IVMIVMNCT05793931
A Pilot Study to Determine the Feasibility, Acceptance, and Effectiveness of In-vitro Maturation in Patients Without IVF Coverage
An observational study of IVM and PCOS, run by Northwestern University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2021to 1 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: We seek to recruit 20 couples that fit the inclusion criteria as stated above.
Who may be able to join
- Patients without insurance coverage for IVF
- Female partner between age 18-3540
- Female partner with a diagnosis of polycystic ovarian syndrome (PCOS) or polycystic appearing ovaries (PCAO) as defined by an antral follicle count ≥ 15
- Presence of both ovaries
- Female partner with body mass index (BMI) of 19-4035 kg/m2
- Female partner with a normal uterine cavity as assessed by hysteroscopy, hysterosalpingography, or sonohysterography within the last 12 months
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- 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
- Male partner between age 18-45
- Male partner must be able to produce fresh semen sample
- Male partner with sperm concentration ≥ 5 million sperm/mL and sperm motility ≥ 25%
- English speaking
Who cannot join
- Frozen sperm source
- Presence of ovarian pathology (i.e., endometrioma, fibroma)
- History of HIV or acute hepatitis infection
- History of chemotherapy or pelvic radiation therapy
- Any active, uncontrolled, clinically significant medical condition as determined by the investigator
- Contradiction to pregnancy
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- Adults unable to consent
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Breaking Down Financial Barriers: A Pilot Study to Determine the Feasibility, Acceptance, and Effectiveness of In-vitro Maturation in Patients Without IVF Coverage
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.
- Keywords
- IVM, PCOS, PCAO
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From treatment start to live birth (~10 months)
Secondary outcomes (4)
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.
Measured: From treatment start to day 3 or day 5 of blastocyst development (~3 weeks)
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.
Measured: From fertilization to day 3 or day 5 of blastocyst development (up to 1 week)
Efficacy of IVM on pregnancy
The rate at which IVM results in not pregnant, biochemical, clinical pregnancy, miscarriage, ectopic, or pregnancy of unknown location.
Measured: From treatment start to birth or loss (up to 10 months)
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.
Measured: From treatment start to hCG trigger (~2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start16 Nov 2021
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Why it stopped: Funding expired 03/01/2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVMStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793931
- Sponsor's protocol ID
- STU00213583
- Acronym
- IVM
- Status last verified
- Mar 2024
- First submitted
- 21 Feb 2023
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breaking Down Financial Barriers: A Pilot Study to Determine the Feasibility, Acceptance, and Effectiveness of In-vitro Maturation in Patients Without IVF Coverage
- ClinicalTrials.gov ID
- NCT05793931
- Acronym / sponsor ID
- IVM / STU00213583
- Keywords
- IVM, PCOS, PCAO
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding expired 03/01/2023
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- We seek to recruit 20 couples that fit the inclusion criteria as stated above.
Key inclusion criteria (11 listed)
- Patients without insurance coverage for IVF
- Female partner between age 18-3540
- Female partner with a diagnosis of polycystic ovarian syndrome (PCOS) or polycystic appearing ovaries (PCAO) as defined by an antral follicle count ≥ 15
- Presence of both ovaries
- Female partner with body mass index (BMI) of 19-4035 kg/m2
Key exclusion criteria (9 listed)
- Frozen sperm source
- Presence of ovarian pathology (i.e., endometrioma, fibroma)
- History of HIV or acute hepatitis infection
- History of chemotherapy or pelvic radiation therapy
- Any active, uncontrolled, clinically significant medical condition as determined by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Statistical analysis of live birth rates from IVM
Time frame: From treatment start to live birth (~10 months)
Measurements for analysis include: gestational age at delivery, mode of delivery, birth weight, gender, neonatal and obstetric complications
4 secondary outcomes
Statistical analysis of IVM on oocyte retrieval and maturation
Time frame: From treatment start to day 3 or day 5 of blastocyst development (~3 weeks)
Statistical analysis of IVM on embryo parameters
Time frame: From fertilization to day 3 or day 5 of blastocyst development (up to 1 week)
Efficacy of IVM on pregnancy
Time frame: From treatment start to birth or loss (up to 10 months)
Statistical analysis of IVM on endometrial response to hormones
Time frame: From treatment start to hCG trigger (~2 weeks)
Results and safety
The study was stopped early (reason given: Funding expired 03/01/2023). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IVM and PCOS, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding expired 03/01/2023). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Statistical analysis of live birth rates from IVM (time frame: From treatment start to live birth (~10 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.