HealthyNCT06633120
In Vitro Maturation of Human Eggs
A study testing IVM in people with Healthy and PCOS, run by Colorado Center for Reproductive Medicine at 1 site in United States.
Trial summary
CCRM Fertility, a global pioneer in fertility treatment, research and science, is seeking participants for a new study on in vitro maturation (IVM). IVM requires less hormones to stimulate the ovaries than IVF, making it more affordable than IVF with fewer side effects. Read more about this study
- Who is it for?
- Ages Up to 38 years, women only
- Conditions the study is for
- Healthy, PCOS, PCOS (Polycystic Ovary Syndrome)
- What is being tested?
- IVM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2023to 30 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 38 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Infertile women diagnosed with PCOS or polycystic ovaries, or infertile women with good ovarian reserve
- Antral follicle count (AFC) greater than 24
- AMH greater than 3.5 ng/ml
- Body Mass Index less than 35
- Accept to have embryos biopsied for PGT
- Intend to perform embryo transfer within 4 months after completing the IVM cycle
- Paternal (or donor) age \<45, ejaculated sperm collection only (partner frozen and donor sperm acceptable), sperm morphology (strict criteria) \>1%, motility \> 20% and sperm count \> 10 million per ml (so samples can be prepared through standard procedure)
Who cannot join
- More than 2 failed IVF cycles
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Colorado Center for Reproductive Medicine
Lone Tree, Colorado, 80124
Rachel Study Coordinator, 303-788-8300 ext. 1769, RachelM@colocrm.com
Ye Yuan, PhD
About this study
CCRM Fertility, a global pioneer in fertility treatment, research and science, is seeking participants for a new study on in vitro maturation (IVM). IVM requires less hormones to stimulate the ovaries than IVF, making it more affordable than IVF with fewer side effects. Participants that qualify for the study will receive a free cycle of IVM treatment at CCRM Fertility and including a new patient consultation, fertility testing, preimplantation genetic testing for aneuploidies (PGT-A), anesthesia and some medication
Read the detailed description
Patients will undergo a complete IVF workup to qualify for study. Once passing their baseline appointment patients will undergo a three day low dose stimulation followed by egg retrieval 18-22 hours post last medication dosage. Immature oocytes will be retrieved from the ovaries via ultrasound guided TV aspiration and matured overnight in the laboratory. Mature oocytes will be fertilized via ICSI the following day and cultured to the blastocyst stage. Biopsy of the first 14 blastocysts are included with this package, patients have the option biopsy additional embryos if available. Biopsies will be sent for PGTA testing. This study also includes preparation for and the first frozen embryo transfer. Some FET medication is included as well as testing through the first pregnancy test.
- Conditions
- Healthy, PCOS, PCOS (Polycystic Ovary Syndrome), Ovarian Reserve, Infertility, Infertility Female
- Being tested
- IVM
- Keywords
- IVM, Infertility, PCOS, IVF
- Medical subject headings
- Polycystic Ovary Syndrome, Infertility, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVMOther
Immature oocytes will be retrieved from small ovarian follicles and matured overnight in the laboratory prior to undergoing fertilization and embryo culture.
| Study group | Role | What they receive |
|---|---|---|
| Biphasic IVM Treatment | Experimental | Biphasic IVM of oocytes Receives: Other: IVM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oocyte maturation
Maturation rate of retrieved oocytes
Measured: 27 hours
Embryo fertilization and development
Number of embryos that fertilize and develop after ICSI. Blastocysts will be biopsied and frozen on days 5, 6, and 7 of development
Measured: 7 days
Pregnancy
Pregnancy following embryo transfer. HCG levels and ultrasound confirming IUP and heartrate.
Measured: 6 months
Secondary outcomes (1)
Live Birth
Birth information (sex of infant, status, weight, and any complications) will be collected via patient contact when possible.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start3 Feb 2023
- Primary completion31 Jul 2029 (estimated)
- Study completion30 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colorado Center for Reproductive Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633120
- Sponsor's protocol ID
- 20141020
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared through publication in scientific journals.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Maturation of Human Eggs
- ClinicalTrials.gov ID
- NCT06633120
- Acronym / sponsor ID
- 20141020
- Conditions
- Healthy, PCOS, PCOS (Polycystic Ovary Syndrome), Ovarian Reserve, Infertility, Infertility Female
- Keywords
- IVM, Infertility, PCOS, IVF
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Colorado Center for Reproductive MedicineUniversity, hospital or other
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 30 Aug 2030 (estimated)
- First posted
- 9 Oct 2024 (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.
CCRM Fertility, a global pioneer in fertility treatment, research and science, is seeking participants for a new study on in vitro maturation (IVM). IVM requires less hormones to stimulate the ovaries than IVF, making it more affordable than IVF with fewer side effects. Participants that qualify for the study will receive a free cycle of IVM treatment at CCRM Fertility and including a new patient consultation, fertility testing, preimplantation genetic testing for aneuploidies (PGT-A), anesthesia and some medication
Detailed description
Patients will undergo a complete IVF workup to qualify for study. Once passing their baseline appointment patients will undergo a three day low dose stimulation followed by egg retrieval 18-22 hours post last medication dosage. Immature oocytes will be retrieved from the ovaries via ultrasound guided TV aspiration and matured overnight in the laboratory. Mature oocytes will be fertilized via ICSI the following day and cultured to the blastocyst stage. Biopsy of the first 14 blastocysts are included with this package, patients have the option biopsy additional embryos if available. Biopsies will be sent for PGTA testing. This study also includes preparation for and the first frozen embryo transfer. Some FET medication is included as well as testing through the first pregnancy test.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biphasic IVM Treatment | Experimental | Other: IVMBiphasic IVM of oocytes |
Who may qualify
- Ages
- Up to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Infertile women diagnosed with PCOS or polycystic ovaries, or infertile women with good ovarian reserve
- Antral follicle count (AFC) greater than 24
- AMH greater than 3.5 ng/ml
- Body Mass Index less than 35
- Accept to have embryos biopsied for PGT
Key exclusion criteria (1 listed)
- More than 2 failed IVF cycles
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 |
|---|---|---|
| IVMImmature oocytes will be retrieved from small ovarian follicles and matured overnight in the laboratory prior to undergoing fertilization and embryo culture. | Other | Biphasic IVM Treatment |
Primary outcome
Oocyte maturation
Time frame: 27 hours
Maturation rate of retrieved oocytes
Embryo fertilization and development
Time frame: 7 days
Number of embryos that fertilize and develop after ICSI. Blastocysts will be biopsied and frozen on days 5, 6, and 7 of development
Pregnancy
Time frame: 6 months
Pregnancy following embryo transfer. HCG levels and ultrasound confirming IUP and heartrate.
1 secondary outcome
Live Birth
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: Yes. IPD will be shared through publication in scientific journals.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVM in people with Healthy and PCOS, run by Colorado Center for Reproductive Medicine 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 7 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 9 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth A Jannaman, BS (303-788-8300 ext. 1123, EJannaman@CCRMIVF.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oocyte maturation (time frame: 27 hours). The study lists 3 primary outcomes in all. 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 9 Oct 2024.