Meriofert (Menotrophin).

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

What is Meriofert?

Meriofert is a highly purified human menopausal gonadotropin (HP-hMG) containing acidic follicle-stimulating hormone (FSH) and hCG mimicking luteinizing hormone (LH) activity, which are both critical for follicular development and oocyte maturation1.

Meriofert is indicated for:

  • Ovulation induction: for the induction of ovulation in amenorrhoeic or anovulatory women who have not responded to treatment with clomiphene citrate
  • Controlled ovarian hyperstimulation (COH) within a medically assisted reproduction technology (ART): induction of multiple follicular development in women undergoing assisted reproduction techniques such as in vitro fertilisation (IVF)2
The Meriofert product box
Dosage Calculator

Guidance to healthcare professionals on how to achieve the intended prescribed daily dose of Meriofert

The critical role of LH and FSH in ovarian stimulation

FSH and LH play an integral role in the neuroendocrine control of the menstrual cycle, including follicular development3. The quality of the oocyte largely determines the embryonic potential4,5.

Meriofert consists of a mix of acidic FSH isoforms, FSH being required for oocyte and embryo development6. Meriofert contains hCG, which through binding at the LH/CG (chorionic gonadotropin) receptor7, increases LH levels8.

Efficacy.

A randomised, multicentre, prospective, investigator-blinded trial in 270 IVF patients, aged 18-39, sought to compare the efficacy of two hMG preparations (Menopur®, Ferring and Meriofert®, IBSA Institut Biochimique SA) at a starting dose of 300IU using a long down-regulated hormone agonist protocol9. The primary end-point was total number of oocytes retrieved.

Results

The total number of oocytes retrieved was higher in the Meriofert® group compared to Menopur® (Intention-to-treat, 11.6 ± 6.6 and 9.7 ± 5.9, respectively, p= 0.012, Confidence Interval (CI) = 0.43 to 3.43)

Conclusion(s): This study showed that the new hMG preparation (Meriofert®) is a viable alternative for conducting ovarian stimulation in IVF cycles.

Differences between HMG and recombinant gonadotrophins may affect oocyte morphology and embryo quality.

A sensitivity analysis from a Cochrane systematic review and network meta-analysis suggested that the use of HMG may result in a higher live birth rate compared with recombinant FSH in fresh cycles in women with predicted normal response undergoing long GnRH agonist cycles10 (Risk Ratio (RR) 0.80, 95% CI 0.68 to 0.95; 7 studies; 1575 women; I2 = 1%; low-certainty evidence).

Efficacy.

Meriofert has been a part of ART regimens in clinical practice for over 5 years11.

Meriofert is effective either in dual ovarian simulation within the same cycle or in two consecutive GnRH antagonist cycles in women with poor ovarian response12.

A healthcare professional showing a woman details of her baby scan.

Quality.

Improvements in purification methods have enabled development of highly purified human gonadotrophins that are injected subcutaneously13. Meriofert is a highly purified HMG that exhibits both FSH and LH activity2; LH activity results mainly from placental hCG (from the urine of pregnant women), with a small amount from pituitary hCG and LH (both from the urine of postmenopausal women)2.

IBSA prioritises quality in its innovative formulations and administration systems, and meets the highest standards of purity, whilst preserving the structure of glycoproteins.

A female scientist looking down a microscope, surrounded by vials of blue liquid

Safety information.

Contraindications

  • Hypersensitivity to Menotrophin or to any of the excipients
  • Ovarian enlargement or cysts not related to polycystic ovarian syndrome
  • Gynaecological bleeding of unknown cause
  • Ovarian, uterine or breast carcinoma
  • Tumours of the hypothalamus or pituitary gland

Meriofert is contraindicated when an effective response cannot be achieved, for example:

  • Primary ovarian failure
  • Malformation of sexual organs incompatible with pregnancy
  • Fibroid tumours of the uterus incompatible with pregnancy

Adverse events

The most frequent adverse reactions with Meriofert were headache and abdominal distension as well as nausea, fatigue, dizziness and pain at the injection site. The most relevant occurring adverse drug reaction in clinical trials with Meriofert is (dose-related) ovarian hyperstimulation (OHSS), generally mild with small ovarian enlargement, abdominal discomfort or pain. Only one case of OHSS was serious.

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

Additional resources.

Additional studies.

References

  1. Barbieri RL, Gargiulo AR, Jaffe RB, Strauss JF, Yen SSC. Yen and Jaffe's Reproductive Endocrinology. Elsevier; 2019.
  2. Meriofert Summary of Product Characteristics
  3. Williams CJ, Erickson GF. Morphology and Physiology of the Ovary. In: Endotext. MDText.com, Inc., South Dartmouth (MA); 2000. PMID: 25905186.
  4. Lemseffer Y, Terret ME, Campillo C, Labrune E. Methods for Assessing Oocyte Quality: A Review of Literature. Biomedicines. 2022;10(9):2184. doi:https://doi.org/10.3390/biomedicines10092184
  5. Öztürk R, Murt A. Epidemiology of urological infections: a global burden. World Journal of Urology. 2020;38(11). doi:https://doi.org/10.1007/s00345-019-03071-4
  6. Cerpa-Poljak A, Bishop LA, Hort YJ, et al. Isoelectric charge of recombinant human follicle-stimulating hormone isoforms determines receptor affinity and in vitro bioactivity. Endocrinology. 1993;132(1):351-356. doi:https://doi.org/10.1210/endo.132.1.8419133
  7. Cole, L.A. Biological functions of hCG and hCG-related molecules. Reprod Biol Endocrinol 8, 102 (2010). https://doi.org/10.1186/1477-7827-8-102
  8. Fournier T. Human chorionic gonadotropin: Different glycoforms and biological activity depending on its source of production. Ann Endocrinol (Paris). 2016;77(2):75-81. doi:10.1016/j.ando.2016.04.012
  9. Lockwood G, Cometti B, Bogstad J, et al. A randomized controlled trial comparing the efficacy and safety of two HMG preparations gaining their LH bioactivity from different HCG sources. Reprod Biomed Online. 2017;35(1):17-27. doi:10.1016/j.rbmo.2017.03.021
  10. Melo P, Thornton T, Coomarasamy A, Granne I. Evidence for the effectiveness of immunologic therapies in women with subfertility and/or undergoing assisted reproduction. Fertil Steril. 2022;117(6):1144-1159. doi:10.1016/j.fertnstert.2022.04.015
  11. Languille S, Massin N, Santulli P, et al. Real-world effectiveness of Fertistartkit® treatment in women undergoing ART in French clinical practice: a retrospective multicentre study. Reproductive BioMedicine Online. 2020;40(4):525-529. doi:https://doi.org/10.1016/j.rbmo.2020.01.002
  12. Massin N, Chevalier N, E Descat, et al. O-068 The BISTIM study: first RCT comparing dual ovarian stimulation on the same cycle (duostim) vs 2 conventional ovarian stimulations in poor ovarian responders undergoing IVF. Human Reproduction. 2022;37(Supplement_1). doi:https://doi.org/10.1093/humrep/deac104.082
  13. Leão R de BF, Esteves SC. Gonadotropin therapy in assisted reproduction: an evolutionary perspective from biologics to biotech. Clinics. 2014;69(4):279-293. doi:https://doi.org/10.6061/clinics/2014(04)10

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.