InfertilityIVMNCT01550861
In Vitro Maturation (IVM) of Human Oocytes
A study testing in vitro maturation and Polar Body Biopsy with preimplantation genetic screening in people with Infertility, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The objectives of this study are to evaluate the clinical efficacy of Natural in vitro Fertilization and in vitro maturation. Read more about this study
- Who is it for?
- Ages 25 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- in vitro maturation and Polar Body Biopsy with preimplantation genetic screening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2012to 18 Sep 2023
- 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 25 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Each subject must be female.
- Each subject must have an indication for COH and IVF with or without ICSI.
- Each subject must be willing and able to provide written informed consent for the trial
- Each subject must be 25 to ≤42 years of age at the time of signing informed consent.
- Each subject must have a normal cervical smear result (no atypical or abnormal cells, or in case of atypical squamous or glandular cells, no signs of malignancy; corresponding to Papanicolaou [PAP] I or II) obtained within 12 months prior to signing informed consent must be available
Who cannot join
- Subject with premature ovarian failure
- Subject with endocrine abnormalities such as hyperprolactinaemia or thyroid dysfunction
- Subject with malformation or absence of uterus
- Subject has tested positive for Human Immunodeficiency Virus (HIV) or Hepatitis B (by local laboratory; results obtained within 1 year prior to signing ICF are considered valid).
- Subject with contraindication or allergy/hypersensitivity to hCG, estrogen and progesterone
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Reproductive Medicine- Weill Cornell Medical College
New York, New York, 10021
About this study
The objectives of this study are to evaluate the clinical efficacy of Natural in vitro Fertilization and in vitro maturation.
Read the detailed description
Collection of one mature egg from a follicle in the ovary without gonadotropin medications (natural cycle IVF) results in low pregnancy rates. One way to improve natural cycle IVF is to combine this procedure with the removal of immature eggs from the ovary and mature these eggs in the laboratory ( in vitro maturation-IVM). The in vitro mature eggs are fertilized and the resultant embryos are cultured using conventional IVF techniques.
- Conditions
- Infertility
- Being tested
- in vitro maturation, Polar Body Biopsy with preimplantation genetic screening
- Keywords
- infertility, in vitro maturation (IVM), in vitro fertilization (IVF), natural cycle
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in vitro maturationProcedure or surgery
Maturation of immature oocytes in the laboratory following oocyte retrieval
Polar Body Biopsy with preimplantation genetic screeningProcedure or surgery
Polar body biopsy is performed on the day that the oocyte is retrieved. Microarray analysis will will be performed and compared with FISH and microarray analysis of day 3 or day 5 biopsy.
| Study group | Role | What they receive |
|---|---|---|
| In vitro Maturation | Experimental | in vitro maturation of immature oocytes Receives: Procedure: in vitro maturation; Procedure: Polar Body Biopsy with preimplantation genetic screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of oocytes retrieved and embryos generated
Measured: 1 year
Secondary outcomes (1)
live birth rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study start15 Feb 2012
- Primary completion15 Oct 2022
- Study completion18 Sep 2023
Why it stopped: Low accrual
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.
- More trials run by Weill Medical College of Cornell 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zev Rosenwaks, MD, Principal investigator, Weill Cornell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550861
- Sponsor's protocol ID
- 1201012117
- Acronym
- IVM
- Status last verified
- Nov 2023
- First submitted
- 16 Feb 2012
- Last updated
- 18 Nov 2023
- 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Maturation (IVM) of Human Oocytes
- ClinicalTrials.gov ID
- NCT01550861
- Acronym / sponsor ID
- IVM / 1201012117
- Conditions
- Infertility
- Keywords
- infertility, in vitro maturation (IVM), in vitro fertilization (IVF), natural cycle
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 15 Feb 2012 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 18 Sep 2023 (actual)
- First posted
- 12 Mar 2012 (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.
The objectives of this study are to evaluate the clinical efficacy of Natural in vitro Fertilization and in vitro maturation.
Detailed description
Collection of one mature egg from a follicle in the ovary without gonadotropin medications (natural cycle IVF) results in low pregnancy rates. One way to improve natural cycle IVF is to combine this procedure with the removal of immature eggs from the ovary and mature these eggs in the laboratory ( in vitro maturation-IVM). The in vitro mature eggs are fertilized and the resultant embryos are cultured using conventional IVF techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In vitro Maturation | Experimental | Procedure: in vitro maturation, Procedure: Polar Body Biopsy with preimplantation genetic screeningin vitro maturation of immature oocytes |
Who may qualify
- Ages
- 25 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Each subject must be female.
- Each subject must have an indication for COH and IVF with or without ICSI.
- Each subject must be willing and able to provide written informed consent for the trial
- Each subject must be 25 to ≤42 years of age at the time of signing informed consent.
- Each subject must have a normal cervical smear result (no atypical or abnormal cells, or in case of atypical squamous or glandular cells, no signs of malignancy; corresponding to Papanicolaou [PAP] I or II) obtained within 12 months prior to signing informed consent must be available
Key exclusion criteria (5 listed)
- Subject with premature ovarian failure
- Subject with endocrine abnormalities such as hyperprolactinaemia or thyroid dysfunction
- Subject with malformation or absence of uterus
- Subject has tested positive for Human Immunodeficiency Virus (HIV) or Hepatitis B (by local laboratory; results obtained within 1 year prior to signing ICF are considered valid).
- Subject with contraindication or allergy/hypersensitivity to hCG, estrogen and progesterone
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 |
|---|---|---|
| in vitro maturationMaturation of immature oocytes in the laboratory following oocyte retrieval | Procedure or surgery | In vitro Maturation |
| Polar Body Biopsy with preimplantation genetic screeningPolar body biopsy is performed on the day that the oocyte is retrieved. Microarray analysis will will be performed and compared with FISH and microarray analysis of day 3 or day 5 biopsy. | Procedure or surgery | In vitro Maturation |
Primary outcome
number of oocytes retrieved and embryos generated
Time frame: 1 year
1 secondary outcome
live birth rate
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Center for Reproductive Medicine- Weill Cornell Medical CollegeLink provided by the sponsor.
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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.
Zev Rosenwaks, MD principal investigator
Weill Cornell
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing in vitro maturation and Polar Body Biopsy with preimplantation genetic screening in people with Infertility, run by Weill Medical College of Cornell 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 5 inclusion and 5 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 18 Nov 2023. 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: Low accrual). 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?
number of oocytes retrieved and embryos generated (time frame: 1 year). 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 18 Nov 2023.