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TerminatedNCT05793931IVMUpdated Mar 26, 2024

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

An observational study in IVM and PCOS, sponsored by Northwestern University. Terminated at 1 site in United States. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-03-26.

Sponsored by Northwestern University · Observational

Why this study was terminated
Funding expired 03/01/2023
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • IVM
  • PCOS

Keywords

  • IVM
  • PCOS
  • PCAO
03

In context

Lead sponsor

Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

We seek to recruit 20 couples that fit the inclusion criteria as stated above.

Inclusion criteria

  1. Patients without insurance coverage for IVF
  2. Female partner between age 18-3540
  3. Female partner with a diagnosis of polycystic ovarian syndrome (PCOS) or polycystic appearing ovaries (PCAO) as defined by an antral follicle count ≥ 15
  4. Presence of both ovaries
  5. Female partner with body mass index (BMI) of 19-4035 kg/m2
  6. Female partner with a normal uterine cavity as assessed by hysteroscopy, hysterosalpingography, or sonohysterography within the last 12 months
  7. Female partner with a history of tubal sterilization OR Blocked fallopian tubes without evidence of a hydrosalpinx OR History of 3 or more previously failed cycles of ovulation induction with oral medications OR where IVF is recommended for the treatment of mild or moderate male factor infertility OR evidence of a polyp and infertility
  8. Male partner between age 18-45
  9. Male partner must be able to produce fresh semen sample
  10. Male partner with sperm concentration ≥ 5 million sperm/mL and sperm motility ≥ 25%
  11. English speaking

Exclusion criteria

Exclusion Criteria:

  1. Frozen sperm source
  2. Presence of ovarian pathology (i.e., endometrioma, fibroma)
  3. History of HIV or acute hepatitis infection
  4. History of chemotherapy or pelvic radiation therapy
  5. Any active, uncontrolled, clinically significant medical condition as determined by the investigator
  6. Contradiction to pregnancy
  7. Adults unable to consent
  8. Pregnant women
  9. Prisoners
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Statistical analysis of live birth rates from IVM

    Measurements for analysis include: gestational age at delivery, mode of delivery, birth weight, gender, neonatal and obstetric complications

    Time frame: From treatment start to live birth (~10 months)

Secondary outcomes

  1. Statistical analysis of IVM on oocyte retrieval and maturation

    The antral follicle count (AFC), number of eggs retrieved, number of eggs mature, number of eggs fertilized, number of eggs discarded, number of embryos transferred, number of embryos frozen will be assessed together to determine efficacy of IVM on oocyte maturation to embryo stage.

    Time frame: From treatment start to day 3 or day 5 of blastocyst development (~3 weeks)

  2. Statistical analysis of IVM on embryo parameters

    The number of gestational sacs present, morphology and morphokinetic embryo parameters will be combined to report statistical analysis of embryo development from IVM.

    Time frame: From fertilization to day 3 or day 5 of blastocyst development (up to 1 week)

  3. Efficacy of IVM on pregnancy

    The rate at which IVM results in not pregnant, biochemical, clinical pregnancy, miscarriage, ectopic, or pregnancy of unknown location.

    Time frame: From treatment start to birth or loss (up to 10 months)

  4. Statistical analysis of IVM on endometrial response to hormones

    The endometrial thickness on day of hCG trigger and number of total days of estrogen prior to hCG will be combined to assess the endometrial response to estrogen.

    Time frame: From treatment start to hCG trigger (~2 weeks)

07

Study locations

1 site
  • Northwestern Medicine
    Chicago, Illinois 60611, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05793931
Lead sponsor
Northwestern University
Responsible party
Sponsor
First posted
Mar 31, 2023
Start date
Nov 16, 2021
Primary completion
Mar 1, 2023
Completion
Mar 1, 2023
Last update
Mar 26, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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