AMELGEN (progesterone)

Key points

Unfavourable opinion for reimbursement in luteal phase supplementation as part of an assisted reproductive technology programme in women.

Role in the care pathway?

Assisted reproductive technology (ART) is indicated when a couple is faced with medically confirmed infertility, or to prevent the transmission of a serious disease to the child or to one of the members of the couple.

In particular, luteal phase supplementation is necessary in women undergoing in vitro fertilisation (IVF).

For luteal phase supplementation, the 2013 NICE (National Institute for Health and Care Excellence) guidelines consider progesterone to be the first-line approach, before considering the other alternatives (such as human chorionic gonadotrophin, hCG), which increase the likelihood of ovarian hyperstimulation. In addition, the 2019 ESHRE (European Society of Human Reproduction and Embryology) guidelines consider progesterone to be the only treatment recommended for post-IVF luteal support.

At present, several proprietary medicinal products containing progesterone have an MA in France for luteal supplementation during in vitro fertilisation (IVF) cycles:

• UTROGESTAN and ESTIMA progesterone vaginal soft capsules, as well as their generics;
• CRINONE progesterone vaginal gel, 80 mg/g;
• PROGIRON solution for subcutaneous or intramuscular injection with 25 mg progesterone.

Role of the medicinal product in the care pathway

Given the absence of demonstration of the non-inferiority of AMELGEN (400 mg progesterone pessary) versus CRINONE (progesterone vaginal gel, 80 mg/g), and despite the potential value of this proprietary medicinal product in view of its treatment regimen, AMELGEN (progesterone) has no role in the care pathway for luteal phase supplementation as part of an assisted reproductive technology (ART) programme.