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

45 Years
Open (Enrolling)
Cancer, Risk of Premature Ovarian Failure, Fertility Preservation

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Trial Information

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

Procedure: The patient will undergo preoperative sonographic assessment of both ovaries to
determine if either ovary is diseased or compromised. Patient will undergo preoperative
blood sampling to measure AMH, FSH, LH and estradiol as indicators of current ovarian
function (less than 8 teaspoons) if time allows and assessment of ovarian reserve is
appropriate; menopausal levels of FSH (≥ 30 miu/ml) will be a contraindication to
participation in this study. The patient may have infectious disease testing as part of the
evaluation for fertility preservation treatment. Patient will undergo preoperative
assessment and clearance for surgery by an anesthesiologist.

Intraoperative management will include laparotomy or laparoscopy, depending on the
individual patient's history, exam and oncology plans. Removal of one or both ovaries will
depend on preoperative ovarian assessment and recommendation of the oncologist. If ovarian
survival for the anticipated treatment has never been documented then both ovaries will be
removed. Both ovaries may also be removed if diseased or if the condition requires
prophylactic oophorectomy to prevent risk of malignant transformation, e.g. 46 XX/46 XY
chimera and BRCA mutation carriers. If ovarian function has rarely been documented for the
anticipated treatment then one ovary will be removed and one may be left in situ or
repositioned to avoid the field of radiation. The decision to leave the ovary in situ or to
reposition will be made pre-operatively by the physician performing the surgery in
consultation with the patient and the radiation oncologist. If there is no normal ovarian
tissue, as determined by pathology, we will take biopsies of ovarian tissue not to exceed
50% of the ovarian volume from the contra-lateral side for freezing. Additionally, the
remaining ovary may be repositioned and sutured to the posterior wall of the uterus or above
the pelvic brim with a radio-opaque clip placed to identify this ovary for shielding during

Ovarian tissue will be removed and treated as follows: (a) the cortex will be stripped from
the remaining ovarian tissue as this outer layer contains most of the immature eggs or
primordial follicles. The cortex will be sectioned into 8mm x 1mm strips, each to be frozen
in vials containing 1-3 strips. One strip will be sent to pathology for paraffin embedding
to be available for future assessment of occult lymphoma cells markers; (b) the central or
medullary portion will be frozen separately for potential scientific analysis since this
section would not be of any clinical utility. The amount of tissue frozen may vary depending
in part by whether one or two ovaries are removed. At some point in the future, thawing of
ovarian tissue, with either in vitro maturation or autologous transplantation into the
pelvis or other area of the body could be performed. The patient would receive routine
postoperative care. The patient's oncologist will be consulted regarding proper timing of
the surgery and the need for any special intraoperative or postoperative management

However, since the survival of the primordial follicles in transplanted ovarian tissue is
quite low (<10%), methods for in vivo maturation of these eggs and improved methods of
transplantation need to be developed. One or two vials of tissue (<10% of all tissue frozen)
will be thawed to develop the techniques of maturing oocytes. This may include
transplantation of the tissue into an animal model for in vivo maturation.

Six months to 1 year following surgery and/or treatment for the medical condition, eg
chemotherapy, hormone testing will be performed for evaluation of ovarian reserve. This may
include AMH and FSH hormone levels as well as pelvic ultrasounds and dominant antra
follicle count.

If the subject does not wish to utilize the ovarian tissue for her own clinical use, the
options include discarding the cryopreserved ovarian tissue or donating the cryopreserved
tissue for approved research studies.

Inclusion Criteria:

- Females 0-45 years of age who are premenopausal

- Treatment plan that will likely result in premature menopause or premature ovarian

- This includes patients receiving:

- Cancer treatment with abdominal pelvic irradiation and/or high dose chemotherapy

- Surgery that requires removal of ovaries for medical condition or disease, e.g.
Prophylactic oophorectomy in BRCA patients

- Patient is unable or unwilling to pursue fertility preservation by freezing oocytes
or embryos.

- Previous treatment for cancer is acceptable if patient still has ovarian function

- Patient is medically stable enough to undergo surgery (cleared for anesthesia)

Exclusion Criteria:

- Patients not meeting the above criteria

- Patients who have not received medical clearance from their physicians to undergo

- Patients already experiencing menopause.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:


Outcome Description:

Ovarian tissue cryopreservation Survival of tissue undergoing cryopreservation, thawing and maturation of immature eggs.

Outcome Time Frame:

6 months to a year post surgery, hormone testing will be performed to test ovarian function.

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

April 1997

Completion Date:

October 2015

Related Keywords:

  • Cancer
  • Risk of Premature Ovarian Failure
  • Fertility Preservation
  • Ovarian tissue cryopreservation
  • Ovarian tissue transplantation
  • Fertility preservation
  • Risk of premature ovarian failure
  • Menopause, Premature
  • Primary Ovarian Insufficiency



Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine New York, New York  10021