Trial · Interventional

CompletedNot applicableResults postedRegistry data

Investigational Oocyte Cryopreservation for Medical and Non Medical Indications

NCTNCT04616417Other id2012-0233

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Names hCG (human chorionic gonadotropin), does not test it. It appears in the description.

Overview

Status: Completed
Phase: Not applicable
Enrollment: 29 participants (actual)
Sponsor: University of Illinois at Chicago · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: 8 May 2015
Primary completion: 20 Mar 2023
Completion: 20 Mar 2023
First posted: 5 Nov 2020
Last update posted: 30 Jul 2024
Conditions: Infertility, Female · Deferred Childbearing

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20162018202020222024

N/A
Investigational Oocyte Cryopreservation for Medical and Non Medical Indications
NCT04616417
8 May 2015 to 20 Mar 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

Investigational Oocyte CryopreservationProcedure

Arms1

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.

Primary outcomes4

Outcomes the sponsor listed as primary.

Fertility Quality of Life Questionnaire Completed After One Year After Oocyte Cryopreservation for Non-medical Reasons
Time frame · Fertility quality of life questionnaire completed after one year after oocyte cryopreservation
Registry description
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. FertiQol is scored based on the standards of the assessment tool in a quantitative manner. Only 9 patients completed the this questionnaire. FertiQoL consists of 36 items that assess core (24 items) and treatment-related (10 items) quality of life as well as overall life and physical health (2 items). Higher scores indicated better outcomes and lower scores indicated worse outcomes on this questionnaire.
Structured Clinical Interview Completed After One Year After Oocyte Cryopreservation for Non-medical Reasons
Time frame · structured clinical interview completed after one year after oocyte cryopreservation
Registry description
Study participants will be contacted on an annual basis using the "Investigational Oocyte Cropreservation Follow-up Call Script/structured interview" to determine any subsequent attempts to utilize the stored oocytes for the purpose of initiating a pregnancy, along with the outcome of the attempt. Only 9 patients completed this interview. There was not score assigned to this interview.
Fertility Quality of Life Questionnaire Completed After One Year After Oocyte Cryopreservation for Cancer Patients
Time frame · Fertility Quality of Life Questionnaire Completed After One Year After Oocyte Cryopreservation for cancer patients
Registry description
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. FertiQol is scored based on the standards of the assessment tool in a quantitative manner. only one cancer patient completed this questionnaire.FertiQoL consists of 36 items that assess core (24 items) and treatment-related (10 items) quality of life as well as overall life and physical health (2 items). Higher scores indicated better outcomes and lower scores indicated worse outcomes on this questionnaire.
Structured Clinical Interview Completed After One Year After Oocyte Cryopreservation for Cancer Patients
Time frame · Structured Clinical Interview Completed After One Year After Oocyte Cryopreservation for cancer patients
Registry description
study participants will be contacted on an annual basis using the "Investigational Oocyte Cropreservation Follow-up Call Script/structured interview" to determine any subsequent attempts to utilize the stored oocytes for the purpose of initiating a pregnancy, along with the outcome of the attempt. only 1 cancer patient completed this structured interview. There was not score assigned to this interview.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· Fertility quality of life questionnaire completed after one year after oocyte cryopreservation

Fertility Quality of Life Questionnaire Completed After One Year After Oocyte Cryopreservation for Non-medical Reasons

Group	Value (Participants)
Investigational Oocyte Cryopreservation	9

Primary outcomeCount of participants· structured clinical interview completed after one year after oocyte cryopreservation

Structured Clinical Interview Completed After One Year After Oocyte Cryopreservation for Non-medical Reasons

Group	Value (Participants)
Investigational Oocyte Cryopreservation	9

Primary outcomeCount of participants· Fertility Quality of Life Questionnaire Completed After One Year After Oocyte Cryopreservation for cancer patients

Fertility Quality of Life Questionnaire Completed After One Year After Oocyte Cryopreservation for Cancer Patients

Group	Value (Participants)
Investigational Oocyte Cryopreservation	1

Primary outcomeCount of participants· Structured Clinical Interview Completed After One Year After Oocyte Cryopreservation for cancer patients

Structured Clinical Interview Completed After One Year After Oocyte Cryopreservation for Cancer Patients

Group	Value (Participants)
Investigational Oocyte Cryopreservation	1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Investigational Oocyte CryopreservationAll 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. Investigational Oocyte Cryopreservation: Transvaginal oocyte retrieval under ultrasound guidance	0 / 29	0 / 29	0 / 29

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 40 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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

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