Ovitrelle Helps Pregnancy-Infertility Treatment

Ovitrelle is a medicine from Merck Serono. It is used in the treatment of infertility. Women who are undergoing in vitro fertilization (IFV) can use this.


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Infertility is the most worrying thing for couples. All global surveys reveal the fact that around 50 million couples are unable to have a child. Some couples are having a problem in getting their first baby; some other couples are facing problems when they are proceeding for another baby after the birth of their first kid.

There are multiple reasons for this infertility. Ovulation disorder is one of the reasons for infertility in women. Ovulation disorder affects the release of eggs from the ovaries. MERCK introduced Ovitrelle which can help in the treatment of infertility.

First of all, you need to know about the pregnancy process for a better understanding of the role of Ovitrelle as a medicine.


What Is The Process Of Pregnancy?

The pregnancy process starts with the release of an egg (ovum) into the ovaries. For our understanding purpose, I am dividing the whole process into three steps.


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Step-1

A functional anatomical structure called a follicle (antral), develops in the ovaries. The immature egg lies in the inner wall of the follicle. Many follicles would come up with immature eggs, but only the dominant follicle, which has the average diameter of 22-24 mm, can mature and release the egg which is ready for fertilization. The other follicles will die eventually and removed by a biological process. This process of release of an egg (ovum) into ovaries is called Ovulation.

Here "ovarian reserve" plays a major role. Ovarian reserve is expressed in the number of follicles per ovary observe. This count can be used as a fertility test. If the count is between 6 and 10, the ovarian reserve is normal or adequate. If the count is below 6, the ovarian reserve is low.

There are two medical conditions which leads to infertility. They are:

Anovulation: The ovulation (release of an egg) does not take place in the women who are facing this condition. It means the immature egg (oocyte) does not form in the ovaries. This is a common cause of infertility.

Oligo-ovulation: The women who are facing this problem can have infrequent or irregular ovulation. It means the eggs are rarely produced.


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Step-2

The matured egg then travels into the Fallopian tube. It waits there for a sperm for 24 hours to fertilize it. When a sperm enters into the Fallopian tube, it reaches the matured egg and penetrates into it. Then a Zygote or fertilized egg forms. This process is called fertilization.

After the fertilization, the follicle, which released the egg, breaks down into pieces and from these pieces develop "corpus luteum". This is a hormone with a yellow colour.

The corpus luteum produces and discharges estrogens and progesterone hormones. These two hormones make the uterus (womb) ready for the implantation of a fertilized egg.


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Step-3

The zygote (fertilized egg) would stay there in the Fallopian tube for 3 to 4 days. Then slowly it moves to the uterus (womb) and attaches there. This process is called implantation.

The division process of the Zygote into multiple cells starts within 24 hours of fertilization and the process continues even in its journey through the Fallopian tube to the uterus.

hCG (human chorionic gonadotropin), a pregnancy hormone, will be released as soon as the implantation is completed. It helps in the nourishment of a fertilized egg. Then begins the development of the embryo. This is the key process of pregnancy.



Infertility treatment

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Infertility may occur due to the failure in the pregnancy process at any phase from Step-1 to Step-3. To overcome the failures, certain diagnostic methods were discovered. We will have a look into some which are relevant to our present topic.

Superovulation

Superovulation is also known as controlled ovarian stimulation. This process is used in the women who releases an egg (ovum) but not conceives. In such cases, a woman can be induced to release more than one egg by using fertility drugs to increase the probability of conceiving.

In Vitro Fertilization (IVF)

In this method, fertilization process occurs outside the woman's body artificially. In this process, the collected egg and sperm will be fused artificially in a liquid in a laboratory. Then the zygote forms and embryo development starts. Then the embryo is transferred into the uterus (womb). From there the natural cycle continues. Superovulation is part of In vitro fertilization.



What is Ovitrelle?

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Ovitrelle is a product from Merck Serono, which is used in the treatment of infertility. Dosage form: Ovitrelle 250 micrograms/0.5 ml. Description of the product is a clear colourless solution.

Choriogonadotropin alfa is the active substance in the Ovitrelle. Choriogonadotropin alfa is a therapeutic protein prepared by recombinant DNA technology and a version of hCG (human chorionic gonadotropin).

This is intended for subcutaneous administration, i.e. a small rounded mass of a substance is introduced into the bottom layer of the skin via injection. The absolute bioavailability of Choriogonadotropin alfa is about 40%.

    Suggested Reading (click on the topic):     Therapeutic Peptides and Proteins At A Glance

Ovitrelle is available in two dosage forms:

1. Reconstituted solution, i.e., powder to be mixed with the supplied solvent to make a solution for injection This solution contains 285 µg of choriogonadotropin alfa per ml.

2. The solution in a prefilled syringe or prefilled pen.

This product obtained market authorization from the European Commission on 2 Feb 2001. This approval is valid throughout the European Union.

The shelf-life of this product is 18 months. You have to use it immediately after opening. Store the product in its original package in the refrigerator at 2°C - 8°C. This is for single use only.

This product will be available only on a doctor's prescription. The doctor should have adequate experience in the treatment of fertility problems.



What Does Ovitrelle Do?

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Gonadotropic cells produce Luteinizing hormone (LH) in the pituitary gland. It has the ability to trigger ovulation and develop corpus luteum.

Choriogonadotropin alfa, the active substance in the Ovitrelle, has a similarity to Luteinizing hormone (LH). It can induce ovulation and helps to maintain pregnancy.

We have already discussed about the follicles. The growth rate of the follicles is a key factor in the whole pregnancy process. When the growth rate of follicles reaches a sufficient level, Ovitrelle is administered to trigger the ovulation.

In brief, Ovitrelle is used after the application of medicines for the stimulation of follicular growth. Then it triggers final follicular maturation.

It means it paves the way for the release of the matured egg and accelerates the process of development of the corpus luteum.

Who can use Ovitrelle?
The women who are undergoing "in vitro fertilization (IVF)" and who are facing the medical conditions of anovulation and oligo-ovulation, can use Ovitrelle under the supervision of a doctor who is a specialist in solving fertility problems.



Clinical Data Of Ovitrelle

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A study was conducted on 1140 women who were undergoing fertility treatment. The effectiveness of Ovitrelle was compared with natural hCG hormone.

The measurement criteria taken for the effectiveness of Ovitrelle was the number of eggs that were released after the treatment. Ovulation was observed in 92% of the women.

No intrinsic toxicity of choriogonadotropin alfa was observed during the preclinical safety study.

The Carcinogenic potentiality of Ovitrelle is not available since the study was not conducted.

Anyhow, the negative outcome was observed in the genotoxicity testing. Moreover, this is a protein prepared by recombinant DNA technology.



Possible Side Effects Of Ovitrelle

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During the clinical studies, some side effects were observed in patients (between 1 and 10 patients in 100). Common side effects are:

1. Reactions at the injection site
2. A headache
3. Tiredness
4. Vomiting
5. Nausea (feeling sick)
6. Abdominal pain (stomach ache)
7. Ovarian hyperstimulation syndrome



Summary

Ovitrelle is a product from Merck Serono with the dosage form of 250 micrograms/0.5 ml solution. This product is used in the treatment of infertility.

Choriogonadotropin alfa is the active ingredient in it which is prepared by recombinant DNA technology.

This product is to be used only on a doctor's prescription.

Ovitrelle is available in both powder and solution forms. This product triggers final follicular maturation and helps to maintain pregnancy.

Ovitrelle is giving a hope to couples who wish to conceive a child in their lifetime



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Author Profile

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Ram Kumar Reddy

Ram Kumar Reddy is the founder of Pharma Times Now. Helping students of Pharmacy and Chemistry and employees in the pharma industry in learning pharmaceutical science. Ram Kumar Reddy has 24 years rich experience in the Pharmaceutical industry and well versed in quality systems. He worked with Dr.Reddys and Sai Life Sciences. He lives in Hyderabad, India.



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