Orgalutran in the IVF protocol - instructions for use

Operating principle

Ganirelix (the active ingredient of Orgalutran), produced in the hypothalamus, affects the pituitary gland. It provokes the secretion of the gonadotropin hormones follitropin (FSH) and luteotropin (LH). As a result, the menstrual cycle is activated, the ovarian follicles develop, and a dominant follicle with a mature egg is released.

With in vitro fertilization, spontaneous ovulation must be prevented. Therefore, controlled drug stimulation of the ovaries is carried out. Ganirelix prevents the release of the gonadotropins FSH and LH to prevent premature ovulation. Inhibition of tropic hormones by Orgalutran is completely reversible.

Recommendations at the stage of superovulation stimulation

This stage takes on average 8-12 days and includes injections of drugs to stimulate follicle growth. Gonadotropin drugs are used (Menopur, Puregon, Gonal-f, Elonva, etc.), as well as drugs to suppress the pituitary gland - gonadotropin-releasing hormone agonists and antagonists (diferelin, decapeptyl, cetrotide, orhalutran).

At this stage, follicle growth is monitored and, if necessary, the dose of prescribed medications is adjusted. Next, when the follicles reach a diameter of 18-20 mm, an ovulation trigger (hCG drug or gonadotropin agonist) and a puncture date are assigned.

While stimulating follicle growth, it is recommended to lead a measured, healthy lifestyle, spend more time in the fresh air, and eliminate physical activity. It is also advisable not to be sexually active. It is important to understand that by prescribing stimulation, we achieve the growth of all existing antral follicles, so sometimes more than 10 of them can grow. The ovaries increase in volume, which can lead to a feeling of heaviness and discomfort in the lower abdomen.

During this period, a gentle fractional diet with a high protein content is recommended. It is necessary to exclude raw vegetables and fruits, spicy, salty, fried, wholemeal black bread, and legumes.

You cannot take laxatives or do a cleansing enema before a puncture without a doctor’s permission.

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Rules for the administration of Orgalutran

place and type of injection: thigh area subcutaneously. It is advisable to change the location for a new injection;
same injection time;
do not use if there are any impurities in the solution, or if the liquid has lost its transparency;
do not mix with other drugs;
Dispose of the syringe after use.

You can do the injections at home yourself after consulting a doctor and receiving detailed instructions.

Introduction rules

Mode of application

wash your hands, treat them with a disinfectant solution or wear medical gloves;
treat the injection site with alcohol and allow to dry (up to one minute);
remove the cap from the needle;
remove air from the syringe;
squeeze the skin with your fingers;
insert the needle, first check that it is in the correct position;
Slowly squeeze the solution under the skin with a piston;
remove the needle;
Press the puncture site with a swab containing alcohol.

If you miss the injection time, do not administer a double dosage. You need to give the next injection. If the missed interval is more than 6 hours, then you need to consult your doctor.

Standard treatment with Orgalutran begins 5-6 days after the use of gonadotropins and continues until ovulation is induced. Treatment can be adjusted by the gynecologist taking into account individual characteristics, the IVF protocol, and other factors. GnRH antagonists can shorten the duration of therapy and also reduce the risk of gonadal hyperstimulation.

Reception scheme

Orgalutran®

- Ganirelix should only be prescribed by a doctor experienced in treating infertility using assisted reproductive technologies.

—Women with signs or symptoms of active allergic conditions should use special caution. In reported cases, hypersensitivity reactions occurred upon administration of the first dose of the drug (see section "Side effects"). In the absence of clinical practice, treatment with Orgalutran® is not indicated for women with severe allergic conditions. The packaging material for the drug contains natural rubber latex, which can cause allergic reactions.

— Orgalutran® should be injected subcutaneously, preferably into the anterior thigh. The injection site should be changed. The patient can administer the drug independently, provided that she is properly instructed and can consult a specialist.

- Orgalutran® and FSH should be administered at approximately the same time. Drugs should not be mixed in the same syringe, and different areas of the body should be used for their administration.

— Daily use of the drug Orgalutran® should continue until a sufficient number of preovulatory follicles are formed. The final maturation of the follicles can be initiated by administering the drug human chorionic gonadotropin (hCG). Considering the half-life of ganirelix, the interval between injections of Orgalutran®, as well as the time between the last injection of Orgalutran® and the hCG injection, should not exceed 30 hours, otherwise a premature LH peak may occur. Therefore, when administering the drug Orgalutran® in the morning, its use should be continued, incl. including the day of hCG administration. When prescribing Orgalutran® in the evenings, the last injection should be made in the evening of the day preceding the day of hCG administration.

— Luteal phase support should be carried out in accordance with the methodology adopted in the infertility clinic.

— The drug should be used during repeated courses of treatment only after a thorough assessment of the degree of potential risk and the effectiveness of treatment.

— During or after ovulation stimulation, ovarian hyperstimulation syndrome (OHSS) may occur. The risk of this complication should always be taken into account when performing gonadotropin stimulation.

— Treatment of OHSS of moderate and severe severity is carried out in a hospital. Restoration and maintenance of circulating plasma volume, correction of hemostasis and water-electrolyte balance, and stimulation of diuresis are indicated.

— Preclinical data based on studies of general toxicity and genotoxicity indicate the safety of the drug in humans. The drug has no teratogenic properties.

— The safety and effectiveness of the drug have not been established for women weighing less than 50 kg or more than 90 kg.

— The incidence of congenital malformations after the use of assisted reproductive technologies (ART) may be slightly higher than in the population.

This slight increase is thought to be due to parental characteristics (eg, maternal age, sperm characteristics) and the higher incidence of multiple pregnancies after ART. There is no indication that an increased risk of congenital malformations is associated with the use of GnRH antagonists during ART. It has been shown that the incidence of congenital malformations in children (more than 1000 newborns) born after controlled ovulation stimulation therapy with Orgalutran® is comparable to the previously reported frequency after controlled ovulation stimulation therapy using GnRH agonists.

— Early ultrasound confirmation that the pregnancy is intrauterine is important. Since infertile women who undergo ART, especially in vitro fertilization (IVF), often have pathology of the fallopian tubes, therefore, the incidence of ectopic pregnancy may increase.

— In controlled studies of the drug Orgalutran® using a “long protocol” of G nRH agonists (start of the protocol from 21 to 23 days of the menstrual cycle preceding stimulation), as a comparison, therapy with the drug Orgalutran® led to more rapid growth of follicles in the first days of stimulation, but the number There were slightly fewer growing follicles at the end of stimulation and, on average, the concentration of estradiol in the blood plasma was lower. This particular pattern of follicular growth requires that FSH dose adjustments be made based on the number and size of growing follicles rather than on the amount of circulating estradiol.

— If you miss the time of administration of
the drug:
Do not administer a double dose of the drug in order to make up for the missed injection. If the patient remembers that she forgot to inject the drug, the drug should be administered as soon as possible.

If the delay in administration of the drug Orgalutran® is more than 6 hours (i.e., the interval between administrations of the drug is more than 30 hours), the patient should immediately administer the drug and consult a doctor as soon as possible.

Contraindications

Orgalutran is not used for absolute contraindications:

hypersensitivity to the active substance or auxiliary components;
allergic reactions to gonadotropin-releasing factor or any similar hormone;
severe renal and liver failure;
pregnancy, lactation;
postmenopause.

With relative restrictions, the doctor decides on the advisability of administering the drug individually.

Such contraindications include:

tendency to allergies;
intolerance to the materials from which the syringe, needle, cap are made;
increased risk of developing ovarian hyperstimulation;
congenital malformations of the female reproductive system;
moderate kidney and liver dysfunction;
possible ectopic pregnancy when using Orgalutran if there is damage to the fallopian tubes.

The effectiveness of the drug depends on body weight. It is higher in patients less than 50 kg and more than 90 kg.

Contraindications

ORGALUTRAN (solution)

fruitfulness).
And again packs of hormones. At first there were vaginal suppositories with progesterone “Endometrin” (I couldn’t say goodbye to them for almost 4 months). And with the beginning of the new cycle, I was prescribed injections in the stomach - HuMoG and Foligraf (I’ll write about them later). These drugs made it possible to create conditions (hormonal background) for superovulation. With their help, 12 full-fledged eggs appeared in my ovaries. But the question was blunt: what to do to prevent these eggs from ovulating before they are removed. At the Medivin clinic, where we did IVF, fertility specialist Irina Yuryevna Kotsyubskaya suggested using another drug that inhibits ovulation - Orgalutran. Externally, this drug looked like this: Sealed in a plastic box, a completely glass syringe with special protective rubber bands inside to prevent the drug from leaking. And the drug itself was already inside. I personally really liked this, because factory defects happen less often than human factors... The syringe cap is combined of plastic and durable, reliable rubber. Under the cap I saw a small needle soldered into the glass (like insulin syringes). The syringe itself looked like this:

Well, of course I’m attaching an image of the needle itself:

The movements of the syringe are progressive, without sudden jumps, smooth, which does not allow the valuable drug to be lost. why valuable? For one dose of the drug (this is the syringe) we paid 1400 UAH. (well, now it will probably cost even more). We used three such injections in a couple of days. By the way, they were injected in the stomach, below the navel. I would like to add that I am allergic and was very afraid of my reaction to the drugs in the IVF protocol, but everything worked out. The only thing was that the Orgalutran injections had some unpleasant consequences - bruises on the stomach, and immediately after the injection the area became slightly swollen and turned red. These injections were a little more painful than others, but the game was worth the candle))

The downside is that it is almost impossible to find this product on sale. I was lucky because the clinic provided the drug. It is not publicly available. But it is not strange, since it is the strongest hormone.

In the end, I did not ovulate prematurely and we were able to extract 9 eggs using puncture (another 3 were not amenable to the procedure, which often happens). Of the 9 cells, 8 were fertilized, and after 5 days of the incubation period, 6 embryos survived. We planted 2, one of which turned into our baby under the heart. We froze another 4 embryos. We left it for later ;)) Therefore, I want to say that the drug “Orgalutran” helped us a lot. Despite the high price, if your doctor prescribes it, be sure to use it! I recommend!

Possible side effects

local temporary reactions (12%): skin itching in the injection area, swelling, redness. Symptoms go away on their own 1-4 hours after the injection;
weakness - 0.3%;
headache - 0.4%;
nausea - 0.5%.

Other negative reactions are associated with the use of Orgalutran in combination with gonadotropins. In rare cases, abdominal bloating is observed; pelvic pain; hyperstimulation syndrome; ectopic (ectopic) pregnancy. Even less common is hypersensitivity, which causes swelling of the face, rash, and difficulty breathing.

Don't self-medicate