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TerminatedNCT01550861IVMUpdated Nov 18, 2023

In Vitro Maturation (IVM) of Human Oocytes

An interventional study of in vitro maturation and Polar Body Biopsy with preimplantation genetic screening in Infertility, sponsored by Weill Medical College of Cornell University. Terminated at 1 site in United States. Open to female participants aged 25 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-18.

Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Treatment

Why this study was terminated
Low accrual
Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
25 Years to 42 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Infertility

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Keywords

  • infertility
  • in vitro maturation (IVM)
  • in vitro fertilization (IVF)
  • natural cycle
03

In context

Infertility

2,541 studies on the registry are indexed under Infertility; 405 are open to participants now.

This study's enrollment of 2 is below the median of 120 across 1,722 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 890 studies on the registry; 163 are open to participants now.

Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.

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

04

Who can participate

Ages eligible
25 Years to 42 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Each subject must be female.
  2. Each subject must have an indication for COH and IVF with or without ICSI.
  3. Each subject must be willing and able to provide written informed consent for the trial
  4. Each subject must be 25 to ≤42 years of age at the time of signing informed consent.
  5. 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

Exclusion criteria

Exclusion Criteria:

  1. Subject with premature ovarian failure
  2. Subject with endocrine abnormalities such as hyperprolactinaemia or thyroid dysfunction
  3. Subject with malformation or absence of uterus
  4. 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).
  5. Subject with contraindication or allergy/hypersensitivity to hCG, estrogen and progesterone
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    In vitro Maturation

    in vitro maturation of immature oocytes

    Procedure: in vitro maturation · Procedure: Polar Body Biopsy with preimplantation genetic screening

Interventions

  • Procedurein vitro maturation

    Maturation of immature oocytes in the laboratory following oocyte retrieval

  • ProcedurePolar Body Biopsy with preimplantation genetic screening

    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.

06

What researchers measure

Primary outcomes

  1. number of oocytes retrieved and embryos generated

    Time frame: 1 year

Secondary outcomes

  1. live birth rate

    Time frame: 1 year

07

Study locations

1 site
  • Center for Reproductive Medicine- Weill Cornell Medical College
    New York, New York 10021, United States
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2012 to primary completion in Oct 2022, 128 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 16, 2012
First posted
Mar 12, 2012
StartActual
Feb 15, 2012
Primary completionActual
Oct 15, 2022
CompletionActual
Sep 18, 2023
Last update
Nov 18, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01550861
Responsible party
Sponsor
First posted
Mar 12, 2012
Start date
Feb 15, 2012
Primary completion
Oct 15, 2022
Completion
Sep 18, 2023
Last update
Nov 18, 2023

Study contacts

Zev Rosenwaks, MD
principal investigator · Weill Cornell

Oversight

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

Not currently enrolling

This study is terminated, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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