without the use of injectable medications. The eggs are cultured to maturity in the laboratory which enables them to be fertilized. They are then fertilized in the laboratory and transferred back to the mother's uterus similar to traditional IVF. With improvements in IVM technique, recent data have shown that IVM can produce near comparable pregnancy rates to IVF and eliminate OHSS. Our goal is to determine the feasibility, acceptance, and effectiveness of IVM in couples who have a female partner with PCOS or polycystic appearing ovaries (PCAO). With the cost of traditional IVF ranging anywhere from $12,000 - $15,000 per cycle, the estimated $2,500- $4,000 cost of IVM may be a more cost-effective and safer strategy among couples. The results of this study not only have the potential to improve equity among those seeking infertility treatment, but also present an opportunity to serve as a springboard for future research aimed at advancing the care of all patients who seek fertility treatment.

Conditions

• IVM
• PCOS

Timeline

• Start date: 2021-11-16
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2023-03-31
• Last updated: 2024-03-26

Locations

1 site across 1 country: United States