Zivafert▼ (Human Chorionic Gonadotropin).

Adverse event reporting and prescribing information can be found at the bottom of the page.

What is Zivafert?

Zivafert is a human chorionic gonadotropin (hCG), of placental origin1. This highly purified hCG is obtained from the urine of pregnant women, collected in the Netherlands and manufactured in Switzerland, by means of an exclusive purification process developed by IBSA. Zivafert is an ambient product, designed for convenient storage and delivery at room temperature. This eliminates the need for refrigeration1.

Zivafert is administered through a subcutaneous injection.

Zivafert is indicated for:

  • Anovulatory or oligo-ovulatory women to trigger ovulation and luteinisation induction after simulation of follicle growth
  • ART program such as IVF: triggering of final follicular maturation and luteinisation after simulation of follicle growth1
The Zivafert product box

The Role of hCG

During ART, hCG has routinely been used for decades. Its similarity to luteinizing hormone (LH) allows its use to mimic the natural LH surge of the reproductive cycle2,3,4.

An illustration of a human chorionic gonadotropin molecule

Efficacy.

In 147 patients, HP-hCG (Highly Purified hCG, Zivafert (referred to as Choriomon), 10,000IU) was compared with recombinant hCG (r-hCG, Ovitrelle, 0.250mg) in a multicentre, prospective, non-inferiority, parallel group, investigator blind design, randomised controlled trial (RCT) for controlled ovarian stimulation (COS) for ART.

Results

  • In 147 patients, the number of retrieved oocytes was non-inferior when Zivafert (n=72) was used as compared to r-hCG (n=75)
  • The mean number (standard deviation) was 13.3 (6.8) in the Zivafert group and 12.5 (5.8) in the r-hCG group (p = 0.49) with a 95% Cl (-1.34, 2.77)5

Safety information.

Contraindications

  • Hypersensitivity to active substance or any of the excipients
  • Uncontrolled non-gonadal endocrinopathies (e.g., thyroid disorders)
  • Breast, uterine and ovarian tumours
  • Abnormal (not menstrual) vaginal bleeding of unknown aetiology

Zivafert PFS should not be used when an effective response cannot be obtained, such as in cases of primary ovarian failure and malformations and tumours incompatible with pregnancy.

Adverse events

  • Reactions at the site of injection which are usually mild and transient
  • The most serious adverse reaction is ovarian hyperstimulation syndrome (OHSS)
  • Local hypersensitivity reaction, abdominal pain, nausea, vomiting and diarrhoea
  • Bruising, pain, redness, swelling and itching at the injection site
  • Oedema, headache, mood changes, painful breasts, ovarian cysts

Refer to the SmPC for details on the full side effect profile, contraindications, warnings and interactions.

Additional resources.

References

  1. Zivafert Summary of Product Characteristics
  2. Venetis CA, Kolibianakis EM, Bosdou JK, et al. Estimating the net effect of progesterone elevation on the day of hCG on live birth rates after IVF: a cohort analysis of 3296 IVF cycles. Hum Reprod. 2015;30(3):684-691. doi:10.1093/humrep/deu362
  3. Rao CV. Uphill battle: the saga of hCG research that led to a paradigm shift. Indian J Med Res. 2014;140 Suppl(Suppl 1):S3-S5.
  4. Riccetti L, Klett D, Ayoub MA, et al. Heterogeneous hCG and hMG commercial preparations result in different intracellular signalling but induce a similar long-term progesterone response in vitro. Mol Hum Reprod. 2017;23(10):685-697. doi:10.1093/molehr/gax047
  5. Bellavia M, de Geyter C, Streuli I, et al. Randomized controlled trial comparing highly purified (HP-hCG) and recombinant hCG (r-hCG) for triggering ovulation in ART. Gynecol Endocrinol. 2013;29(2):93-97. doi:10.3109/09513590.2012.730577

Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk.

Adverse events should also be reported to IBSA Pharma Ltd on 01923 233466 and medicalinformation.uk@ibsagroup.com.

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get.

See Yellow Card | Making medicines and medical devices safer (mhra.gov.uk) for how to report side effects.