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«PacifiCare’s medical management guidelines represent the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. They are ...»

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This information is being distributed to you for personal reference. The information belongs to UnitedHealthcare and unauthorized copying, use and distribution are prohibited. This information is intended to serve only as a general reference resource regarding our Medical Policies and is not intended to address every aspect of a clinical situation. Physicians and patients should not rely on these Medical Policies in making health care decisions. Physicians and patients must exercise their independent clinical discretion and judgment in determining care. The enrollee's specific benefit documents supersede these policies and are used to make coverage determinations. These Medical Policies are believed to be current as of the date noted.

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Description After evaluating relevant benefit document language (exclusions or limitations), refer to Coverage sections of this document to determine coverage.

This policy describes the use of cryopreservation technology to preserve sperm, semen, oocytes, embryos, ovarian tissue or testicular tissue at very low temperatures for use in reproduction at a later time.

Cryopreservation of Reproductive Tissue - Commercial Medical Management Guideline Coverage All reviewers must first identify member eligibility, any federal or state regulatory requirements and the plan benefit coverage prior to use of this policy.

Coverage Rationale Cryopreservation of sperm, semen or embryos is proven for individuals who are infertile or are planning to undergo therapies that threaten their reproductive health.

Cryopreservation of oocytes (eggs) is unproven. Although oocyte banking can be an option for women who have no partner at the time of cancer diagnosis, research indicates that unfertilized oocytes are more prone to damage during cryopreservation procedures than embryos, and as a result, the overall pregnancy rates may be lower than standard in vitro fertilization (IVF) procedures. New methods are developing rapidly; however, their use as a means to have a child after cancer treatment must be considered investigational and offered only with appropriate informed consent in a research setting and under the auspices of an institutional review board (IRB).

Cryopreservation of ovarian or testicular tissue is unproven. Ovarian tissue banking remains a promising clinical technique because it avoids ovarian stimulation and provides the opportunity for preserving gonadal function in prepubertal, as well as adult patients. However, this procedure has produced very few live births. Testicular tissue or testis xenografting are in the early phases of experimentation and have not yet been successfully tested in humans.

Cryopreservation services are subject to the limitations or exclusions of infertility benefits, if Benefit they exist, and if the individual has a diagnosis of infertility. In most Certificates of Coverage Considerations (COC) and Summary Plan Descriptions (SPD), storage after cryopreservation of sperm, oocytes (eggs), embryos or ovarian tissue is excluded, as it does not meet the definition of a covered health service. Some states mandate benefit coverage for certain infertility services.

Regulatory Requirements U.S. Food and Drug Administration (FDA): Products and media used for cryopreservation of reproductive tissue are too

numerous to list. See the following web site for more information (use product code MQL). Available at:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed March 20, 2009.

Research Evidence Background Cryopreservation is the process of cooling and storing cells, tissues or organs at very low or freezing temperatures to save them for future use. It is used to preserve sperm, semen, oocytes (eggs), embryos, ovarian tissue or testicular tissue as an option for men and women who wish to or must delay reproduction for various reasons, including the need to undergo therapies that threaten their reproductive health such as cancer treatment. Cryopreservation is also used to preserve unused gametes or zygotes produced through various artificial reproductive techniques for use at a later time.

Once frozen, cryopreserved tissues are stored at a variety of temperatures from -80 degrees celsius in a mechanical freezer to vapor (-100 degrees celsius) or liquid (-196 degrees celsius) phase liquid nitrogen. Expiration dates for cryopreserved tissues are generally 5 years, although these are arbitrary limits and the actual length of storage possible for many tissues has not been determined. (McPherson, 2007) Research In a meta-analysis, Oktay, et al. studied the efficiency of oocyte cryopreservation relative to in vitro fertilization (IVF) with unfrozen oocytes. Compared to women who underwent IVF after slow freezing (SF), IVF with unfrozen oocytes resulted in significantly better rates of fertilization. Although oocyte cryopreservation with the SF method appears to be justified for preserving fertility when a medical indication exists, its value for elective applications remains to be Cryopreservation of Reproductive Tissue - Commercial Medical Management Guideline determined. Pregnancy rates using a vitrification (VF) method appear to have improved, but further studies are needed to determine the efficiency and safety of this technique. (Oktay, 2006) Cyropreservation of oocytes and ovarian tissue represent uncertain efficacy at present. Access to such innovative techniques should be limited to carefully designed research settings where efficacy and outcomes can be assessed.

(FIGO, 2006) In an evidence-based report, the National Institute for Clinical Excellence (NICE) makes the following recommendations (NICE, 2004):

• Men and adolescent boys preparing for medical treatment that is likely to make them infertile should be offered semen cryostorage because the effectiveness of this procedure has been established.

• Women preparing for medical treatment that is likely to make them infertile should be offered oocyte or embryo cryostorage as appropriate if they are well enough to undergo ovarian stimulation and egg collection, provided that this will not worsen their condition and that sufficient time is available.

• Women preparing for medical treatment that is likely to make them infertile should be informed that oocyte cryostorage has very limited success, and that cryopreservation of ovarian tissue is still in an early stage of development.

Borini et al. studied the pregnancies and births in 68 women after undergoing assisted reproduction procedures for infertility problems using cryopreserved oocytes. Fifteen of the women became pregnant, there were 3 spontaneous abortions, and 13 healthy babies (one set of twins) were delivered. (Borini, 2004) Quintans reported on a series of in vitro fertilizations in twelve women using oocytes that had been cryopreserved in an alternative freezing medium. Six clinical pregnancies resulted, one of these was ectopic and three aborted spontaneously.

Two healthy babies were born. (Quintans, 2002) Professional Societies/Government Organizations

American Society for Reproductive Medicine (ASRM)/Society for Assisted Reproductive Technology (SART):

Semen samples may be frozen at a sperm bank or fertility center before starting chemotherapy or radiation therapy.

Samples can be stored for years and used later for insemination. Cryopreservation of eggs is investigational, expensive, invasive and may delay cancer treatment. If used, eggs are collected as for in vitro fertilization (IVF) but are frozen before they are fertilized. Theoretically, frozen eggs may be stored, thawed, fertilized and used for embryo transfer. Actual success with this method is very limited, and few babies have been born with this technique. (ASRM, 2004) Embryo banking is a proven method but requires both available sperm and several weeks of preparation. Oocyte banking avoids some of the disadvantages of embryo banking, although investigations of the application of this technology have been hampered historically by poor oocyte survival, fertilization and resulting pregnancy rates. Ovarian tissue banking remains a promising clinical technique because it avoids ovarian stimulation and provides the opportunity for preserving gonadal function in prepubertal, as well as adult patients. In the case of patients who are facing infertility due to chemotherapy, oocyte cryopreservation may be one of the few options available. It might therefore be acceptable under these circumstances with appropriate informed consent in an investigational protocol under the auspices of an IRB.

Although currently investigational, ovarian tissue cryopreservation and oocyte cryopreservation hold promise for future female fertility preservation, particularly following aggressive chemotherapy and/or radiotherapy treatment protocols.

(ASRM/SART, 2006) American College of Obstetricians and Gynecologists (ACOG): A number of techniques have been used to protect the ovaries and preserve fertility in women at risk of losing ovarian function prematurely as a consequence of cancer therapy.

In vitro fertilization (IVF) with cryopreservation of embryos is a proven method and is the most successful approach.

Ovarian tissue cryopreservation and oocyte cryopreservation are two options with the potential to preserve fertility.

Although these methods are developing rapidly, their use as a means to have a child after cancer treatment must be Cryopreservation of Reproductive Tissue - Commercial Medical Management Guideline considered investigational and offered only with appropriate informed consent in a research setting and under the auspices of an institutional review board. (ACOG, 2008) American Cancer Society (ACS) Preserving fertility in women (ACS, 2009): Embryo freezing is the most common and successful method of preserving fertility today. Mature eggs are removed from the woman's ovaries and fertilized in the lab via in vitro fertilization (IVF).

The embryos are then frozen for future use after successful cancer treatment. However, some women who have fastgrowing cancers cannot wait 2 to 3 weeks to begin treatment. Successful pregnancy rates vary from center to center.

Centers with the most experience usually have better success rates.

Egg freezing involves removing mature eggs with the same procedure used for embryo freezing, but the eggs are frozen without being fertilized. Few babies have been born (only around 150 worldwide) as a result of egg freezing, and the procedure remains investigational. This may be an option for women who have no partner at the time of cancer diagnosis, but egg freezing is not very reliable in producing pregnancy. The methods are improving, but the results are not as good as those with embryo freezing.

Ovarian tissue freezing involves surgically removing all or part of one ovary. The ovarian tissue is usually divided into small strips, frozen and stored to be transplanted back into the woman's body after treatment. Usually the eggs produced by the tissue would need to be collected and fertilized in the laboratory. In a few cases, the whole ovary has been frozen with the idea of transplanting it back. This procedure is experimental and has produced very few live births.

Preserving fertility in men (ACS, 2009): Sperm banking is an effective way for men who have gone through puberty to store sperm for future use. In sperm banking, one or more samples of semen are collected, tested, frozen and stored. The success rates of infertility treatments using frozen sperm vary and depend on the quality of the sperm after it is thawed. In general, sperm collected before cancer treatment is just as likely to start a pregnancy as sperm from men without cancer.

Sperm banking has resulted in thousands of pregnancies, without unusual rates of birth defects or health problems in the children. Once sperm is stored, it remains good for many years.

National Cancer Institute (NCI): Radiation therapy and chemotherapy treatments may cause temporary or permanent infertility. These side effects are related to a number of factors including the patient's sex, age at time of treatment, the specific type and dose of radiation therapy and/or chemotherapy, the use of single therapy or many therapies and length of time since treatment. Patients who are concerned about the effects of cancer treatment on their ability to have children should discuss this with their doctor before treatment. The doctor can recommend a counselor or fertility specialist who can discuss available options and help patients and their partners through the decision-making process. Options may include freezing sperm, eggs or ovarian tissue before cancer treatment. (NCI, 2006) American Society of Clinical Oncology (ASCO) Preservation of fertility in males (Lee, 2006): The available evidence suggests that sperm cryopreservation is an effective method of fertility preservation in males treated for cancer. In contrast, testicular tissue or spermatogonial cryopreservation and transplantation or testis xenografting are in the early phases of experimentation and have not yet been successfully tested in humans. Sperm cryopreservation is the most established technique for fertility preservation in men. Due to recent advances in in-vitro fertilization (IVF) technology and sperm banking procedures, even men with extremely reduced sperm count and motility are candidates for sperm cryopreservation.

Preservation of fertility in females (Lee, 2006): Fertility preservation options in females depend on the patient's age, type of treatment, diagnosis, whether she has a partner, the time available and the potential that cancer has metastasized to her ovaries. Embryo cryopreservation is considered an established fertility preservation method as it has routinely been used for storing surplus embryos after in vitro fertilization for infertility treatment. This approach typically requires approximately two weeks and may entail a delay in cancer treatment.

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