Overview

Ready-to-inject treatment.

Ovidrel® PreFilled Syringe is indicated for the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle-stimulating hormones as part of an Assisted Reproductive Technology (ART) program such as in vitro fertilization and embryo transfer.

Ovidrel® PreFilled Syringe is also indicated for Ovulation Induction (OI) and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure.

Features

Single-dose syringe.

Ovidrel® comes in a single-dose prefilled syringe, enabling accurate dosing of hCG for triggering final follicular maturation and luteinization. The pen is simple for patients to learn how to use and requires minimal training.

Ovidrel (choriogonadotropin alfa injection) pen
  • 1
    Ready to inject
  • 2
    Prefilled syringe available in 250 mcg/0.5ml

Results

The human chorionic gonadotropin demonstrated to support oocyte release in Ovulation Induction (0I) and Assisted Reproductive Technology (ART).

Ovidrel® OI Clinical Study

Ovidrel® ART Study Outcomes

In a randomized, multicenter, double-blinded study across 19 centers in Australia, Canada, Europe, and Israel in infertile women undergoing in vitro fertilization and embryo transfer, the safety and efficacy of Ovidrel® 250 μg was compared to 5,000 IU of an approved urinary-derived hCG product. The primary efficacy parameter in this single-cycle study was the patient ovulation rate. 242 patients entered the study; 99 received Ovidrel® 250 μg. The efficacy of Ovidrel® 250 μg was found to be clinically and statistically equivalent to that of the approved urinary-derived hCG product. The efficacy outcomes of Ovidrel® 250 μg were:

Ovidrel®: Clinincally proven results:

  • Ovulation rate of 91.9%
  • Clinical pregnancy rate* of 22%

 

*Clinical pregnancy was defined as a pregnancy during which a fetal sac (with or without heartbeat activity) was detected by ultrasound on day 35-42 after hCG administration.

Body System (Preferred Term) Ovidrel® 250 (N=99) Incidence Rate % (n)
At Least One Adverse Event 26.2% (26)
Application Site Disorders 16.2% (16)
Injection Site Pain 8.1% (8)
Injection Site Inflammation 2.0% (2)
Injection Site Bruising 3.0% (3)
Injection Site Reaction 3.0% (3)
Reproductive Disorders, Female 7.1% (7)
Ovarian cyst 3.0% (3)
Ovarian hyperstimulation 3.0% (3)
Gastrointestinal System Disorders 4.0% (4)
Abdominal Pain 3.0% (3)

The safety and efficacy of Ovidrel® 250 μg and Ovidrel® 500 μg were assessed in a randomized, open-label, multicenter study across 20 US centers in infertile women undergoing in vitro fertilization and embryo transfer. The primary efficacy parameter in this single-cycle study was the number of oocytes retrieved.

The efficacy of Ovidrel® 250 μg and Ovidrel® 500 μg were both found to be clinically and statistically equivalent to that of the approved urinary-derived hCG product and to each other.

The efficacy results for the patients who received Ovidrel® 250 μg were:

Study Outcome Value (n=94)
Mean number of oocytes retrieved per patient 13.60
Mean number of mature oocytes retrieved per patient 7.6
Mean number of 2 PN fertilized oocytes per patient 7.2
Mean number of 2 PN or cleaved embryos per patient 7.6
Implantation rate per embryo transferred (%) 18.7%
Mean mid-luteal serum progesterone levels (nmo/L)* 423
Clinical pregnancy rate per initiated treatment cycle (%) 35.1%
Clinical pregnancy rate per transfer (%) 36.3%

*nmo/L ÷ 3.18 = ng/mL.

†Clinical pregnancy was defined as a pregnancy during which a fetal sac (with or without heartbeat activity) was detected by ultrasound on day 35-42 after hCG administration.

For the 33 patients who achieved a clinical pregnancy with Ovidrel® 250 μg, the outcomes of the pregnancies were:

  • 4 (12.1%) clinical pregnancies did not reach term
  • 29 (87.9%) live births
  • 20 (69.0%) singletons
  • 9 (31%) multiple births
Body System (Preferred Term) Ovidrel® 250 μg (N=236) Incidence Rate % (n)
At Least One Adverse Event 33.1% (78)
Application Site Disorders 14.0% (33)
Injection Site Pain 7.6% (18)
Injection Site Bruising 4.7% (11)
Gastrointestinal Studies Disorders 8.5% (20)
Abdominal Pain 4.2% (10)
Nausea 3.4% (8)
Vomiting 2.5% (6)
Secondary Terms (Post-Operative Pain) 4.7% (11)
Post-Operative Pain 4.7% (11)

In a second, randomized, multicenter, double-blinded study, across 9 centers in Europe and Israel, in infertile women undergoing in vitro fertilization and embryo transfer, the safety and efficacy of Ovidrel® 250 μg was compared to 5,000 IU of an approved urinary-derived hCG product administered subcutaneously.

The primary efficacy parameter in this single-cycle study was the number of oocytes retrieved per patient. 205 patients entered the study, of whom 97 received Ovidrel® 250 μg.

The results for patients who received Ovidrel® 250 μg were:

Study Outcome Value (n)
Mean number of oocytes retrieved per patient 10.6
Mean number of mature oocytes retrieved per patient 10.1
Mean number of 2 PN fertilized oocytes per patient 5.7
Mean number of 2 PN or cleaved embryos per patient 5.1
Implantation rate per embryo transferred (%) 17.4%
Mean mid-luteal serum progesterone levels (nmo/L)* 394
Clinical pregnancy rate per initiated treatment cycle (%) 33%
Clinical pregnancy rate per transfer (%) 37.6%

*nmo/L ÷ 3.18 = ng/mL.

†Clinical pregnancy was defined as a pregnancy during which a fetal sac (with or without heartbeat activity) was detected by ultrasound on day 35-42 after hCG administration.

‡35-42 after hCG administration.

 

For the 32 patients who achieved a clinical pregnancy with Ovidrel® 250 μg, the outcomes were:

  • 6 (18.8%) clinical pregnancies did not reach term
  • 26 (81.2%) live births
  • 18 (69.2%) singletons
  • 8 (30.8%) multiple births
Body System (Preferred Term) Ovidrel® 250 μg (n=236) Incidence Rate % (n)
At Least One Adverse Event 33.1% (78)
Application Site Disorders 14.0% (33)
Injection Site Pain 7.6% (18)
Injection Site Bruising 4.7% (11)
Gastro-Intestinal Studies Disorders 8.5% (20)
Abdominal Pain 4.2% (10)
Nausea 3.4% (8)
Vomiting 2.5% (6)
Secondary Terms (Post-Operative Pain) 4.7% (11)
Post-Operative Pain 4.7% (11)

In a randomized, multicenter, double-blinded study across 19 centers in Australia, Canada, Europe, and Israel in infertile women undergoing in vitro fertilization and embryo transfer, the safety and efficacy of Ovidrel® 250 μg was compared to 5,000 IU of an approved urinary-derived hCG product. The primary efficacy parameter in this single-cycle study was the patient ovulation rate. 242 patients entered the study; 99 received Ovidrel® 250 μg. The efficacy of Ovidrel® 250 μg was found to be clinically and statistically equivalent to that of the approved urinary-derived hCG product. The efficacy outcomes of Ovidrel® 250 μg were:

Ovidrel®: Clinincally proven results:

  • Ovulation rate of 91.9%
  • Clinical pregnancy rate* of 22%

 

*Clinical pregnancy was defined as a pregnancy during which a fetal sac (with or without heartbeat activity) was detected by ultrasound on day 35-42 after hCG administration.

Body System (Preferred Term) Ovidrel® 250 (N=99) Incidence Rate % (n)
At Least One Adverse Event 26.2% (26)
Application Site Disorders 16.2% (16)
Injection Site Pain 8.1% (8)
Injection Site Inflammation 2.0% (2)
Injection Site Bruising 3.0% (3)
Injection Site Reaction 3.0% (3)
Reproductive Disorders, Female 7.1% (7)
Ovarian cyst 3.0% (3)
Ovarian hyperstimulation 3.0% (3)
Gastrointestinal System Disorders 4.0% (4)
Abdominal Pain 3.0% (3)

The safety and efficacy of Ovidrel® 250 μg and Ovidrel® 500 μg were assessed in a randomized, open-label, multicenter study across 20 US centers in infertile women undergoing in vitro fertilization and embryo transfer. The primary efficacy parameter in this single-cycle study was the number of oocytes retrieved.

The efficacy of Ovidrel® 250 μg and Ovidrel® 500 μg were both found to be clinically and statistically equivalent to that of the approved urinary-derived hCG product and to each other.

The efficacy results for the patients who received Ovidrel® 250 μg were:

Study Outcome Value (n=94)
Mean number of oocytes retrieved per patient 13.60
Mean number of mature oocytes retrieved per patient 7.6
Mean number of 2 PN fertilized oocytes per patient 7.2
Mean number of 2 PN or cleaved embryos per patient 7.6
Implantation rate per embryo transferred (%) 18.7%
Mean mid-luteal serum progesterone levels (nmo/L)* 423
Clinical pregnancy rate per initiated treatment cycle (%) 35.1%
Clinical pregnancy rate per transfer (%) 36.3%

* nmo/L ÷ 3.18 = ng/mL.

† Clinical pregnancy was defined as a pregnancy during which a fetal sac (with or without heartbeat activity) was detected by ultrasound on day 35-42 after hCG administration.

For the 33 patients who achieved a clinical pregnancy with Ovidrel® 250 μg, the outcomes of the pregnancies were:

  • 4 (12.1%) clinical pregnancies did not reach term
  • 29 (87.9%) live births
  • 20 (69.0%) singletons
  • 9 (31%) multiple births
Body System (Preferred Term) Ovidrel® 250 μg (N=236) Incidence Rate % (n)
At Least One Adverse Event 33.1% (78)
Application Site Disorders 14.0% (33)
Injection Site Pain 7.6% (18)
Injection Site Bruising 4.7% (11)
Gastrointestinal Studies Disorders 8.5% (20)
Abdominal Pain 4.2% (10)
Nausea 3.4% (8)
Vomiting 2.5% (6)
Secondary Terms (Post-Operative Pain) 4.7% (11)
Post-Operative Pain 4.7% (11)

In a second, randomized, multicenter, double-blinded study, across 9 centers in Europe and Israel, in infertile women undergoing in vitro fertilization and embryo transfer, the safety and efficacy of Ovidrel® 250 μg was compared to 5,000 IU of an approved urinary-derived hCG product administered subcutaneously.

The primary efficacy parameter in this single-cycle study was the number of oocytes retrieved per patient. 205 patients entered the study, of whom 97 received Ovidrel® 250 μg.

The results for patients who received Ovidrel® 250 μg were:

Study Outcome Value (n)
Mean number of oocytes retrieved per patient 10.6
Mean number of mature oocytes retrieved per patient 10.1
Mean number of 2 PN fertilized oocytes per patient 5.7
Mean number of 2 PN or cleaved embryos per patient 5.1
Implantation rate per embryo transferred (%) 17.4%
Mean mid-luteal serum progesterone levels (nmo/L)* 394
Clinical pregnancy rate per initiated treatment cycle (%) 33%
Clinical pregnancy rate per transfer (%) 37.6%

*nmo/L ÷ 3.18 = ng/mL.

† Clinical pregnancy was defined as a pregnancy during which a fetal sac (with or without heartbeat activity) was detected by ultrasound on day 35-42 after hCG administration.

‡ 35-42 after hCG administration.

 

For the 32 patients who achieved a clinical pregnancy with Ovidrel® 250 μg, the outcomes were:

  • 6 (18.8%) clinical pregnancies did not reach term
  • 26 (81.2%) live births
  • 18 (69.2%) singletons
  • 8 (30.8%) multiple births
Body System (Preferred Term) Ovidrel® 250 μg (n=236) Incidence Rate % (n)
At Least One Adverse Event 33.1% (78)
Application Site Disorders 14.0% (33)
Injection Site Pain 7.6% (18)
Injection Site Bruising 4.7% (11)
Gastro-Intestinal Studies Disorders 8.5% (20)
Abdominal Pain 4.2% (10)
Nausea 3.4% (8)
Vomiting 2.5% (6)
Secondary Terms (Post-Operative Pain) 4.7% (11)
Post-Operative Pain 4.7% (11)

Patient Resources

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Instructions for Use:

 

Prescribing Information:

 

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IMPORTANT SAFETY INFORMATION Expand+
  • 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®.