Developing the Ritex Kinderwunsch lubricant took more than three years. During this time, the University Hospital Münster was commissioned by Ritex to examine various aspects of the product. The aim was to develop a vaginal lubricant to optimally supplement the natural lubrication without causing any negative effects for the sperm. In particular, care was taken not to alter important parameters of the vaginal secretion and ejaculate, such as pH, osmolality and viscosity, and also not to introduce substances with a hormone-like effect, which could restrict the fertility of the couple trying to conceive.
Extensive studies were carried out during the development of the Kinderwunsch lubricant.
Examination of general spermiogram parameters
It could be confirmed through in vitro studies that the Ritex Kinderwunsch lubricant maintained the following spermiogram parameters
optimally. The studies were carried out on sperm samples, which were selected according to a finding of normozoospermia after 2-7 days of sexual abstinence. The sperm samples were prepared with the usual procedures for the examination and mixed in groups with different lubricants and liquids. The studies were performed in duplicate on the basis of the WHO criteria.
Review of the study results
The results of the in vitro studies were verified again by a downstream modified Kremer test. In this test, the cervix and the cervical mucus contained therein were adjusted to a laboratory scale. It was observed microscopically at intervals of several minutes to hours how the sperm move through this artificial cervix without and with the Ritex Kinderwunsch lubricant. The modified Kremer test could also confirm that Ritex Kinderwunsch lubricant is very suitable for use when trying to conceive.
Exclusion of a possible hormone-like effect
Ritex Kinderwunsch lubricant does not contain any hormones. However, recent research has shown that certain substances or substance combinations (e.g. certain parabens and phthalates) can unintentionally have a hormone-like effect on sperm. In this case, the sperm may be deemed normal according to the general spermiogram parameters (vitality, motility etc.), but they may be dysfunctional in terms of chemotaxis and the acrosome reaction, with the result being that the probability of fertilisation is also negatively affected.
Ritex has therefore carried out an interlaboratory test with various lubricants in order to rule out any adverse effects caused by (quasi-) hormonal influences on the sperm. For this purpose, it was examined whether the lubricants interfered with the effect of progesterone and prostaglandins – important natural hormonal messengers in the fallopian tubes – on the sperm. The result was that the Ritex Kinderwunsch lubricant does not adversely affect the natural hormonal effect on sperm and thus can also be used in this regard without hesitation when trying to become pregnant. However, other lubricants showed some significant, negative effects on the hormonal effect on sperm.
Application test by Dermatest
As part of the dermatological and gynaecological clinical evaluation, the tolerability of Ritex Kinderwunsch lubricant was tested and the simplicity of the application and the satisfaction of the users were ascertained. In conclusion, it was found that the Ritex Kinderwunsch lubricant is very well tolerated and very suitable for vaginal application.
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