Ovitrelle 250 micrograms/0.5 mL pen – choriogonadotropin alfa for ovulation induction and IVF

Ovitrelle is a medicine containing the active substance choriogonadotropin alfa – a recombinant form of human chorionic gonadotropin (hCG) produced by recombinant DNA technology. It belongs to the group of sex hormones and modulators of the genital system (gonadotropins) and is registered as a solution for injection in a pre-filled pen of 250 micrograms/0.5 mL.

The medicine is used to treat female infertility together with other medicines: in assisted reproductive technology (ART) procedures such as in vitro fertilisation (IVF), and to induce ovulation in women who do not ovulate or ovulate rarely, after stimulation of follicle growth. Ovitrelle is used under the supervision of a doctor experienced in infertility treatment.

What is Ovitrelle (choriogonadotropin alfa) used for and how should it be used?

Key facts about the medicine

What is Ovitrelle used for?

According to the official package leaflet, Ovitrelle is used together with other medicines:

• to help several follicles (each containing an egg) develop and mature in women undergoing assisted reproductive technology procedures such as in vitro fertilisation (IVF) – medicines that stimulate follicle growth are given first;
• to induce ovulation (release of an egg) in women who do not produce eggs (anovulation) or produce too few (oligo-ovulation) – after other medicines have brought about follicle development and maturation.

How is it used and dosed?

• The recommended dose is one pre-filled pen (250 micrograms/0.5 mL) given as a single injection; the maximum dose is 250 micrograms.
• Women undergoing ART (e.g. IVF): the injection is given 24 to 48 hours after the last dose of follicle-stimulating hormone (FSH) or human menopausal gonadotropin (hMG), when optimal stimulation of follicle growth has been achieved.
• Anovulatory or oligo-ovulatory women: the injection is given 24 to 48 hours after optimal follicle stimulation has been achieved; intercourse is recommended on the day of the injection and the following day.
• The medicine is injected subcutaneously (under the skin). The pen is for single use; only trained patients may self-inject, following the enclosed "Instructions for use". The exact time of injection is set by the doctor.
• After use, dispose of the needle safely and discard the pen.

The dosing above is the general dosing from the leaflet and is not an individual recommendation.

Special patient groups

• Children and adolescents: the medicine is not intended for use.
• Impaired kidney or liver function: safety, efficacy and pharmacokinetics have not been established.
• Before treatment, a doctor experienced in infertility should assess the fertility of the patient and her partner.

Contraindications – when the medicine must not be used

Ovitrelle must not be used:

• in allergy to choriogonadotropin alfa or the excipients;
• in tumours of the hypothalamus or pituitary gland;
• in ovarian enlargement or cysts of unknown origin (not related to polycystic ovary syndrome);
• in vaginal (gynaecological) bleeding of unknown origin;
• in cancer of the ovary, uterus or breast;
• in active thromboembolic disorders (inflamed veins or blood clots);
• in conditions where an effective response cannot be obtained: primary ovarian failure (early menopause), post-menopause, malformations of the sexual organs or uterine fibroid tumours incompatible with pregnancy;
• during pregnancy and breastfeeding.

Precautions and warnings

• Ovarian hyperstimulation syndrome: the risk is reduced by using the recommended dose and careful cycle monitoring (blood oestradiol, ultrasound). If OHSS develops, the doctor may advise abstaining from intercourse or using barrier protection for at least four days.
• Multiple pregnancies and birth defects: the chance of a multiple pregnancy is higher; the risk depends on age and the quality and number of eggs or embryos.
• Ectopic pregnancy: possible in women with damaged fallopian tubes – the doctor should perform an early ultrasound.
• Miscarriage: more likely than with natural conception.
• Thromboembolic events: tell your doctor if you or a family member have had blood clots, a heart attack or stroke.
• Tumours of the reproductive organs: benign and malignant tumours of the ovaries and other reproductive organs have been reported in women who underwent multiple infertility treatment regimens.
• Blood or urine pregnancy tests up to ten days after the injection may be false positive.
• The medicine is essentially "sodium-free" (less than 1 mmol sodium per dose).

Interactions with other medicines, food and drink

Tell your doctor or pharmacist about all medicines you are taking, have recently taken or might take. The leaflet does not list specific interactions, but Ovitrelle is used within a protocol with other fertility medicines, whose timing is coordinated by the doctor. hCG administration affects pregnancy test results (false positives up to 10 days).

Pregnancy and breastfeeding

Ovitrelle must not be used during pregnancy or breastfeeding. The medicine is used during infertility treatment, before conception.

Driving and using machines

Ovitrelle is not expected to affect the ability to drive and use machines.

Possible side effects

• Common (up to 1 in 10): headache; abdominal pain, abdominal distension, nausea, vomiting; mild to moderate ovarian hyperstimulation syndrome; injection-site reactions (pain, redness, swelling).
• Uncommon (up to 1 in 100): abdominal discomfort, diarrhoea; severe ovarian hyperstimulation syndrome (clearly enlarged ovaries, reduced urination, weight gain, difficulty breathing, fluid in the abdomen or chest).
• Very rare (up to 1 in 10,000): mild to severe hypersensitivity reactions (rash, anaphylactic reactions, shock); thromboembolic events (blood clots), with or without OHSS.

According to the Summary of Product Characteristics, OHSS was observed in approximately 4% of patients and the severe form in less than 0.5%. Report any suspected side effect to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• Overdose: the effects are unknown, but ovarian hyperstimulation syndrome may occur – contact your doctor.
• Missed dose: consult your doctor as soon as possible, because timing is crucial for the outcome of the procedure.
• The medicine is given as a single dose according to the doctor's protocol.

Related information

• IVF preparation – what a couple can do
• Female fertility and ovulation

For additional care and support with pregnancy planning, see also the Pregnancy and Ovulation Tests – Accuracy You Can Trust category – products in this category do not replace the medicine you have been prescribed.

Composition, packaging and manufacturer

• Active substance: choriogonadotropin alfa, 250 micrograms (approximately 6,500 IU) in 0.5 mL solution, produced by recombinant DNA technology.
• Excipients: mannitol, L-methionine, disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate monohydrate, poloxamer 188, phosphoric acid 85%, sodium hydroxide, water for injections.
• Appearance: clear, colourless to slightly yellow solution.
• Pack: 3 mL cartridge (type I glass) assembled in a pre-filled pen with 0.5 mL solution; 1 pen and 2 needles per carton.
• Marketing authorisation holder: MERCK D.O.O. BEOGRAD, Omladinskih brigada 90v, Belgrade – Novi Beograd; manufacturers listed in the documentation: Merck Serono S.p.A., Italy / Merck Serono SA, Switzerland.

Storage

• Store in a refrigerator at 2 °C to 8 °C; do not freeze.
• After opening, use immediately.
• Do not use if the solution is not clear, contains particles or shows signs of deterioration.
• Keep out of the sight and reach of children; do not use after the expiry date.

Frequently asked questions

When is the Ovitrelle injection given?

Usually 24 to 48 hours after the last dose of FSH or hMG, i.e. once optimal follicle growth has been achieved. The exact time is set by the doctor based on ultrasound and test results.

Can a pregnancy test be positive after an Ovitrelle injection even if I am not pregnant?

Yes. A blood or urine test done within ten days of the injection may be falsely positive because the medicine contains hCG. Agree on the timing of testing with your doctor.

What is ovarian hyperstimulation syndrome?

It is a condition in which the ovaries overreact to treatment and large cysts develop. Signs include lower abdominal pain, bloating, nausea, vomiting, weight gain and difficulty breathing. It occurs in approximately 4% of patients, the severe form in less than 0.5%.

How should the Ovitrelle pen be stored?

In a refrigerator at 2–8 °C, without freezing. The pen is for single use and is used immediately after opening.

Sources

• ALIMS – Package leaflet Ovitrelle®, 250 micrograms/0.5 mL, solution for injection in pre-filled pen (September 2024, in Serbian)
• ALIMS – Summary of Product Characteristics Ovitrelle®, 250 micrograms/0.5 mL, pre-filled pen (in Serbian)

Date sources were checked: 24.10.2026.