FAQs

Licensing

We are licensed by the Human Tissue Authority, who are the specialist UK government regulator for this work.

Is there any evidence for this technology?

Ovarian tissue cryopreservation, storage and transplantation has been undertaken for over 20 years in patients who are at risk of losing their fertility due to cancer or benign disease. There have been many medical-science publications on this technology for fertility preservation in these patients. The technology is the same for both fertility preservation and using this approach for extending the menopause. Given the success with fertility preservation we believe we are now in a position to offer the opportunity to postpone the menopause.

Guarantee

No medical procedure can offer a guarantee on outcome, but the chances of success have been presented in the medical-science literature, in our Patient Information Document and will depend upon individual circumstance, such as your age.

Risks

Is removing some ovarian tissue for storage, compromising the current or future function of the ovary?

Large studies which looked at the age of menopause for those having a whole ovary removed did not reveal any significant increase in the risk of early menopause.

Studies which looked at the long term follow up of patients having significant part of the two ovaries removed did not reveal significant risk of compromised ovarian function.

Approximately only 1% of the ovary is used for ovulation and there is an adjusting mechanism of the rate of the loss in the function of the ovary in case of surgical removal of part of the ovary.

ProFaM has developed a technique aiming to significantly eliminate this theoretical risk of compromising the ovarian function.  The technique entails:

  • Removal only of 1/3-1/2 of the outer layer of one of the 2 ovaries
  • Avoid use of any excessive ‘diathermy’ (the standard procedure of heating surrounding tissue to stop bleeding) which might compromise the remaining tissue
  • Removing only the outer layer which has very low blood supply to avoid any bleeding
  • Use of certain agent to minimise any risk of bleeding

Is there a risk of scar tissue formation which might affect the tube and the ability of spontaneous pregnancy?

There is no evidence that ovarian surgery affects the future ability to conceive.  We use the microsurgical principles through a key hole surgery which is known to reduce the risk of any scar formation significantly.

Is there a possibility that the frozen tissue will not survive after grafting back?

There is a small possibility that the tissue will not survive after transferring it back.  It has been estimated that the risk is 5-10%, but much of this information is based patients who already had health risks; not young, healthy patients.  Therefore, the potential for any risk could be explained by many factors (which will be discussed at consultation).  We advise you to have your stored tissue grafted back in 2-3 episodes where possible, which will significantly reduce such risk.

Is there a risk of loss of the eggs because of the cut of blood supply or freezing?

The risk of cutting blood supply is very low, but should this happen, or there is an effect of freezing, you will end up losing some of the follicles existing in the tissue.  However, depending upon your age there should be a large number of follicles so you will still have enough follicles to function as normal

What are the risks of laparoscopy?

The laparoscopy (key hole surgery) is commonly performed and quite a safe procedure.  The risk of the procedure depends on many factors which requires medical assessment. 

Minor complications are estimated to occur in 1 to 2 out of every 100 women. These are usually self-limiting and resolving, including shoulder tip pain, wound infection or minor bruising.

Serious complications are estimated to occur in 1 out of 1000 cases. 

These include: injury to the bowel or blood vessel. This injury can be fixed through the laparoscopy or through a bigger cut. There is very remote risk of clotting in the leg or the lung, and appropriate preventive measures will be taken to reduce significantly such risks.

All The risks will be outlined in the laparoscopy leaflet.

 

How long will I need to rest after the procedure?

The duration of surgery is about 45 minutes. Your total time spent in the hospital will be about half a day. You will go home on the same day. Some patients may elect to stay in the hospital Executive rooms (at additional cost), but this is optional. The recovery time required before either resuming normal activities (or for those initiating chemotherapy or radiation therapy is expected to be 2-3 days). You will not be able to drive for a few days following the procedure. If you are planning to have surgery for other reasons, either by keyhole or a bigger cut on your abdomen (for example, a caesarean section), the procedure to remove some ovarian tissue can be done at the same time with no added risk to yourself.

When is it best to do this?

The younger the better!

Women are born with around 2 million eggs in their ovaries, which reduce in number to about 400,000 when they reach puberty. When a woman ovulates (releases an egg), usually one per month, many eggs develop along with the one that is ovulated but they deteriorate before ovulation (about 10,000 die every month).

Eventually, when a woman approaches her menopause, there are very few eggs left in the ovary, and this brings about the menopausal state. So during a woman’s fertile period all the eggs ovulated will have been in the ovary since before birth.

It is well established that as a woman ages not only do the number of the eggs decline but also their quality; and by ‘quality’ we usually mean the stability of their chromosomes. This is the reason why the chance of Down Syndrome increases with age, for example the chance of an egg carrying the extra chromosome for Down Syndrome at age 32 is 1/725, but at 40 this increases to 1/100. This is also the main reason miscarriage increases with age, from about 12% at 34 to 42% at age 40.

What’s my risk of being pregnant late in life when I only want hormones?

For hormone replacement use of the tissue only we have various strategies to ensure that you will not become pregnant, which does not involve taking drugs or medicines. For example, the tissue can be grafted back to an area from which it is not possible to conceive, but hormone production remains uninhibited.

What if I want the hormones from my transplanted ovaries to delay my menopause but I don’t want periods?

Periods can be prevented, again without the need of drugs, and this needs to be fully discussed with your specialist.

If I want to get pregnant will I need IVF?

From the many cases done over the years, the data indicates that around 50% of patients can conceive naturally, whilst the remainder will need IVF.

Where is my tissue grafted back?

This depends upon individual circumstances, and as there are a number of options. Your particular situation needs to be discussed with your consultant.

How early should I freeze my ovarian tissue and what are the implications of my age on egg quality?

The younger the tissue is frozen the better in terms of egg quality and the longer the menopause can be delayed. Age 25-30 is optimal, but it can be done at any time with expected good results up to 37.

The older you are, especially past 35 but starting at 32, the quality of your eggs declines, with increasing risk of chromosomal abnormality in many of the eggs and that increases the risk of a chromosomal anomaly resulting in the baby; see table below:

Maternal Age
(at Delivery)
% of Eggs with Chromosome Problem Risk of Chromosome
Error in Liveborn Child
30 35% 1 in 385 (or 0.26%)
35 50% 1 in 192 (or 0.52%)
40 70% 1 in 66 (or 1.5%)
45 >80% 1 in 21 (or 4.8%)
49 >90% 1 in 8 (or 12.5%)

What is laparoscopy?

Laparoscopy refers to a procedure performed by an experienced specialist surgeon. It involves the use of a thin telescope-like instrument (a laparoscope) that is inserted into your abdomen through a small incision (only about 1cm) just below your navel.

Two or three other such incisions may be made to permit the introduction of other instruments into your abdomen to allow the removal of a piece of your ovary. The technique for the removal of the ovarian tissue by the laparoscopy is based on well-established surgical approaches or techniques and has a very high likelihood of success.

Is ProFaM for Everyone

ProFaM is not for everyone, and not for those who are already in the menopause because that means the biological clock has happened, the ovary has ceased to function and we cannot reverse that. ProFaM is also not for those who are close to the menopause for the same reason; when we freeze the tissue, we preserve it at that moment in time. If the ovary was programmed to go into the menopause a year later, the maximum opportunity for a delay a year, or less.

The very best opportunity is when a woman is young as the tissue is destined to last many years or one or two decades more. As a general rule ProFaM patients will ideally be under 36. Our advice will be up to 35 for fertility preservation and possibly up to 40 for hormonal preservation. However, any final decision can only be taken after a few ‘ovarian reserve’ tests are undertaken, following a consultation. These tests involve hormone evaluation and an ultrasound scan of the ovary.   

ProFaM is designed for different groups of patients including cancer patients; those with benign but severe conditions that require pelvic surgery (such as non-cancerous ovarian tumours, those suffering from a torsion or severe endometriosis); endocrine and genetic conditions or autoimmune disorders.

ProFaM is also intended for ‘opportunistic’ conditions – such as those patients who have elective caesarean section or other pelvic surgery when at the same time a small portion of the ovary can be removed.

University of Birmingham CAREfertility