The BMS medical advisory council has issued a response to the recent coverage on delaying the menopause:
A number of media outlets have reported this week on the launch of a procedure that is intended to delay the menopause by offering women cryopreservation (freezing) of their ovarian tissue with the intention of subsequently replacing the tissue to provide hormones to counteract the adverse effects of the menopause.
The media release by the company reported on nine women who had undergone the procedure. The ovarian tissue biopsies were obtained through a keyhole surgical procedure (laparoscopy), then frozen and subsequently re-implanted after the woman’s menopause with the intention of providing the woman with her own ovarian hormones.
The procedure in principle is not new and has now been used for a number of years in young women at risk of losing their ovarian function as a result of cancer treatment. The focus in such cases is replacing the women’s eggs to restore fertility. There have been to date more than 100 children born as a result of this technique and many of the reports have indicated that the ovarian tissue grafts result in hormonal activity.
There are a number of limitations to this procedure that need to be further assessed before considering this technique in standard clinical practice that is intended to delay the menopause.
These include the following:
1. The company report on the procedure included a small sample of nine women with no long-term reporting on the safety of this technique to delay the menopause or how effective it is.
2. The report suggests that this treatment ‘can delay the menopause by 20 years’. However, the series does not appear to include long-term follow up information to support this conclusion.
This is particularly relevant as research on the use of this technique in infertility has shown that re-implanted samples do not always function and the duration of tissue activity / viability is variable.
3. The biopsies are obtained through a surgical procedure that while safe and commonly performed can be associated with potential surgical risks and requires a general anaesthetic. In addition, the potential impact of removing ovarian tissue on long-term ovarian function including future fertility, especially in women who do not have a clear indication to do so, requires further assessment and evaluation.
There is also a need to assess the theoretical unknown risk of ovarian cancer that may be associated with re-implanting ovarian tissue and the potential risk of breast cancer with delayed menopause as well as the contraceptive requirements in women who do not desire a pregnancy.
The procedure should also be compared against the standard more controllable ways of managing the menopause that are currently used including HRT. The latter has been well studied and its safety has been demonstrated in numerous studies over many years.
This report explores a potentially promising concept for women at risk of medically or surgically induced menopause. However, when it comes to considering this in the context of delaying the menopause, further evaluation is needed to assess the safety of this technique, its effectiveness and the length of time such re-implanted tissue continues to function. Such assessment should also include a benefit / risk analysis particularly when applied in otherwise healthy women.
The British Menopause Society therefore recommends that this procedure should be initially assessed in controlled clinical research trials to evaluate its safety and feasibility before it could be considered as a potential option in clinical practice.