In Vitro Maturation (IVM) of Human Oocytes | NCT01550861

Studies
In Vitro Maturation (IVM) of Human Oocytes

NCT01550861

Sponsor

Weill Medical College of Cornell University

Status

Terminated

Last Update Posted

Nov 18, 2023Actual

Enrollment

2Actual

Phase

Not Applicable

Conditions

Infertility

Interventions

in vitro maturation
Polar Body Biopsy with preimplantation genetic screening

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low accrual

Expanded Access Info

Start Date

Feb 15, 2012Actual

Primary Completion Date

Oct 15, 2022Actual

Completion Date

Sep 18, 2023Actual

First Submitted Date

Feb 16, 2012

First Submission Date that Met QC Criteria

Mar 7, 2012

First Posted Date

Mar 12, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2023

Last Update Posted Date

Nov 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
In vitro Maturation	Experimental	in vitro maturation of immature oocytes	Procedure: in vitro maturation Procedure: Polar Body Biopsy with preimplantation genetic screening

Interventions

Name	Type	Description	Arm Group Labels	Other Names
in vitro maturation	Procedure	Maturation of immature oocytes in the laboratory following oocyte retrieval	In vitro Maturation

Measure	Description	Time Frame
number of oocytes retrieved and embryos generated		1 year

Measure	Description	Time Frame
live birth rate		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

42 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zev Rosenwaks, MD	Weill Cornell	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Reproductive Medicine- Weill Cornell Medical College		New York	New York	10021	United States

Label	URL
Center for Reproductive Medicine- Weill Cornell Medical College	View source

ID	Term
D007246	Infertility

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D059471	In Vitro Oocyte Maturation Techniques

Ancestor Terms

ID	Term
D027724	Reproductive Techniques, Assisted
D012099	Reproductive Techniques
D013812	Therapeutics
D008919	Investigative Techniques

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Browse Branches

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