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, 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. Beyond our product portfolio, we offer thorough support through our dedicated clinical engineering teams specially trained in our technology.

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.2

    Disclaimer: This product is no longer for sale.

  • 1960s

    The first human chorionic gonadotropin (hCG) is added to the fertility portfolio.3

  • 1970s

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

  • 1981

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

  • 1988

    Serono 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 injection), indicated for triggering ovulation in women receiving fertility treatment, 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 for injection) prefilled injection pen is launched in the US.9

  • 2007

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

  • 2009

    EMD Serono initiates the Grant for Fertility Innovation, committing to go beyond drugs and value the importance of in vitro fertilization (IVF) labs and technologies.10

  • 2012

    Merck KGaA, Darmstadt, Germany, announces a strategic partnership with Auxogyn, providing scientific and medical support.11

  • 2013

    Gonal-f® RFF Redi-ject® (follitropin alfa injection) pen is launched in the US.12

  • 2014

    Merck KGaA, Darmstadt, Germany, forms the Fertility Technologies Unit to drive innovation for the betterment of patients.13

  • 2015

    Global collaboration agreement begins with Genea Biomedx, extending the product portfolio in fertility technologies.14

    Global Fertility Alliance is formed with Genea Biomedx and Illumina, focusing on improving fertility-related lab processes.15  

  • 2016

    The Fertility Technologies business unit is launched in the US, consisting of embryologists, engineers, and sales associates—all focused on driving innovation in the lab.

  • 2017

    Gidget™, an electronic witnessing and workflow visualization system, is launched in the US.

  • 2018

    Geri®, a benchtop incubator with independent embryo monitoring, is launched in the US.

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. Merck Serono and Auxogyn Announce Collaboration on Eeva® test [press release]. Merck Serono; October 18, 2012. http://www.marketwired.com/press-release/merck-serono-and-auxogyn-announce-collaboration-on-eeva-test-1715176.htm. Accessed June 19, 2018. 12. Food and Drug Administration. Label and Approval History GONAL-F REDI-JECT. http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021684s036lbl.pdf. Revised October 2013. Accessed June 19, 2018. 13. Merck Serono Announces Exclusive License Agreement with Auxogyn for Eeva® Test [press release]. Merck Serono; April 3, 2014. https://www.businesswire.com/news/home/20140403005073/en/Auxogyn-Announces-Exclusive-License-Agreement-Eeva-Test. Accessed June 19, 2018. 14. Merck Serono as Pioneer in Assisted Reproductive Treatments Takes Leading Role in Fertility Technologies Signing a Global Collaboration Agreement with Genea Biomedx [press release]. Merck Serono; May 28, 2015. http://news.emdgroup.com/EMD/CC/EMDNewsRelease.nsf/0/AF45A3E06E9BB1D9C1257E5200746F3A/$FILE/GeneaUS.pdf. Accessed June 19, 2018. 15. Merck, Illumina and Genea Form the Global Fertility Alliance for Excellence in Assisted Reproductive Treatment [press release]. Merck Serono; June 8, 2015. https://www.prnewswire.com/news-releases/merck-kgaa-darmstadt-germany-illumina-and-genea-form-the-global-fertility-alliance-for-excellence-in-assisted-reproductive-treatment-300095391.html. Accessed June 19, 2018.

IMPORTANT RISK INFORMATION Expand+
  • INDICATIONS AND USAGE:  

    • Induction of ovulation (OI) and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure
    • Development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle.
      - Prior to treatment, complete an evaluation of female and male partners to determine infertility diagnosis. Primary ovarian failure and potential pregnancy should be excluded. 

    CONTRAINDICATIONS: 

    • hypersensitivity to rhFSH preparations or excipients
    • high levels of FSH indicating primary gonadal failure
    • pregnancy (Pregnancy Category X)
    • uncontrolled non-gonadal endocrinopathies (thyroid, adrenal, pituitary disorders)
    • sex hormone dependent tumors of the reproductive tract and accessory organs
    • tumors of pituitary gland or hypothalamus
    • abnormal uterine bleeding, and ovarian cyst or enlargement of undetermined origin, not due to polycystic ovary syndrome.

    WARNINGS AND PRECAUTIONS:

    • For use by physicians specializing in fertility treatment or reproductive health and only when appropriate monitoring facilities are available.
    • Gonal-f® RFF Redi-ject® is a potent gonadotropin.  The lowest effective dose should be used given risk of abnormal ovarian enlargement and Ovarian Hyperstimulation Syndrome (OHSS).  Ultrasound monitoring of ovarian response and/or measurement of estradiol levels are important to minimize risks.  If symptoms of OHSS (severe pelvic or abdominal pain and distension, nausea, vomiting, diarrhea, severe ovarian enlargement, weight gain, dyspnea, oliguria) develop, all gondotropin treatment should be stopped, hCG should be withheld, and intercourse should be prohibited.  OHSS can be severe and requires hospitalization and treatment of fluid and electrolyte imbalances.  OHSS may occur with or without pregnancy.  Women should be assessed for the development of OHSS for at least two weeks after hCG administration.
    • Serious systemic hypersensitivity reactions, including anaphylaxis, have been reported in the postmarketing experience.  Symptoms have included dyspnea, facial edema, pruritis, and urticaria.  If an anaphylactic or other serious allergic reaction occurs, initiate appropriate therapy including supportive measures if cardiovascular instability and/or respiratory compromise occur, and discontinue further use. 
    • Thromboembolic events both in association with, and separate from OHSS have been reported in women treated with gonadotropins.  Women with generally recognized risk factors for thrombosis, such as personal or family history, severe obesity, or thrombophilia, may have an increased risk of venous or arterial thromboembolic events, during or following treatment with gonadotropins.  Sequelae of such reactions have included venous thrombophlebitis, pulmonary embolism, pulmonary infarction, cerebral vascular occlusion (stroke), and arterial occlusion resulting in loss of limb and rarely in myocardial infarctions.  In rare cases, pulmonary complications and/or thromboembolic reactions have resulted in death.  In women with recognized risk factors, the benefits of OI and ART need to be weighed against the risks. 
    • Serious pulmonary conditions (e.g., atelectasis, acute respiratory distress syndrome and exacerbation of asthma) have been reported in women treated with gonadotropins. 
    • Ovarian torsion has been reported after treatment with gonadotropins.  This may be related to OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, previous or current ovarian cyst and polycystic ovaries.  Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate detorsion. 
    • The couple should be advised of the potential risk of multi-fetal gestation and birth before beginning therapy.  During clinical trials, multiple births occurred in 20% of live births in women receiving therapy for ovulation induction and 35.1% of live births in women undergoing ART. 
    • The incidence of congenital malformations after some ART [specifically in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)] may be slightly higher than after spontaneous conception. This slightly higher incidence is thought to be related to differences in parental characteristics (e.g., maternal age, maternal and paternal genetic background, sperm characteristics) and to the higher incidence of multi-fetal gestations after IVF or ICSI. 
    • Since women undergoing ART often have tubal abnormalities, the incidence of ectopic pregnancy may be increased
    • The incidence of spontaneous abortion may be increased.  However, causality has not been established.  This may be a factor of the underlying infertility.
    • Both benign and malignant ovarian neoplasms have been infrequently reported; causality has not been established.
    • Both ultrasound and serum estradiol measurement should be used to monitor follicular growth and maturation, timing of the ovulatory trigger, detecting ovarian enlargement, and minimizing the risk of the OHSS and multiple gestation. 

    ADVERSE REACTIONS:

    The most common adverse reactions (≥5%) in OI include: headache, abdominal pain, and ovarian hyperstimulation.  The most common adverse reactions (≥5%) in ART include: abdominal pain, nausea, abdominal enlargement, headache, and injection site reactions (pain, bruising). 

    PATIENT COUNSELING:

    In addition to advising patients about the proper use of treatment, the duration and necessity of monitoring, handling of missed doses, OHSS, and multi-fetal gestation and birth, patients should be advised to review the Patient Information Leaflet which contains risk information, follow the Instructions for Use for the Gonal-f® RFF Redi-ject®, not share the device or reuse needles, and to ask their HCP about questions.

    Please click here for Full Prescribing Information for Gonal-F® RFF Redi-ject®.

     

    *RFF, Revised Formulation Female

  • INDICATIONS AND USAGE:

    For women, Gonal-f® (follitropin alfa for injection) and Gonal-f® RFF* (follitropin alfa injection) are indicated for 1) the induction of ovulation and pregnancy in the anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure and 2) for the development of multiple follicles in the ovulatory patient participating in an ART program. 

    Gonal-f® is also indicated for the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure.

    IMPORTANT RISK INFORMATION:

    These products should only be prescribed by physicians specializing in fertility or reproductive health.  Use of Gonal-f® or Gonal-f® RFF by women can result in multiple births.  Gonal-f® and Gonal-f® RFF  are potent gonadotropins capable of causing mild to severe adverse reactions, including Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary complications.  Gonal-f® and Gonal-f® RFF are contraindicated in women and men who exhibit prior hypersensitivity to recombinant FSH preparations or one of their excipients, high levels of FSH indicating primary gonadal failure, uncontrolled thyroid or adrenal dysfunction, sex hormone dependent tumors of the reproductive tract and accessory organs, and an organic intracranial lesion such as a pituitary tumor.  Additionally, Gonal-f® and Gonal-f® RFF  should not be given to women with abnormal bleeding,  presence or enlargement of an ovarian cyst of undetermined origin, or who are pregnant or nursing.  The most common side effects reported in women using Gonal-f® and Gonal-f® RFF include headache, abdominal pain, enlarged abdomen, ovarian cysts, nausea, and upper respiratory infections. 

    Men using Gonal-f® have commonly reported acne, breast pain and growth, fatigue.  Injection site reactions have been reported.

    Please click here for Full Prescribing Information for Gonal-f® RFF Multi-Dose.

     

    *RFF, Revised Formulation Female

  • INDICATIONS AND USAGE:

    For women, Gonal-f® (follitropin alfa for injection) and Gonal-f® RFF* (follitropin alfa injection) are indicated for 1) the induction of ovulation and pregnancy in the anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure and 2) for the development of multiple follicles in the ovulatory patient participating in an ART program. 

    Gonal-f® is also indicated for the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure.

    IMPORTANT RISK INFORMATION:  

    These products should only be prescribed by physicians specializing in fertility or reproductive health.  Use of Gonal-f® or Gonal-f® RFF by women can result in multiple births.  Gonal-f® and Gonal-f® RFF  are potent gonadotropins capable of causing mild to severe adverse reactions, including Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary complications.  Gonal-f® and Gonal-f® RFF are contraindicated in women and men who exhibit prior hypersensitivity to recombinant FSH preparations or one of their excipients, high levels of FSH indicating primary gonadal failure, uncontrolled thyroid or adrenal dysfunction, sex hormone dependent tumors of the reproductive tract and accessory organs, and an organic intracranial lesion such as a pituitary tumor.  Additionally, Gonal-f® and Gonal-f® RFF  should not be given to women with abnormal bleeding,  presence or enlargement of an ovarian cyst of undetermined origin, or who are pregnant or nursing.  The most common side effects reported in women using Gonal-f® and Gonal-f® RFF include headache, abdominal pain, enlarged abdomen, ovarian cysts, nausea, and upper respiratory infections.

    Men using Gonal-f® have commonly reported acne, breast pain and growth, fatigue.  Injection site reactions have been reported.

    Please click here for Full Prescribing information for Gonal-f® RFF 75 IU.

     

    *revised formulation female

  • INDICATION

    Indications and Usage

    Cetrotide® (cetrorelix acetate for injection) is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation. Cetrotide® should be prescribed by physicians who are experienced in fertility treatment.

    IMPORTANT RISK INFORMATION

    CONTRAINDICATIONS

    Cetrotide® is contraindicated in women who exhibit hypersensitivity to cetrorelix acetate, mannitol or medicines similar to Cetrotide®, who exhibit prior hypersensitivity to GnRH or any other GnRH analogs, or who are pregnant, are breast-feeding or have severe kidney disease.

    WARNINGS AND PRECAUTIONS

    Ovarian Hyperstimulation Syndrome (OHSS), with or without blood vessel or lung problems, can occur with the use of fertility drugs.

    ADVERSE REACTIONS

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

    Please click here for Full Prescribing information for Cetrotide®.

  • INDICATION

    Ovidrel® PreFilled Syringe (choriogonatropin alfa injection) is indicated for the induction of final falicular maturation and early lutenization in infertile women who have undergone pituitary desenitation and who have been appropriately pretreated with folicle stimulating hormones as part of an Assisted Reproductive Technology (ART) program such as in vitro fertilization (IVF) and embryo transfer. Ovidrel® PreFilled Syringe is also indicated for the induction of ovulation (OI) and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary organ failure. Ovidrel® PreFilled Syringe should only be used by physicians who are thoroughly familiar with infertility problems and their management.

    IMPORTANT RISK INFORMATION

    Ovidrel® PreFilled Syringe is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (CHSS) in women with or without blood vessel or lung problems. Ovidrel® PreFilled Syringe is contraindicated in women who exhibit prior sensitivity to hCG preparations or their ingredients, primary ovarian failure, uncontrolled thyroid or adrenal dysfunction and pregnancy. Women who are nursing should also not use Ovidrel® PreFilled Syringe. The most common side effects in women using Ovidrel® PreFilled Syringe include abdominal pain, injection site reactions, nausea and vomiting. Reports of multiple births have been associated with Ovidrel® PreFilled Syringe treatment.

    Please click here for Full Prescribing information for Ovidrel®.

    • 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)