InfertilityIVMNCT02516462
In Vitro Maturation of Human Eggs
A study testing IVM media and Follicle Stimulating Hormone (FSH) in people with Infertility and Reproductive Techniques, Assisted, run by National Foundation for Fertility Research at 2 sites in United States.
Trial summary
Because a large proportion of the embryo's quality is dependent upon the egg, this investigation focuses on treatment of the oocyte during in vitro maturation (IVM). In typical IVF cycles, the egg is recovered when it is mature and ready to be fertilized. Read more about this study
- Who is it for?
- Ages 21 to 35 years, women only
- Conditions the study is for
- Infertility, Reproductive Techniques, Assisted
- What is being tested?
- IVM media and Follicle Stimulating Hormone (FSH)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2015to Dec 2022
- Phase
- Interventional
- 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 21 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertile women who desire to conceive and come to CCRM for infertility treatment using IVF will be candidates for this study.
- Women with PCOS
- Patients can be of any race, culture, sexual orientation or ethnicity.
Who cannot join
- Minors are excluded from participation in this study.
- Women with a BMI greater than 40
- Women whose health is such that becoming pregnant carries risk significantly greater than healthy women are excluded from this study, unless they use a gestational carrier under the direction of their physician.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Fertility Laboratories of Colorado
Lone Tree, Colorado, 80124
Lindsey Munkwitz, RN, 303-788-8300, IVMstudy@colocrm.com
Rebecca L Krisher, PhD, 303-788-8300, IVMstudy@colocrm.com
- Recruiting
National Foundation for Fertility Research
Lone Tree, Colorado, 80124
Rebecca L Krisher, PhD, 303-788-8300, IVMstudy@colocrm.com
About this study
Because a large proportion of the embryo's quality is dependent upon the egg, this investigation focuses on treatment of the oocyte during in vitro maturation (IVM). In typical IVF cycles, the egg is recovered when it is mature and ready to be fertilized. However, at this point the oocyte's quality has been set, and cannot be altered. Therefore, to have an impact on oocyte quality the use of in IVM is critical. Development of a successful IVM protocol for clinical use would not only provide an option for women of advanced maternal age, it would also reduce the cost of IVF due to fewer exogenous gonadotropins used for stimulation, and significantly lessen the risk of ovarian hyper-stimulation.
The objective of this research study is to evaluate a newly developed oocyte maturation media system for human clinical use in assisted reproductive technology (ART).
Read the detailed description
The novel device (IVM media system), is designed to support nuclear maturation of immature oocytes recovered after minimal ovarian stimulation with no LH/hCG administration, and improve oocyte competence. This may result in development of a greater number of embryos to the blastocyst stage.
FSH is administered starting on cycle day 3 to stimulate follicle growth. When the leading follicle reaches 12-14 mm, egg retrieval will be scheduled. No hCG/LH trigger will be administered. Specially designed maturation media is used to collect and culture the immature eggs once recovered from the follicle. Once the eggs have matured in vitro, fertilization and embryo culture, vitrification and comprehensive chromosomal screening will be completed as per standard operating procedures.
- Conditions
- Infertility, Reproductive Techniques, Assisted
- Being tested
- IVM media, Follicle Stimulating Hormone (FSH)
- Medical subject headings
- Infertility, Helping Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVM mediaDevice
Media to support the nuclear maturation and cytoplasmic competence of human oocytes in culture.
Follicle Stimulating Hormone (FSH)Drug
Low dose FSH is administered to stimulate follicle growth.
| Study group | Role | What they receive |
|---|---|---|
| IVM | Experimental | Immature oocytes recovered from each subject will be placed into IVM media for maturation. Receives: Device: IVM media; Drug: Follicle Stimulating Hormone (FSH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy
The incidence of pregnancy following embryo transfer of IVM produced embryos.
Measured: 6 months after egg retrieval
Secondary outcomes (5)
Development of good quality blastocysts using the Gardner morphological blastocyst grading system
The proportion of good quality blastocyst stage embryos developed from IVM eggs during in vitro fertilization (IVF), of the total number of oocytes recovered
Measured: 7 days after egg retrieval
Offspring Weight
The birth weight of children born following IVM
Measured: 1 year after egg retrieval
Offspring Gender
The gender of children born after IVM
Measured: 1 year after egg retrieval
Fertilization of eggs
The percentage of mature eggs that are successfully fertilized following IVM and IVF
Measured: 2 days after egg retrieval
Euploid Embryos
The percentage of euploid embryos produced as analyzed by comprehensive chromosome screening, of total embryos tested
Measured: 1 month after egg retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Foundation for Fertility Research
- Sponsor type
- University, hospital or other
- Collaborators
- Fertility Laboratories Of Colorado
- Responsible party
- Sponsor
- Investigators
- Rebecca L Krisher, PhD, Study director, CCRM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516462
- Sponsor's protocol ID
- NFFR-IVM-2015
- Acronym
- IVM
- Status last verified
- May 2020
- First submitted
- 30 Jul 2015
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Maturation of Human Eggs
- ClinicalTrials.gov ID
- NCT02516462
- Acronym / sponsor ID
- IVM / NFFR-IVM-2015
- Conditions
- Infertility, Reproductive Techniques, Assisted
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Foundation for Fertility ResearchUniversity, hospital or other
- Collaborators
- Fertility Laboratories Of Colorado
- Study start
- Jul 2015
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 6 Aug 2015 (estimated)
- 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.
Because a large proportion of the embryo's quality is dependent upon the egg, this investigation focuses on treatment of the oocyte during in vitro maturation (IVM). In typical IVF cycles, the egg is recovered when it is mature and ready to be fertilized. However, at this point the oocyte's quality has been set, and cannot be altered. Therefore, to have an impact on oocyte quality the use of in IVM is critical. Development of a successful IVM protocol for clinical use would not only provide an option for women of advanced maternal age, it would also reduce the cost of IVF due to fewer exogenous gonadotropins used for stimulation, and significantly lessen the risk of ovarian hyper-stimulation.
The objective of this research study is to evaluate a newly developed oocyte maturation media system for human clinical use in assisted reproductive technology (ART).
Detailed description
The novel device (IVM media system), is designed to support nuclear maturation of immature oocytes recovered after minimal ovarian stimulation with no LH/hCG administration, and improve oocyte competence. This may result in development of a greater number of embryos to the blastocyst stage.
FSH is administered starting on cycle day 3 to stimulate follicle growth. When the leading follicle reaches 12-14 mm, egg retrieval will be scheduled. No hCG/LH trigger will be administered. Specially designed maturation media is used to collect and culture the immature eggs once recovered from the follicle. Once the eggs have matured in vitro, fertilization and embryo culture, vitrification and comprehensive chromosomal screening will be completed as per standard operating procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IVM | Experimental | Device: IVM media, Drug: Follicle Stimulating Hormone (FSH)Immature oocytes recovered from each subject will be placed into IVM media for maturation. |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Infertile women who desire to conceive and come to CCRM for infertility treatment using IVF will be candidates for this study.
- Women with PCOS
- Patients can be of any race, culture, sexual orientation or ethnicity.
Key exclusion criteria (3 listed)
- Minors are excluded from participation in this study.
- Women with a BMI greater than 40
- Women whose health is such that becoming pregnant carries risk significantly greater than healthy women are excluded from this study, unless they use a gestational carrier under the direction of their physician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVM mediaMedia to support the nuclear maturation and cytoplasmic competence of human oocytes in culture. | Device | IVM |
| Follicle Stimulating Hormone (FSH)Low dose FSH is administered to stimulate follicle growth. | Drug | IVM |
Primary outcome
Pregnancy
Time frame: 6 months after egg retrieval
The incidence of pregnancy following embryo transfer of IVM produced embryos.
5 secondary outcomes
Development of good quality blastocysts using the Gardner morphological blastocyst grading system
Time frame: 7 days after egg retrieval
Offspring Weight
Time frame: 1 year after egg retrieval
Offspring Gender
Time frame: 1 year after egg retrieval
Fertilization of eggs
Time frame: 2 days after egg retrieval
Euploid Embryos
Time frame: 1 month after egg retrieval
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
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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.
Rebecca L Krisher, PhD study director
CCRM
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVM media and Follicle Stimulating Hormone (FSH) in people with Infertility and Reproductive Techniques, Assisted, run by National Foundation for Fertility Research at 2 sites 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel Makloski, RN (303-788-8300, IVMstudy@colocrm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy (time frame: 6 months after egg retrieval). 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 15 May 2020.