In short
Chorionic gonadotrophin is a protein-based hormone used in fertility treatment. It is authorised as a medicine in Italy under the brand name GONASI HP and is being studied in a Phase 3 trial involving 138 men with male infertility. The trial is testing whether chorionic gonadotrophin combined with recombinant human follicle stimulating hormone can improve sperm concentration in men with low testosterone and normal FSH levels.
Key points
- Chorionic gonadotrophin is a protein-based hormone classified as a gonadotrophin (ATC code G03GA01).
- It is authorised as a medicine in Italy under the brand name GONASI HP.
- A Phase 3 trial is testing chorionic gonadotrophin combined with r-hFSH-alfa in 138 men with male infertility.
- The trial measures sperm concentration after 16 weeks of treatment compared to no treatment.
- Chorionic gonadotrophin is given by intramuscular injection as a solution for injection.
- The trial is currently authorised but not yet recruiting.
What is chorionic gonadotrophin?
Chorionic gonadotrophin, also known as human chorionic gonadotrophin (hCG), is a protein-based hormone classified as a gonadotrophin (ATC code G03GA01). It is a naturally occurring hormone that belongs to the family of reproductive hormones. The substance is authorised as a medicine in Italy under the brand name GONASI HP 250 U.I./1 ml powder and solvent for solution for injection, with authorisation record IT 003763289 held by IBSA FARMACEUTICI ITALIA. In the United Kingdom, chorionic gonadotrophin is listed in NHS formularies as a restricted medicine for infertility treatment, available as an injection of 1500 IU, and is unlicensed in the UK with a German licensed product available. A recombinant form of the hormone, choriogonadotropin alfa, is marketed as Ovitrelle for use in women with infertility.
How does chorionic gonadotrophin work?
Chorionic gonadotrophin acts on the reproductive system by mimicking the action of luteinising hormone (LH), a hormone produced by the pituitary gland. In women, it is used to trigger ovulation and luteinisation in anovulatory or oligo-ovulatory women after stimulation of follicular growth. In men, chorionic gonadotrophin stimulates the testes to produce testosterone, which is why it is being studied in men with low testosterone levels and reduced sperm concentration. The trial listed in the registry is testing whether combining chorionic gonadotrophin with recombinant human follicle stimulating hormone (r-hFSH-alfa) can improve sperm concentration in men with oligozoospermia, low testosterone, and normal FSH serum levels.
Which conditions is chorionic gonadotrophin used or studied for?
- Female infertility: Chorionic gonadotrophin is used to trigger ovulation and luteinisation in women who have not responded to clomifene or who have proven hypopituitarism, and for superovulation treatment in assisted conception such as in vitro fertilisation.
- Male infertility: The ongoing Phase 3 trial is studying chorionic gonadotrophin combined with r-hFSH-alfa in men with oligozoospermia (reduced sperm concentration), low testosterone, and normal FSH serum levels.
How is chorionic gonadotrophin given?
Chorionic gonadotrophin is given by intramuscular injection as a solution for injection. In the trial, the product GONASI HP is administered at a dose of 500 IU by intramuscular injection, while the recombinant follicle stimulating hormone GONAL-f is given at 150 IU by subcutaneous injection. NHS formulary sources list chorionic gonadotrophin as an injection of 1500 IU for endocrinology use. The recombinant form choriogonadotropin alfa (Ovitrelle) is available as a pre-filled pen injection of 250 micrograms, equivalent to approximately 6500 IU.
What do the clinical trials show?
One clinical trial is listed in the EU Clinical Trials Information System for chorionic gonadotrophin as the test substance. The trial is a Phase 3, multicentre, randomised controlled trial titled APHRODITE Group 3, with a planned enrollment of 138 participants. The trial is currently authorised but not yet recruiting. Participants are men with male infertility characterised by oligozoospermia, low testosterone, and normal FSH serum levels. The primary endpoint is the evaluation of sperm concentration in millions per millilitre on the last day of treatment at week 16, compared to the untreated arm. The study compares the combined administration of r-hFSH-alfa originator plus chorionic gonadotrophin against no treatment.
Chorionic gonadotrophin is the test substance in this trial, meaning it is the medicine being investigated. The trial is conducted as a collaborative research initiative across multiple centres.
What side effects are known?
The supplementary sources provided for this page do not contain specific side effect information for chorionic gonadotrophin. The NHS formulary entries describe the medicine's indications and restrictions but do not list adverse effects.