Investigational Oocyte Cryopreservation for Medical and Non Medical Indications

Sponsor

University of Illinois at Chicago (Other)

Overall Status

Recruiting

CT.gov ID

NCT04616417

Collaborator

(none)

Enrollment

Location

Arm

181.8

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female Deferred Childbearing	Procedure: Investigational Oocyte Cryopreservation	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Investigational Oocyte CryopreservationInvestigational Oocyte Cryopreservation

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Investigational Oocyte Cryopreservation for Medical and Non Medical Indications

Actual Study Start Date :

May 8, 2015

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Investigational Oocyte Cryopreservation 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.	Procedure: Investigational Oocyte Cryopreservation Transvaginal oocyte retrieval under ultrasound guidance

Arm

Intervention/Treatment

Experimental: Investigational Oocyte Cryopreservation

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.

Procedure: Investigational Oocyte Cryopreservation

Transvaginal oocyte retrieval under ultrasound guidance

Outcome Measures

Primary Outcome Measures

Assessing the impact of the process of oocyte cryopreservation [1 year]
Fertility focused quality of life questionnaire (FertiQol)
Assessing the impact of the process of oocyte cryopreservation [1 year]
Structured interview
Assessing the comparison between cancer patients and women for non-medical undergoing oocyte cryopreservation [1 year]
Fertility focused quality of life questionnaire (FertiQol)
Assessing the comparison between cancer patients and women for non-medical undergoing oocyte cryopreservation [1 year]
Structured interview

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Illinois Hospital & Health Sciences System - IVF Program in the Fertility Center	Chicago	Illinois	United States	60612

Sponsors and Collaborators

University of Illinois at Chicago

Investigators

Principal Investigator: Sana Salih, MD, University of Illinois at Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sana Salih, Principal Investigator, University of Illinois at Chicago

ClinicalTrials.gov Identifier:

NCT04616417

Other Study ID Numbers:

2012-0233

First Posted:

Nov 5, 2020

Last Update Posted:

Oct 29, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infertility

Infertility, Female

Study Results

No Results Posted as of Oct 29, 2021