Actively Recruiting

Phase Not Applicable
Age: 0 - 45Years
FEMALE
ID01558544

Cryopreservation of Ovarian Tissue for Potential In Vitro Maturation or Autologous Transplantation

Led by Weill Medical College of Cornell University · Updated on 2025-12-10

300

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the freezing and thawing of ovarian tissue and the in vitro maturation of immature eggs to help people at risk for premature ovarian failure conceive genetically related children. This research focuses on females up to 45 years old who are premenopausal and facing treatments or conditions that may cause early menopause or ovarian failure, such as cancer therapies or surgeries removing ovaries. The study aims to develop better technologies for preserving fertility in these patients. Participants will undergo preoperative assessments including ultrasound of the ovaries, blood tests to measure hormone levels, and clearance for surgery. Depending on individual evaluation, one or both ovaries may be surgically removed using laparotomy or laparoscopy. The ovarian tissue will be processed, with the cortex separated and frozen in strips for possible future use. Some tissue may be thawed later to develop egg maturation techniques, potentially using animal models. Postoperative care will be provided, and the timing of surgery will be coordinated with the patient's oncologist. During follow-up, hormone tests such as AMH and FSH levels, along with pelvic ultrasounds, will be performed 6 months to 1 year after surgery to evaluate ovarian reserve and function. Participants may choose to use, discard, or donate their frozen ovarian tissue for research. The main outcome measured is ovarian function after cryopreservation and potential maturation or transplantation. The study involves routine assessments and hormone testing over the course of up to a year following surgery or treatment.

CONDITIONS

Brief Title

Cryopreservation of Ovarian Tissue

Who Can Participate

Age: 0 - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged 0 to 45 years who is premenopausal
  • Treatment plan likely to cause premature menopause or ovarian failure
  • Receiving cancer treatment with abdominal pelvic irradiation and/or high dose chemotherapy
  • Surgery planned that requires removal of ovaries for medical reasons, such as prophylactic oophorectomy in BRCA patients
  • Unable or unwilling to preserve fertility by freezing eggs or embryos
  • Previous cancer treatment allowed if ovarian function remains
  • Medically stable and cleared for anesthesia and surgery
Not Eligible

You will not qualify if you...

  • Not meeting the inclusion criteria
  • Not medically cleared by a physician to undergo surgery
  • Already experiencing menopause

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Surgery

Duration - Day of surgery

Participants undergo surgery to remove one or both ovaries depending on their condition and treatment plan. This surgery may involve laparotomy or laparoscopy and includes removal and cryopreservation of ovarian tissue.

1 surgery visit (in-person)

Post-operative Follow-up

Duration - Weeks to months following surgery

Participants receive routine postoperative care following ovarian tissue removal surgery.

Approximately 1 to 2 follow-up visits

Long-term Monitoring

Duration - 6 months to 1 year

Six months to one year after surgery and/or treatment, participants undergo hormone testing and pelvic ultrasounds to evaluate ovarian reserve and function.

1 to 2 visits for hormone testing and ultrasounds

Trial Site Locations

Total: 1 location

1

Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine

New York, New York, United States, 10021

Actively Recruiting

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Research Team

R

Rodriq E. Stubbs, NP

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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