Fertility preservation is making its place with various indications. In fact fertility preservation is  fertility insurance for future. With the advancement of science and emerging diseases, fertility preservation seems to be a rights for everyone. Moreover it must be 100 % safe from any future upcoming dangers. The recent technology of fertility preservation is freezing of either egg or sperm.  Also part of ovary or testicle (gonads) can be preserved.  But here is a question.  Are we executing 100% safe fertility preservation?  Answer is “NO”.

The main reason behind this “NO” is use of human serum albumin(H.S.A.) or any other biological products. Biological product are – which is derived either from human or any living/dead organism.  At present we are using H.S.A. routinely to freeze ova and egg or flakes of gonads.  Many researchers studied with fetal bovine serum (F.B.S), milk protein, egg yolk  etc.  Everything, which originate from living or dead organism involve a risk of disease transmission.

H.S.A. — Human Serum Albumin

When to go for fertility preservation:–

  1. Cancer treatment resulting in premature ovarian insufficiency in female or sterility in male.

  2. Removal of gonads.

  3. Late marriage.

  4. Distant job of partner.

  5. Some high risk job.

  6. Mind change after sex change.

  7. Following accidents fertility preservation is on demand to maintain biological bloodline.

  8. Above all donor’s gamete preservation. which demand is increasing.

Our this discussion will focus on following  points of fertility preservation  —–

  1. Current method of fertility preservation.

  2. Is it safe to preserve fertility by using any biological product?

  3. How to make fertility preservation safe?

Current method of fertility preservation

In current method of fertility preservation,  we add cryo-preservative medium with raw or prepared gametes or gonads.  Followed by keeping the substance  in liquid nitrogen at ultra low temperature (- 196 degree C). At this temperature activity of cell seizes. Therefore cell , gamete or even tissue can be kept for indefinite period.

Cryo-preservative medium contain different chemicals to make it isotonic  and provide suitable environment.  Additionally it contain cryo- protectant to keep cells alive at ultra  low temperature. Additionally almost all cryo-preservative medium contain H.S.A.. Which role in simplest  word is to provide nutrition, give better post thaw recovery and motility.  There are may claims that H.S.A. also improve end result.

Is it safe to preserve fertility by using any biological product?

Any biological product have capacity to infect. Here I mention that all commercially available cryo-preservative medium have H.S.A.. Which composition and all constituents are still unclear.  There is also batch to batch variation in composition. Role of H.S.A. are also not clear. It may provide nutrition, carrier of some hormones,  provide a smooth environment to swim the sperm or act as antioxidant.  It is also supposed to responsible for membrane permeability. Moreover H.S.A. also may have some enzymatic activity. But still it is not clear that these roles have more benefit or damage.

Any detail studies of patients/volunteers  are not currently available for an accurate assessment of damage attributable to H.S.A. added sperm preservation.

H.S.A. is treated by Cohn method + liquid chromatography to make it safe. The currently used  process is effective in eradicating known virus. There is fair possibility that unknown infectious agents may be present in such products. Moreover some viruses may develop resistance with the presently used pasteurization process. Or even worst un-diagnosed or emerging virus may come up with resistance to sterilization method.

Human serum albumin is being obtained from chain of donors. Therefore there is always a risk of disease transmission.  Although human serum albumin supplier claim that they took all possible measures  to make H.S.A. disease free. But somewhere errors are unavoidable.

Even transportation may be a reason of contamination.  Other man made mistake is also a point to consider. An incidence of multi state outbreak of E. cloacae reported in Japan caused by contaminated albumin product.  Link

Presently we are not capable  to detect emerging and un-diagnosed virus.  Therefore transmission of emerging and un-diagnosed virus is a striking possibility.

Certain Disease like CJD (Creutzfeldt–Jakob disease)  cannot be diagnosed in early stage and can be transmitted.

Human serum albumin  also have some endotoxins. The raw material for H.S.A  is human serum. Which have many safety limitation. As well it may have religious & ethical issue.

How to make fertility preservation safe.

Fertility preservation safety measures must commence with source. Mainly sources are   —

  1. Gametes or part of gonads.  — Individual should be screened always with  updated standard. Secondly they should be retested after a defined period.

  2. Compounds used to preserve fertility —  In perfection compound used  should not have any component of biological origin.  In case it have biological product its safety will always remain in doubt.

  3. Sterility of plastic disposable — Sterility of plastic disposables granted by different sterilization method. Best way is in house sterilization.

Discussion

Repeatedly we are experiencing new viruses like HIV, zika, swine flu, ebola, corona virus. They are getting more infectious & dreadful. More zoonotic  disease are infecting human.  Which diagnosis and treatment are a grave challenge to modern science.

Our knowledge and science is not in condition to say that they can detect all up-coming viruses. It is possible that we are able to see only tip of iceberg.

There is a fair possibility that biological product we are using to preserve fertility is infected by some un-diagnosed virus.  And in future preserved material is of no use or we have to discard it.

Conclusion

We end up this topic with the conclusion that use of biological product should be discouraged in case of fertility preservation.

The ultimate aim of our organization “Frozen Cell” is to make infertility management safe and practical at all level

Conflict of interest

As of now we did not encounter any conflict on this study. Rather we invite conflict & critics. Therefore we are always open to any discussion

Ethical Issue

Not applicable

Funding

The whole study conducted by our own resources.  We did not receive any grant or assistance from any organization.

Acknowledgement

We are thankful to our whole team of Frozen Cell for their supportive approach and co-operation.

References

  1. Overview of albumin & its purification method,  https://www.researchgate.net/publication/311375542

  2. Enterobacter cloacae Bloodstream Infections Traced to Contaminated Human Albumin, https://academic.oup.com/cid/article/30/1/35/323315

  3. American Society of Clinical Oncology (ASCO). (2013). Fertility preservation. Retrieved May 31, 2016, from http://www.cancer.net/research-and-advocacy/asco-care-and-treatment-recommendations-patients/fertility-preservation

  4. Loren, A. W., Mangu, P. B., Beck, L. N., Brennan, L., Magdalinski, A. J., Partridge, A. H., et al. (2013). Fertility preservation for patients with cancer: American Society of Clinical Oncology clinical practice guideline update. Journal of Clinical Oncology, 31(19), 2500–2510.

  5. ASCO. (2016). Fertility concerns and preservation for men. Retrieved May 31, 2016, from http://www.cancer.net/navigating-cancer-care/dating-sex-and-reproduction/fertility-concerns-and-preservation-men

  6. National Cancer Institute. (n.d.). NCI dictionary of cancer terms: Ovarian transposition. Retrieved January 13, 2017, from https://www.cancer.gov/publications/dictionaries/cancer-terms?cdrid=780385

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