Bruno Mozzanega

In a previous article in this newspaper, I read that emergency contraceptives never inhibit or delay ovulation when they are taken in the advanced pre-ovulatory fertile days, those in which 75 per cent of conception occurs. On the contrary, they seem to impair endometrial receptivity: in particular, ellaOne impairs the development of the endometrial tissue and decreases its expression of the receptivity markers; in this way the endometrium is not suitable for embryo implantation.

We have repeated this time and time again, despite the gynaecology academic world’s and reputable scientific societies’ obstinate denial of what already appeared to be clear. Indeed, they still claim – as Prof. Serracino Inglott does in Malta – that this pharmaceutical inhibits ovulation and is therefore able to prevent conception.

A very meticulous study carried out on fertile women clearly demonstrates that ellaOne acts by preventing the implantation of the conceived child in the maternal uterus. (Lira-Albarrán S et al: "Ulipristal acetate administration at mid-cycle changes gene expression profiling of Endometrial biopsies taken during the receptive period of the human menstrual cycle." Mol Cell Endocrinol. 2017 Feb 20. [Epub ahead of print].PII: S0303-7207(17)30111-9. DOI: 10.1016/j.mce.2017.02.024). Its authors were motivated by our same considerations: 1. Women do ovulate when they take ellaOne in the most fertile days of the cycle and 2, the endometrium is severely impaired. How could an anti-ovulatory effect be claimed as the prevalent mechanism of action?

The study evaluated 12 fertile women who were given ellaOne in a single dose, as used in reality and as intended by the manufacturer. The pharmaceutical was administered in the advanced pre-ovulatory period, that is, one-two days before ovulation. The authors highlight that ellaOne was intentionally administered during the most fertile days of the menstrual cycle, those in which 75 per cent of conception occurs following unprotected sexual intercourse, according to the unanimously accepted data by Wilcox.

The women were studied in two consecutive cycles: in the first one, without administration of pharmaceuticals, the authors reported what normally happens in the endometrium due to the action of progesterone, the pro-gestational hormone that prepares the tissue to receive the embryo. In the subsequent cycle, ellaOne was administered in order to understand whether and to what extent it induces changes in the endometrial tissue. As is known, ellaOne prevents progesterone from binding to its hormonal receptors and from carrying out its pro-gestation activity.

In the first menstrual cycle, that is the normal untreated one, every woman was assessed rigorously by means of endocrine profiling and ultrasonography in order to identify the day of ovulation. Moreover, in the seventh post-ovulatory day, a time known as the "implantation window", a biopsy of the endometrium was performed to assess the expression of 1183 genes in the normal hospitable fertile endometrium. 

In the next cycle, every woman who received ellaOne in the most fertile pre-ovulatory period was controlled with the same criteria as in the previous untreated cycle. Again, in the seventh post-ovulatory day, a biopsy of the endometrium was performed to evaluate the expression of the same 1183 genes, and to assess whether the administration of ellaOne did modify their expression.

The study clearly demonstrates at least two things, as follows:

1) All the women ovulated normally after taking ellaOne in the most fertile days of the cycle. This disproves that the pharmaceutical exerts any inhibition on ovulation, although this is stated in the package leaflet of the pharmaceutical,

2) The endometrium of the women treated with ellaOne becomes absolutely inhospitable for the embryo. After ellaOne, in fact, all the studied genes were expressed in a diametrically opposite manner, when compared to their expression in a typical progestational endometrium prepared for implantation.

This means that ovulation occurs and conception can follow, since the subject matter is unprotected sex in the most fertile days. However, the conceived child cannot nest and survive. 

Such a mechanism of action just does not seem to be compatible with either Italian or Maltese laws that protect human life from its inception (e.g. the Maltese Embryo Protection Act), an inception which the European Court of Justice, too, recognizes to be coincident with fertilization (Judgment C34/10: Oliver Brüstle v Greenpeace of 18 October 2011). 

In addition, and graver still, divulging information that ellaOne interferes with ovulation, as is stated in its information leaflet, seriously and intentionally infringes the right of persons to be properly informed. Mendacious information seriously undermines freedom of choice, a freedom that can only be based on correct information in the field of procreation that has such important existential implications.

The chairperson of Maltese Medicines Authority and Maltese politicians should reflect on these data and reconsider all their positions on ellaOne.

Dr Mozzanega is Assistant Professor of Gynaecology and Teacher of “Family Planning” in the post-graduate School of Gynaecology and Obstetrics at Padua University (Italy). He is also president of the SIPRe – Società Italiana Procreazione Responsabile (www.sipre.eu)