Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT05793931 |
| Other study ID # |
STU00213583 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 16, 2021 |
| Est. completion date |
March 1, 2023 |
Study information
| Verified date |
March 2024 |
| Source |
Northwestern University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
