Back to results

Investigational Oocyte Cryopreservation for Medical and Non Medical Indications

Primary Purpose

Infertility, Female, Deferred Childbearing

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Investigational Oocyte Cryopreservation

About this trial

This is an interventional supportive care trial for Infertility, Female

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Women aged >18 and < 40years
Women able to defer definitive cancer therapy for 21 to 30 days
Women diagnosed with cancer or any disease whose treatment or its progression may impair their reproductive potential (this would include but not be limited to cancer patients requiring treatment with chemotherapy or radiation, patients with rheumatologic diseases such as lupus, rheumatoid arthritis and ulcerative colitis and patients with genetic predisposition to cancers
Women undergoing standard In Vitro Fertilization to treat infertility who experience unforeseen events that halts the treatment cycle
Women seeking oocyte cryopreservation for non medical reasons, such as deferred childbearing
Women who are carriers of BRCA mutations predisposing them to cancer
Otherwise healthy females
Ability and willingness to comply with study protocol
Informed written consent, prior to any study-related procedure not part of normal care, with the understanding that the subject may withdraw consent at any time without prejudice to their future medical care

Exclusion Criteria:

Current pregnancy
Serum FSH > 10 mIU/ml for patients having egg freezing for a medical indication
Serum FSH > 10 mIU/ml for patients having egg freezing for social reasons
Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent (Post Traumatic Stress Disorder, severe depression, bipolar disorder, schizophrenia, severe anxiety and inability to cope)
Patients with extensive disease whose therapy is deemed palliative by the medical oncologist

Sites / Locations

University of Illinois Hospital & Health Sciences System - IVF Program in the Fertility Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Investigational Oocyte Cryopreservation

Arm Description

All subjects will undergo controlled ovarian hyperstimulation. They will be treated with variable dosages of injectable gonadotrophins over a period of 8 to 12 days. Response will be monitored using vaginal ultrasound and serum estradiol levels. When appropriate follicle maturation has been achieved, a single dose of human chorionic gonadotropin (hCG) will be administered to induce final oocyte maturation. Thirty-six hours after hCG administration, the subject will undergo standard transvaginal oocyte retrieval under ultrasound guidance. The procedure takes approximately 20 minutes and is carried out under conscious sedation with Fentanyl and Versed. The oocytes are immediately handed off to the embryology technicians in the IVF laboratory.

Outcomes

Primary Outcome Measures

Assessing the impact of the process of oocyte cryopreservation

Fertility focused quality of life questionnaire (FertiQol)

Assessing the impact of the process of oocyte cryopreservation

Structured interview

Assessing the comparison between cancer patients and women for non-medical undergoing oocyte cryopreservation

Fertility focused quality of life questionnaire (FertiQol)

Assessing the comparison between cancer patients and women for non-medical undergoing oocyte cryopreservation

Structured interview

Secondary Outcome Measures

Full Information

NCT ID

NCT04616417

First Posted

October 30, 2020

Last Updated

March 20, 2023

Sponsor

University of Illinois at Chicago

1. Study Identification

Unique Protocol Identification Number

NCT04616417

Brief Title

Investigational Oocyte Cryopreservation for Medical and Non Medical Indications

Official Title

Investigational Oocyte Cryopreservation for Medical and Non Medical Indications

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

May 8, 2015 (Actual)

Primary Completion Date

March 20, 2023 (Actual)

Study Completion Date

March 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Illinois at Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Detailed Description

This is a prospective study to assess the long term benefits and outcomes of the existing oocyte cryopreservation methods for fertility preservation in women with a potential medical or non medical risk of loss of fertility. Women wishing to preserve their oocytes using cryopreservation will be informed of the risk and limitations of the procedures involved in ovarian hyperstimulation, oocyte recovery, cryopreservation and subsequent viability after warming. Women who consent to the procedure will undergo standard controlled ovarian hyperstimulation (COH) and oocyte retrieval procedures currently in use for IVF. Following harvest all eggs obtained will be evaluated for degree of fragmentation and maturation status. The oocytes will be cryopreserved using kits of media and devices currently approved for use in the vitrification of fertilized eggs and embryos, and the cryopreserved oocytes will be stored for future patient use in a long term storage facility in Minnesota (Reprotech Ltd.). Patients with stored oocytes will be contacted annually to determine the outcome of any oocyte warming procedures (oocyte thawing, fertilization and embryo transfer). We will obtain a structured fertility focused quality of life questionnaire (FertiQol) and survey to assess one year after harvest the impact of the process. We will compare cancer patients to those patients undergoing oocyte cryopreservation for non-medical reasons

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility, Female, Deferred Childbearing

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Investigational Oocyte Cryopreservation

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Investigational Oocyte Cryopreservation

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Investigational Oocyte Cryopreservation

Intervention Description

Transvaginal oocyte retrieval under ultrasound guidance

Primary Outcome Measure Information:

Title

Assessing the impact of the process of oocyte cryopreservation

Description

Fertility focused quality of life questionnaire (FertiQol)

Time Frame

1 year

Title

Assessing the impact of the process of oocyte cryopreservation

Description

Structured interview

Time Frame

1 year

Title

Assessing the comparison between cancer patients and women for non-medical undergoing oocyte cryopreservation

Description

Fertility focused quality of life questionnaire (FertiQol)

Time Frame

1 year

Title

Assessing the comparison between cancer patients and women for non-medical undergoing oocyte cryopreservation

Description

Structured interview

Time Frame

1 year

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women aged >18 and < 40years Women able to defer definitive cancer therapy for 21 to 30 days Women diagnosed with cancer or any disease whose treatment or its progression may impair their reproductive potential (this would include but not be limited to cancer patients requiring treatment with chemotherapy or radiation, patients with rheumatologic diseases such as lupus, rheumatoid arthritis and ulcerative colitis and patients with genetic predisposition to cancers Women undergoing standard In Vitro Fertilization to treat infertility who experience unforeseen events that halts the treatment cycle Women seeking oocyte cryopreservation for non medical reasons, such as deferred childbearing Women who are carriers of BRCA mutations predisposing them to cancer Otherwise healthy females Ability and willingness to comply with study protocol Informed written consent, prior to any study-related procedure not part of normal care, with the understanding that the subject may withdraw consent at any time without prejudice to their future medical care Exclusion Criteria: Current pregnancy Serum FSH > 10 mIU/ml for patients having egg freezing for a medical indication Serum FSH > 10 mIU/ml for patients having egg freezing for social reasons Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent (Post Traumatic Stress Disorder, severe depression, bipolar disorder, schizophrenia, severe anxiety and inability to cope) Patients with extensive disease whose therapy is deemed palliative by the medical oncologist

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sana Salih, MD

Organizational Affiliation

University of Illinois at Chicago

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Illinois Hospital & Health Sciences System - IVF Program in the Fertility Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Investigational Oocyte Cryopreservation for Medical and Non Medical Indications

We'll reach out to this number within 24 hrs