Advancing Fertility

EMD Serono, Inc., a business of Merck KGaA, Darmstadt, Germany, is a leader in the US biopharmaceutical arena, integrating cutting-edge science and technology with patient support programs that help ensure access to our therapies. The company’s US footprint continues to grow, with more than 850 employees around the country and fully integrated commercial, clinical, and research operations in the company’s home state of Massachusetts.

With a focus on specialized therapeutic areas, including reproductive health, neurology, oncology and metabolic endocrinology, the company is committed to growing existing therapeutic areas and entering into new ones by developing both biotherapeutic proteins and small molecules.

For over 60 years, EMD Serono has grown a portfolio of fertility treatments and technology that spans the fertility cycle. Knowledgeable feedback and insights from our patients, reproductive endocrinologists, embryologists, lab directors, nurses, and other healthcare professionals have informed and shaped our products.

Pioneers in Fertility Treatment

We are proud of our strong heritage in fertility treatment. Our ongoing commitment is to provide healthcare professionals and patients with treatment options that aim to improve patient outcomes.  

  • 1906

    Professor Cesare Serono establishes the Istituto Farmacologico Serono in Rome.

  • 1947

    Piero Donini, an IFS chemist, successfully extracts and purifies the first gonadotropin preparation from the urine of postmenopausal women. This becomes the basis for Serono’s first human menopausal gonadotropin (hMG) hormone.1

  • 1950

    The first human menopausal gonadotropin preparation for clinical use, “Pergonal® 25 Serono,” is registered in Italy.1

    Disclaimer: This product is no longer for sale.

  • 1960s

    The first human chorionic gonadotropin (hCG) is added to the fertility portfolio in Italy.2

  • 1970s

    Urofollitropin, a urinary follicle-stimulating hormone (FSH) indicated for the stimulation of follicular development and the induction of ovulation, is developed in Italy.2

  • 1981

    The first US IVF baby, Elizabeth Jordan Carr, is born on December 28 through stimulation with a Serono product.4

  • 1988

    Scientists successfully express human FSH in a Chinese hamster ovarian cell line.5 This becomes the technological basis for the recombinant gonadotropin product portfolio.

  • 1995

    In a worldwide first, Gonal-f® (follitropin alfa) is approved as the first recombinant follicle-stimulating hormone.6

  • 2000

    Ovidrel® (choriogonadotropin alfa for injection) is granted approval by the US Food and Drug Administration.7

    Serono launches gonadotropin releasing hormone (GnRH) antagonist, Cetrotide® (cetrorelix acetate for injection) in the US.8

  • 2004

    Gonal-f® RFF Pen (follitropin alfa injection) prefilled injection pen is launched in the US.9

  • 2007

    Merck KGaA, Darmstadt, Germany, acquires Serono S.A.

  • 2013

    Gonal-f® RFF Redi-ject (follitropin alfa injection) pen is launched in the US.10

  • 2017

    EMD Serono launches enhanced Gonal-f® RFF* Redi-ject® (follitropin alfa injection) pen.11

REFERENCES: 1. Rosenberg E, ed. The Human Testis: Proceedings of the Workshop Conference Held at Positano, Italy, April 23-25, 1970. New York, NY: Plenum Press. Advances in Experimental Medicine and Biology; vol 10. 2. Lunenfeld, B. Historical perspectives in gonadotrophin therapy. Hum Reprod Update. 2004;10(6):453-467. 3. Serono A. A Tale of Two Hormones. The Story of FSH and LH. Geneva, Switzerland: The Ares-Serono Group; 1996. 4. Cohen J, Trounson A, Dawson K, et al. The early days of IVF outside the UK. Hum. Reprod. 2005;11(5):439-460. 5. Howles CM. Genetic engineering of human FSH (Gonal-F(R)). Hum Reprod Update. 1996;2(2):172-191. 6. First EMEA Approval Is For Serono’s Gonal-F [press release]. The Pharma Letter; October 30, 1995. https://www.thepharmaletter.com/article/first-emea-approval-is-for-serono-s-gonal-f. Accessed June 6, 2018 7. Ovitrelle 250 micrograms/0.5 ml prefilled syringe. electronic Medicines Compendium (eMC) Web site. https://www.medicines.org.uk/emc/medicine/14386. Updated December 16, 2016. Accessed June 6, 2018. 8. Serono buys exclusive rights to ‘Cetrotide’ fertility drug [press release]. ICIS News; September 5, 2000. http://www.icis.com/resources/news/2000/09/05/120076/serono-buys-exclusive-rights-to-cetrotide-fertility-drug/. Accessed June 6, 2018. 9. Food and Drug Administration. Label and Approval History GONAL-F RFF. http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21765_follitropin_lbl.pdf. Revised March 2004. Accessed June 19, 2018. 10. Merck Serono Commits € 1.2 million to the Grant for Fertility Innovation (GFI) for 2015/16. Merck Serono; June 17, 2015. http://www2.grantforfertilityinnovation.com/emdserono.country.gfi/EMDSerono/images/GFIPressRelease2015FINAL2363_25352.pdf. Accessed June 19, 2018. 11. 100% of participants rated the enhanced Redi-ject® as easy to learn how to use and easy to use (n=60). The enhanced Redi-ject® and Instructions for Use were evaluated using a 7-point Likert-type scale: a score of 5-7 indicated a positive result (easy), a score of 1-3 indicated a negative result (difficult), and a score of 4 indicated a neutral result.

IMPORTANT RISK INFORMATION Expand+
  • IMPORTANT RISK INFORMATION for Gonal-f® RFF* Redi-ject® (follitropin alfa injection):

    Gonal-f® RFF* Redi-ject® (follitropin alfa injection) is a prescription medicine containing follicle-stimulating hormone (FSH) used in infertile women to:

    • help healthy ovaries develop (mature) and release an egg
    • cause your ovaries to make multiple (more than 1) eggs as part of an Assisted Reproductive Technology (ART) program

    Do not use Gonal-f® RFF Redi-ject® if you:

    • are allergic to recombinant human FSH or any of the ingredients listed on the product carton or insert
    • are pregnant or think you may be pregnant
    • have uncontrolled thyroid or adrenal problems
    • have a tumor in your female organs, including your ovaries, breast, or uterus
    • have a tumor in your brain, such as a tumor in your pituitary or hypothalamus
    • have abnormal bleeding from your uterus or vagina
    • have ovarian cysts or large ovaries, not due to polycystic ovary syndrome (PCOS)

    Before using Gonal-f® RFF Redi-ject®, tell your healthcare provider about your medical history including any prescription or over-the-counter medicines, vitamins and herbal supplements used, whether you have or have had asthma, abdominal surgery, ovarian cysts, polycystic ovarian disease, blood clots (thrombosis) or family history of blood clots, or are breastfeeding or plan to breastfeed.

    Gonal-f® RFF Redi-ject® may cause serious side effects, including severe or fatal allergic reactions. Stop using Gonal-f® RFF Redi-ject® and go to the hospital right away if you have symptoms of an allergic reaction which can include shortness of breath, swelling of your face, itchy, red bumps or rash on your skin (hives).

    Other serious side effects include stomach bloating or pain caused by enlargement of your ovaries, or fluid build-up in your stomach, chest and heart caused by ovarian hyperstimulation syndrome (OHSS). OHSS can require hospitalization and in rare cases has caused death. Call your healthcare provider right away if you have symptoms of OHSS, including trouble breathing, severe lower stomach (pelvic) area pain, decreased urine output, nausea, vomiting, weight gain, and diarrhea. Gonal-f® RFF can also cause or worsen lung problems (including asthma), blood and blood vessel problems (including clots and stroke), or twisting of your ovary, which require medical attention.

    Use of Gonal-f® RFF Redi-ject® can result in pregnancy with more than 1 baby and the birth of multiple babies, miscarriage, or ectopic pregnancy (pregnancy outside your womb). Chances of having a baby with birth defects may increase in a baby born after an ART cycle and can be impacted by maternal age, paternal sperm problems, and genetic background associated with the egg and sperm.

    The most common side effects of Gonal-f® RFF Redi-ject® include headache, stomach pain, stomach bloating, bruising at the injection site, and nausea. Other side effects reported include sinus infections and ovarian cysts. If you have used fertility medicines like Gonal-f® RFF Redi-ject® before to get pregnant, you may have an increased chance of having tumors in your ovary(ies) (including cancer).

    These are not all the possible side effects of Gonal-f® RFF Redi-ject®. For more information, read the product labeling, and ask your healthcare provider or pharmacist.

    Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Use Gonal-f® RFF Redi-ject® as directed and do not change your dose unless directed. Do not share your Gonal-f® RFF Redi-ject® and needles with another person; you may give another person an infection or get an infection from them.

    Carefully review the Gonal-f® RFF Redi-ject® Instructions for Use that comes with the Pen for information about the correct use of Gonal-f® RFF Redi-ject® and follow all training and instruction provided by your healthcare provider.

    *RFF, Revised Formulation Female

    US-RDJ-1013-0006(2)

  • IMPORTANT RISK INFORMATION for Gonal-f® (follitropin alfa for injection):

    Gonal-f® (follitropin alfa for injection) is a prescription medicine containing follicle-stimulating hormone (FSH) used in infertile women to:

    • help healthy ovaries develop (mature) and release an egg
    • cause your ovaries to make multiple (more than 1) eggs as part of an Assisted Reproductive Technology (ART) program

    Gonal-f® can also be prescribed to increase sperm production in men with a rare medical condition.

    Do not use Gonal-f® if you:

    • are allergic to recombinant human FSH or any of the ingredients listed on the product carton or insert
    • are pregnant or think you may be pregnant
    • have uncontrolled thyroid or adrenal problems
    • have a tumor in your female organs, including your ovaries, breast, or uterus
    • have a tumor in your brain, such as a tumor in your pituitary or hypothalamus
    • have abnormal bleeding from your uterus or vagina
    • have ovarian cysts or large ovaries, not due to polycystic ovary syndrome (PCOS)
    • permanent damage to the male sex organs (testes)

    Before using Gonal-f®, tell your healthcare provider about your medical history including any prescription or overthe-counter medicines, vitamins and herbal supplements used, whether you have or have had asthma, abdominal surgery, ovarian cysts, polycystic ovarian disease, blood clots (thrombosis) or family history of blood clots, or are breastfeeding or plan to breastfeed.

    Gonal-f® may cause serious side effects, including severe or fatal allergic reactions. Stop using Gonal-f® and go to the hospital right away if you have symptoms of an allergic reaction which can include shortness of breath, swelling of your face, itchy, red bumps or rash on your skin (hives).

    Other serious side effects include stomach bloating or pain caused by enlargement of your ovaries, or fluid build-up in your stomach, chest and heart caused by ovarian hyperstimulation syndrome (OHSS). OHSS can require hospitalization and in rare cases has caused death. Call your healthcare provider right away if you have symptoms of OHSS, including trouble breathing, severe lower stomach (pelvic) area pain, decreased urine output, nausea, vomiting, weight gain, and diarrhea. Gonal-f® can also cause or worsen lung problems (including asthma), blood and blood vessel problems (including clots and stroke), or twisting of your ovary, which require medical attention.

    Use of Gonal-f® can result in pregnancy with more than 1 baby and the birth of multiple babies, miscarriage, or ectopic pregnancy (pregnancy outside your womb). Chances of having a baby with birth defects may increase in a baby born after an ART cycle and can be impacted by maternal age, paternal sperm problems, and genetic background associated with the egg and sperm.

    The most common side effects of Gonal-f® include headache, stomach pain, stomach bloating, bruising at the injection site, and nausea. Other side effects reported include sinus infections and ovarian cysts. If you have used fertility medicines like Gonal-f® before to get pregnant, you may have an increased chance of having tumors in your ovary(ies) (including cancer).

    In men, common side effects include skin pimples, breast pain and growth, and tiredness.

    These are not all the possible side effects of Gonal-f®. For more information, read the product labeling, and ask your healthcare provider or pharmacist.

    Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Use Gonal-f® as directed and do not change your dose unless directed. Do not share your Gonal-f® and needles with another person; you may give another person an infection or get an infection from them.

    Carefully review the Gonal-f® Multi-dose Patient Information Leaflet that comes with the product and follow all training and instruction provided by your healthcare provider. The injection syringes provided with the product should only be used with Gonal-f® Multi-dose and should not be used to administer any other drug or hormone.

  • IMPORTANT RISK INFORMATION for Gonal-f® RFF* (follitropin alfa for injection):

    Gonal-f® RFF* (follitropin alfa for injection) is a prescription medicine containing follicle-stimulating hormone (FSH) used in infertile women to:

    • help healthy ovaries develop (mature) and release an egg
    • cause your ovaries to make multiple (more than 1) eggs as part of an Assisted ReproductiveTechnology (ART) program

    Do not use Gonal-f® RFF if you:

    • are allergic to recombinant human FSH or any of the ingredients listed on the product carton or insert
    • are pregnant or think you may be pregnant
    • have uncontrolled thyroid or adrenal problems
    • have a tumor in your female organs, including your ovaries, breast, or uterus
    • have a tumor in your brain, such as a tumor in your pituitary or hypothalamus
    • have abnormal bleeding from your uterus or vagina
    • have ovarian cysts or large ovaries, not due to polycystic ovary syndrome (PCOS)

    Before using Gonal-f® RFF, tell your healthcare provider about your medical history including any prescription or over-the-counter medicines, vitamins and herbal supplements used, whether you have or have had asthma, abdominal surgery, ovarian cysts, polycystic ovarian disease, blood clots (thrombosis) or family history of blood clots, or are breastfeeding or plan to breastfeed.

    Gonal-f® RFF may cause serious side effects, including severe or fatal allergic reactions. Stop using Gonal-f® RFF and go to the hospital right away if you have symptoms of an allergic reaction which can include shortness of breath, swelling of your face, itchy, red bumps or rash on your skin (hives).

    Other serious side effects include stomach bloating or pain caused by enlargement of your ovaries, or fluid build-up in your stomach, chest and heart caused by ovarian hyperstimulation syndrome (OHSS). OHSS can require hospitalization and in rare cases has caused death. Call your healthcare provider right away if you have symptoms of OHSS, including trouble breathing, severe lower stomach (pelvic) area pain, decreased urine output, nausea, vomiting, weight gain, and diarrhea. Gonal-f® RFF can also cause or worsen lung problems (including asthma), blood and blood vessel problems (including clots and stroke), or twisting of your ovary, which require medical attention.

    Use of Gonal-f® RFF can result in pregnancy with more than 1 baby and the birth of multiple babies, miscarriage, or ectopic pregnancy (pregnancy outside your womb). Chances of having a baby with birth defects may increase in a baby born after an ART cycle and can be impacted by maternal age, paternal sperm problems, and genetic background associated with the egg and sperm.

    The most common side effects of Gonal-f® RFF include headache, stomach pain, stomach bloating, bruising at the injection site, and nausea. Other side effects reported include sinus infections and ovarian cysts. If you have used fertility medicines like Gonal-f® RFF before to get pregnant, you may have an increased chance of having tumors in your ovary(ies) (including cancer).

    These are not all the possible side effects of Gonal-f® RFF. For more information, read the product labeling, and ask your healthcare provider or pharmacist.

    Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Use Gonal-f® RFF as directed and do not change your dose unless directed. Do not share your Gonal-f® RFF and needles with another person; you may give another person an infection or get an infection from them.

    *RFF, Revised Formulation Female

    US-FOL-1014-0001

  • IMPORTANT INFORMATION ABOUT THE PROPER USE AND RISKS OF CETROTIDE® (cetrorelix acetate for injection):

    What are the uses of Cetrotide® (cetrorelix acetate for injection)?

    Cetrotide® blocks the effects of a natural hormone, called gonadotropin-releasing hormone (GnRH). GnRH controls the secretion of another hormone, called luteinizing hormone (LH), which induces ovulation during the menstrual cycle.

    During hormone treatment for ovarian stimulation, premature ovulation may lead to eggs that are not suitable for fertilization. Cetrotide® blocks such undesirable premature ovulation.

    Who should not use Cetrotide®?

    Cetrotide® should not be used in patients who are pregnant, think they might be pregnant, or are breastfeeding.

    Cetrotide® should not be used in patients with kidney disease.

    Patients that are allergic to cetrorelix acetate, mannitol, or exogenous peptide hormones (medicines similar to Cetrotide®) should not use Cetrotide®. Consult your doctor before taking Cetrotide® if you have had severe allergic reactions.

    What are the possible side effects of Cetrotide®?

    Your doctor should review with you the risks and benefits of using Cetrotide®. As with any medication, report any and all side effects, symptoms, or physical changes to your doctor.

    Mild and short-lasting reactions may occur at the injection site like reddening, itching, and swelling. Nausea and headache have also been reported.

    Call your doctor if you have any other side effect or if you are unsure about the effect of this medicine.

    US-CET-0614-0001

  • IMPORTANT INFORMATION ABOUT THE PROPER USE AND RISKS OF OVIDREL® PREFILLED SYRINGE (choriogonadotropin alfa injection):

    What are the uses of Ovidrel® PreFilled Syringe (choriogonadotropin alfa injection)?

    Ovidrel® PreFilled Syringe contains recombinant human choriogonadotropin alfa (hCG), an injectable hormone. This is the hormone that causes your eggs to finish maturing and be released. You may be given Ovidrel® PreFilled Syringe to complete this final stage of your cycle. Doctors specializing in infertility or reproductive health prescribe Ovidrel® PreFilled Syringe to those women trying to have a child but for a variety of reasons need medical assistance. After a thorough medical exam to determine your specific medical condition, your doctor may prescribe Ovidrel® PreFilled Syringe because you require hormone replacement or supplementation as part of your treatment program. Ovidrel® PreFilled Syringe may be one of several drugs prescribed to a patient as part of a treatment program.

    Who should not use Ovidrel® PreFilled Syringe?

    Ovidrel® PreFilled Syringe should not be used in patients who are pregnant or breastfeeding, in patients with primary ovarian failure (the ovaries no longer produce eggs), or in patients with allergies to hCG or any other ingredients in the medication.

    Patients with cancer of the sex organs or brain, or with uncontrolled thyroid or adrenal disease, should not use Ovidrel® PreFilled Syringe. Women with a history of abnormal bleeding from the uterus or vagina or with swollen, enlarged, or painful ovaries should speak to their doctor before starting treatment.

    In infertile women undergoing assisted reproductive technologies (ART) and ovulation induction (OI), Ovidrel® PreFilled Syringe should not be administered until adequate follicular development is indicated by serum estradiol and vaginal ultrasonography.

    Ovidrel® PreFilled Syringe administration should be withheld in situations where there is an excessive ovarian response, as evidenced by multiple follicular development, clinically significant ovarian enlargement or excessive estradiol production.

    What are the possible side effects of Ovidrel® PreFilled Syringe?

    Your doctor should review with you the risks and benefits of using Ovidrel® PreFilled Syringe. As with any medication, report any and all side effects, symptoms, or physical changes to your doctor.

    Ovidrel® PreFilled Syringe can cause serious side effects including ovarian hyperstimulation syndrome (OHSS) and lung and blood vessel problems. Contact your healthcare provider if you experience severe pain or bloating in the stomach or pelvic area, severe upset stomach, vomiting, or weight gain.

    Use of fertility drugs can be associated with fertilization of more than one egg. This can lead to complications for the mother and the birth of two or more babies.

    The most common side effects in women using Ovidrel® PreFilled Syringe include abdominal pain, nausea, and vomiting. Needle injections may cause some discomfort.

    US‐HCG‐0614‐0002(1)

    • Gonal-f® RFF Redi-ject® (follitropin alfa injection)

    • Gonal-f® Multi-Dose (follitropin alfa for injection)

    • Gonal-f® RFF 75 IU (follitropin alfa for injection)

    • Cetrotide (cetrorelix acetate for injection)

    • Ovidrel® PreFilled Syringe (choriogonadotropin alfa injection)