Pergoveris

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Pergoveris

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Pergoveris

Quick Facts

Property Description
Active Ingredients Lutropin Alfa and Urofollitropin
Form Solution or Lyophilized Powder for Injection
Pharmacological Class Gonadotropin Preparation
General Purpose To promote follicular development (fertility medicine)
Origin Recombinant Human Hormones

What Type of Medicine is Pergoveris?

Pergoveris is a specialized, prescription-only fertility medicine classified as a gonadotropin preparation, designed to provide the necessary hormonal support for ovarian function. It is a combination product, delivering two distinct signals—Luteinising Hormone (LH) and Follicle-Stimulating Hormone (FSH) activity—in a fixed ratio. The formulation is designed to replace or supplement gonadotropins naturally secreted by the pituitary gland. This dual-hormone structure is intended to provide a balanced stimulus throughout the ovarian cycle.

Composition and Origin: Lutropin Alfa and Urofollitropin

The product's efficacy is based on the active ingredients Lutropin Alfa and Urofollitropin (Follitropin Alfa). Lutropin Alfa provides LH activity, and Urofollitropin provides FSH activity. These hormones are synthesized using recombinant DNA technology, ensuring they are structurally identical to the endogenous human gonadotropins. This manufacturing precision yields a highly purified and consistently reliable product. The fixed ratio of these two components is a key differentiating feature, contrasting with separate monotherapy injections and is formulated for comprehensive reproductive signaling.

General Purpose and Pharmaceutical Form

The core therapeutic purpose of the medication is to promote controlled and sustained follicular development. This is typically relevant in a use scenario where a woman's body does not produce adequate levels of both LH and FSH. The medicine is supplied as a lyophilized powder and solvent for solution for injection or as a pre-mixed solution, intended for subcutaneous or intramuscular injection. This non-oral, injectable route is necessary because the active, protein-based hormones would be destroyed in the digestive tract. The stability and precise delivery achieved through injection ensure the hormones reach the ovaries effectively, supporting the overall goal of the fertility treatment process.

Regulatory References

  1. European Medicines Agency (EMA) EPAR

What side effects are possible with Pergoveris?

The official safety documentation for Pergoveris (Lutropin Alfa and Urofollitropin) organizes possible effects based on regulatory frequency classifications and system-organ classes, with specific focus on risks inherent to controlled ovarian stimulation.

Frequency-Classified Adverse Reactions

The most frequently documented reactions are classified as Very Common (affecting more than 1 in 10 individuals), and include Ovarian Cysts, Headache, and Injection Site Reactions (such as pain, swelling, or irritation). Reactions classified as Common (ge 1/100 to < 1/10) typically involve the gastrointestinal system (e.g., nausea, abdominal pain) and local pain (pelvic and breast pain).

Classification Examples of Documented Reactions
Very Common Ovarian Cysts, Headache, Injection Site Reactions
Common Mild or Moderate Ovarian Hyperstimulation Syndrome (OHSS), Abdominal Pain, Nausea, Pelvic Pain

Serious Adverse Reactions and Safety Constraints

The most significant safety focus in regulatory labeling is the risk of Ovarian Hyperstimulation Syndrome (OHSS), which can be Severe (classified as Uncommon) and may progress rapidly. Serious but Very Rare safety events documented in the context of use include Thromboembolism (involving blood clots in the lungs or circulation) and Anaphylactic Reactions. The label notes that the rate of Multiple Pregnancy/Births and Pregnancy Loss is increased in fertility treatments.

Use of the medication is subject to high-level Safety Constraints (contraindications). These include the presence of tumours of the hypothalamus or pituitary gland, existing carcinoma of the ovary, uterus, or breast, and certain gynaecological haemorrhages of unknown origin. Furthermore, safety and efficacy are not established in individuals with Renal or Hepatic Impairment.

Overdose and Emergency Response

The officially documented risk associated with overexposure to Pergoveris (Lutropin Alfa and Urofollitropin) is the potential development of Ovarian Hyperstimulation Syndrome (OHSS), a condition resulting from an excessive ovarian response as classified in regulatory guidance.

Documented Manifestations and Severe Outcomes

OHSS is documented to progress from symptoms of abdominal discomfort and distension to severe manifestations. Severe OHSS is noted in regulatory documents to include marked ovarian enlargement, severe pelvic pain, and systemic complications such as dyspnea, oliguria, and significant electrolyte imbalances. Severe cases are also associated with life-threatening outcomes, including thromboembolic events and acute pulmonary distress. The official overdose profile focuses on the adult female population for which the drug is indicated.

Actions Mandated by Regulatory Authorities

Regulatory labeling mandates specific actions when an over-response is detected. Treatment with the gonadotropin must be stopped, and the subsequent administration of human Chorionic Gonadotropin (hCG) must be withheld. If an overdose is suspected, or if early signs of OHSS—such as severe abdominal pain or unexpected rapid weight gain—are observed, individuals must seek immediate medical attention. Severe OHSS requires hospitalization for symptomatic and supportive management, including the close monitoring of fluid balance and electrolytes, as no specific antidote is known.

Therapeutic Uses of Pergoveris

Addressing Systemic Imbalance Symptoms and Episodic Conditions

This medication is commonly used in situations involving certain distressing symptoms linked to conditions marked by increased physiological stress, and the medicine is applied in settings where supportive symptom management is appropriate for condition categories presenting with recurrent or episodic manifestations, including those involving systemic or localized discomfort.

It helps address symptom clusters that may become intense or disruptive, and is often used during phases of increased distress or discomfort. The treatment is relevant for easing symptoms associated with systemic imbalance where short-term symptomatic assistance is needed. The therapy provides support that helps ease the overall symptom burden.

Quick Fact: Supports Management of Symptoms that Interfere with Daily Functioning The medication helps maintain a sense of stability when symptoms are more noticeable, supporting the patient during difficult episodes by easing distress.

Regulatory References

  1. European Medicines Agency

Eligibility and Restrictions for Use

Pergoveris is indicated exclusively for adult women with severe deficiency of both Luteinising Hormone (LH) and Follicle-Stimulating Hormone (FSH), a condition often categorized as hypogonadotropic hypogonadism. The regulatory label defines specific patient populations who must not use the medicine.

Contraindications and Prohibited Use

Pergoveris is strictly contraindicated if a patient has:

  • Hypersensitivity to the active ingredients or excipients.
  • Tumors of the hypothalamus or pituitary gland.
  • Ovarian, uterine, or mammary carcinoma (cancer).
  • Ovarian enlargement or cysts of unknown origin (unrelated to polycystic ovarian disease).
  • Unexplained gynecological haemorrhages.
  • Current pregnancy or lactation.

Use is also prohibited when conditions exist that make a successful pregnancy impossible, such as primary ovarian failure, malformations of the sexual organs, or severe uterine fibroid tumors.

Use Not Established and Restrictions

Safety and efficacy have not been established in the paediatric or elderly populations, or in patients with renal or hepatic impairment. Patients with existing thyroid, adrenal, or prolactin disorders must have these conditions addressed before starting therapy. Individuals with risk factors for thromboembolic events or a history of porphyria require close monitoring.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory documentation for Pergoveris (Lutropin Alfa and Urofollitropin) establishes a distinct interaction profile based on its structure as an injectable recombinant protein hormone. Interactions primarily relate to pharmacodynamics within the context of fertility treatment, while metabolic and pharmacokinetic interactions are not typically expected or documented.


Documented Interaction Patterns

Interaction Type Official Regulatory Statement
Pharmacodynamic Reinforcement Co-administration with, or sequential use of, other agents for ovarian stimulation, notably Human Chorionic Gonadotropin (hCG), results in an additive effect leading to an increased overall ovarian response.
Metabolic/Pharmacokinetic No formal interactions are documented involving the hepatic CYP450 enzyme system. The protein-based active ingredients are metabolized via general catabolic pathways, meaning the product is not expected to alter the exposure of other small-molecule medicines.
Food, Alcohol, and Supplements No specific restrictions or documented interaction patterns are noted for co-administration with food, alcohol, or herbal products.

Official Regulatory Constraints

There are no mandatory timing-separation rules documented in the prescribing information for Pergoveris and other medicines. Furthermore, the regulatory labels do not list any specific drug-drug combinations that are formally classified as contraindicated due to an interaction risk. The documented interaction with other ovarian stimulants is an expected functional outcome of the fertility treatment protocol.

Mechanism of Action

How Pergoveris Works

Pergoveris contains recombinant human follitropin-alfa ( r-hFSH) and lutropin-alfa ( r-hLH), which function as agonists for their respective receptors in the gonads.

The r-hFSH component binds to the FSH receptor ( FSHR) on ovarian granulosa cells. This interaction initiates an intracellular signaling cascade, primarily through the adenylyl cyclase / cAMP pathway. The subsequent increase in cAMP modulates gene transcription, leading to granulosa cell proliferation and the upregulation of the aromatase enzyme. This enzyme facilitates the conversion of androgens into estrogens.

The r-hLH component binds to the LH receptor ( LHR), which is expressed on theca cells and later on mature granulosa cells. LHR activation uses a G-protein-mediated pathway, driving the synthesis of androgens in the theca cells. The coordinated action of r-hFSH and r-hLH therefore modulates the entire physiological steroidogenic pathway required for complete follicular development.

Dosage and Administration Information

Pergoveris is administered as a daily injection under the skin (subcutaneously). This medication is available as either a powder and solvent for solution for injection or as a solution in a pre-filled pen. The first injection must be performed under the direct supervision of a healthcare professional experienced in fertility treatment, though subsequent daily injections may be self-administered after proper training.

Dosage and Administration

  • Recommended Starting Dose: Treatment typically begins with 150 IU of follitropin alfa and 75 IU of lutropin alfa once daily.
  • Dose Adjustment: The treatment regimen is tailored to the individual patient's response, which is monitored using ultrasound scans to measure follicle size and by measuring blood estrogen levels. If necessary, the follitropin alfa dose may be increased, usually in 37.5 to 75 IU increments, preferably after 7 to 14 day intervals, often using a separate follitropin alfa preparation.
  • Duration: Daily injections continue until a suitable follicle has developed, which may take up to five weeks.
  • Injection Site: The injection is typically given in the lower abdominal area or the front of the thigh. To minimize potential skin irritation, the injection site should be changed each day.

Important Considerations

  • Timing: The daily injection should be given at approximately the same time each day.
  • Missed Dose: If a dose is missed, do not take a double dose; immediately contact your doctor or nurse for guidance.
  • Storage: Before opening, Pergoveris must be stored in the original packaging in a refrigerator (2 C to 8 C) and protected from light. After the first use of the pre-filled pen, it may be stored at or below 25 C for a maximum of 28 days.

Recent Clinical Evidence

Pergoveris: Recent Clinical Evidence

Pergoveris is a combination medication containing recombinant human Follitropin alfa and recombinant human Lutropin alfa (r-hFSH and r-hLH). Research and clinical trials have focused on assessing its use in women undergoing controlled ovarian stimulation (COS) as part of Assisted Reproductive Technologies (ART), particularly those with severe LH and FSH deficiency.


Key Clinical Trial Results

Studies have investigated the efficacy profile of Pergoveris in women with hypogonadotropic hypogonadism (HH) and in normogonadotropic women undergoing COS. Key research objectives centered on assessing ovarian response, oocyte yield, and pregnancy rates.

Study Findings:

  • Ovarian Response: Clinical trials explored the effect of the combined preparation versus separate administration of the two components. Findings demonstrated that the combination was associated with successful follicular development and a consistent number of retrieved oocytes in the studied populations.
  • Live Birth Rates (LBR): Specific randomized controlled trials (RCTs) examined LBR as a primary or secondary endpoint. The data provided information on the comparative LBR between regimens that included r-hLH (as found in Pergoveris) and those that did not. Overall, the evidence supports the use of the combination therapy in the designated patient groups, specifically those requiring both FSH and LH activity.

Tolerability Profile

Analysis of pooled clinical data provided information on the tolerability profile. The most frequently observed adverse events during these studies were consistent with those expected during ovarian stimulation, primarily mild-to-moderate injection site reactions and ovarian hyperstimulation syndrome (OHSS), which was monitored according to established criteria in the trials. The concurrent use of r-hFSH and r-hLH was generally observed to be manageable within the trial settings.

Key Studies & References

  1. PERgoveriS In Stratified Treatment for Assisted Reproductive Technique (PERSIST) - ClinicalTrials.gov (NCT01297465)
  2. Recombinant human luteinizing hormone increases endometrial thickness in women undergoing assisted fertility treatments: a systematic review and meta-analysis

Frequently Asked Questions (FAQ)

Common questions about Pergoveris (FAQ)

Q: Why is Pergoveris prescribed for women with severe LH and FSH deficiency?

Official documents state that Pergoveris is indicated for the stimulation of follicular development in adult women who have a severe deficiency of both Luteinising Hormone (LH) and Follicle-Stimulating Hormone (FSH). This patient population requires both hormones for successful ovarian function, and the medication is used to provide this essential hormonal support.


Q: Are there any early signs of OHSS a patient should be aware of while taking Pergoveris?

The official product information explains that symptoms of mild to moderate Ovarian Hyperstimulation Syndrome (OHSS) may include mild-to-moderate abdominal pain, abdominal bloating, nausea, or vomiting. If a patient experiences these symptoms, they are generally directed to contact their healthcare team immediately.


Q: Is there information available on the long-term safety profile of Pergoveris?

Regulatory reviews assess the safety profile based on clinical trials and ongoing post-marketing surveillance to monitor for any new safety signals. A definitive, long-term safety statement beyond the follow-up period of clinical trials is not typically documented in official labeling.


Q: Is Pergoveris use contraindicated if a person has certain hormone-dependent tumors?

Yes, the medication is contraindicated (should not be used) if a patient has sex hormone-dependent tumors of the reproductive tract, accessory organs, or tumors of the pituitary gland or hypothalamus. These specific conditions prevent the safe use of the medicine.


Q: Can Pergoveris be used by people with a family history of porphyria?

Regulatory guidance states that patients with porphyria or a family history of porphyria should be closely monitored during treatment. Official documentation notes that if the condition deteriorates, cessation of treatment may be required by the prescribing professional.


Q: What kind of results can a patient generally expect in terms of egg retrieval numbers with Pergoveris?

Clinical trial data indicates that the use of Pergoveris is associated with successful follicular development and a consistent number of retrieved oocytes in the patient populations studied. The specific outcome observed will be based on an individual patient’s response during their monitored cycle.


Q: Is the fixed-dose ratio of FSH and LH in Pergoveris suitable for all women with severe deficiency?

Pergoveris is formulated to provide a fixed ratio of FSH and LH, designed for initial treatment. However, official information notes that the treatment regimen is tailored to the individual patient’s response, which may involve adjusting and increasing the FSH dose using a separate preparation.


Q: What are the potential signs of an allergic reaction to Pergoveris?

Allergic reactions to the medicine are considered very rare. The potential signs of an allergic reaction described in patient information can include skin reactions such as rash, red skin, or hives, or more serious signs like swelling of the face or difficulty breathing.


Q: What are the two active ingredients in Pergoveris and what do they mimic?

The two active ingredients are follitropin alfa and lutropin alfa. These ingredients are recombinant copies of the body’s natural hormones, Follicle-Stimulating Hormone (FSH) and Luteinising Hormone (LH), which are naturally secreted by the pituitary gland.


Q: Why is Pergoveris not recommended during pregnancy or breastfeeding?

The medicine is strictly contraindicated for use during pregnancy or breastfeeding. Official information notes that the frequency of pregnancy loss is higher in patients undergoing ovarian stimulation treatments, and an effect of the medicine on birth defects has not been excluded.


Q: Is Pergoveris only available in a pre-filled pen format?

Official product documentation confirms that Pergoveris is available in two formats. It is supplied as a solution for injection in a pre-filled pen and also as a powder and solvent that must be mixed to create the solution for injection.


Q: Is there an interaction risk with common non-prescription medicines or supplements while using Pergoveris?

Regulatory information does not specifically list documented interaction patterns for co-administration with common non-prescription medicines or supplements. The active ingredients are protein-based and are not expected to interact with other small-molecule medicines through the major metabolic pathways.


Q: Does the use of Pergoveris affect a patient's ability to drive or operate machinery?

Official patient information states that the medicine is not expected to affect the ability to drive or use heavy machinery. However, as with many medicines, patients typically exercise caution until they know how the medication affects them.


Q: Is there an age limit or defined age range for women who are prescribed Pergoveris?

The medication is indicated for use in adult women. Regulatory documents state that safety and efficacy have not been established in either the paediatric (children) or the elderly patient populations.


Q: Can Pergoveris be used concurrently with other fertility treatments?

The official prescribing information notes that co-administration or sequential use with other agents for ovarian stimulation, particularly Human Chorionic Gonadotropin (hCG), results in an expected additive effect. Pergoveris is used as a component within a larger assisted reproductive technology (ART) protocol.


Q: What is the official position on using Pergoveris if a patient has uncontrolled thyroid or adrenal problems?

Official documentation indicates that existing thyroid, adrenal, or prolactin disorders need to be appropriately addressed and managed prior to beginning therapy.


Q: What is the reason for using a barrier method of contraception if OHSS is developing during treatment?

In the event Ovarian Hyperstimulation Syndrome (OHSS) is developing, official protocols may include refraining from sexual intercourse or using a barrier contraceptive method. This measure is described in labeling as a protocol to prevent pregnancy in a cycle classified as high-risk for severe OHSS.

How should Pergoveris be stored and disposed of?

Storage and Disposal Requirements

Storage State Required Conditions
Unopened Pen Store in a refrigerator (2 C to 8 C). Do not freeze.
In-Use Pen Store below 25 C for a maximum of 28 days. Keep the cap on.
Unopened Powder Store below 25 C. Do not freeze.
Reconstituted Powder Use immediately and for single use only.

All forms must be stored in the original package to protect from light and kept out of the sight and reach of children. The solution must not be used if it is not clear or contains particles.

Disposal of unused product, expired medicine, and waste material must be done according to local requirements. Used needles and syringes must be placed immediately into a designated sharps disposal container and should not be discarded with household waste or down the toilet.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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