Pregnyl (Human Chorionic Gonadotropin) - Summary

PREGNYL SUMMARY

Human chorionic gonadotropin (HCG), a polypeptide hormone produced by the human placenta, is composed of an alpha and a beta sub-unit. The alpha sub-unit is essentially identical to the alpha sub-units of the human pituitary gonadotropins, luteinizing hormone (LH) and follicle-stimulating hormone (FSH), as well as to the alpha sub-unit of human thyroid-stimulating hormone (TSH). The beta sub-units of these hormones differ in amino acid sequence. PREGNYL® (chorionic gonadotropin for injection, USP) is a highly purified pyrogen-free preparation obtained from the urine of pregnant females. It is standardized by a biological assay procedure. It is available for intramuscular injection in multiple dose vials containing 10,000 USP Units of sterile dried powder with 5 mg monobasic sodium phosphate and 4.4 mg dibasic sodium phosphate. If required, pH is adjusted with sodium hydroxide and/or phosphoric acid. Each package also contains a 10 mL vial of solvent containing: water for injection with 0.56% sodium chloride and 0.9% BENZYL ALCOHOL, WHICH IS NOT FOR USE IN NEWBORNS. If required, pH is adjusted with sodium hydroxide and/or hydrochloric acid.

PREGNYL (CHORIOGONADOTROPIN ALFA) is indicated for the following:

HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR “NORMAL” DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE-RESTRICTED DIETS.

1. Prepubertal cryptorchidism not due to anatomical obstruction. In general, HCG is thought to induce testicular descent in situations when descent would have occurred at puberty. HCG thus may help predict whether or not orchiopexy will be needed in the future. Although, in some cases, descent following HCG administration is permanent, in most cases, the response is temporary. Therapy is usually instituted in children between the ages of 4 and 9.
2. Selected cases of hypogonadotropic hypogonadism (hypogonadism secondary to a pituitary deficiency) in males.
3. Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and who has been appropriately pretreated with human menotropins.

NEWS HIGHLIGHTS

Media Articles Related to Pregnyl (Chorionic Gonadotropin)

Infertility Quiz: Test Your IQ of Infertility
Source: MedicineNet Anemia Specialty [2017.09.19]
Title: Infertility Quiz: Test Your IQ of Infertility
Category: MedicineNet Quiz
Created: 6/17/2011 2:45:00 PM
Last Editorial Review: 9/19/2017 6:39:53 PM

Consider Acupuncture for Incontinence, Not Certain Infertility Cases
Source: MedicineNet Acupuncture Specialty [2017.06.28]
Title: Consider Acupuncture for Incontinence, Not Certain Infertility Cases
Category: Health News
Created: 6/27/2017 12:00:00 AM
Last Editorial Review: 6/28/2017 12:00:00 AM

Infertility
Source: MedicineNet Antiphospholipid Syndrome Specialty [2017.05.16]
Title: Infertility
Category: Symptoms and Signs
Created: 10/13/2003 12:00:00 AM
Last Editorial Review: 5/16/2017 12:00:00 AM

Infertility: Types, Treatments, and Costs
Source: MedicineNet Endometrial Biopsy Specialty [2016.05.31]
Title: Infertility: Types, Treatments, and Costs
Category: Slideshows
Created: 12/10/2010 5:53:00 PM
Last Editorial Review: 5/31/2016 12:00:00 AM

For Unexplained Infertility, Breast Cancer Drug No Better Than Standard Treatment
Source: MedicineNet letrozole Specialty [2015.09.24]
Title: For Unexplained Infertility, Breast Cancer Drug No Better Than Standard Treatment
Category: Health News
Created: 9/23/2015 12:00:00 AM
Last Editorial Review: 9/24/2015 12:00:00 AM

more news >>

Published Studies Related to Pregnyl (Chorionic Gonadotropin)

Examining the temperature of embryo culture in in vitro fertilization: a randomized controlled trial comparing traditional core temperature (37°C) to a more physiologic, cooler temperature (36°C). [2014]
OBJECTIVE: To determine whether culture at a more physiologically cooler temperature, as suggested by limited human and animal data, would improve blastulation and pregnancy rates in human clinical IVF...

The effect of low dose human chorionic gonadotropin on follicular response and oocyte maturation in PCOS patients undergoing IVF cycles: a randomized clinical trial of efficacy and safety. [2011.12]
PURPOSE: To compare the efficacy of two regimens of low dose human chorionic gonadotropin (hCG) on follicular response and oocyte maturation in women with polycystic ovarian syndrome (PCOS)... CONCLUSIONS: A combination of FSH and low dose hCG improved oocyte maturity and preserved outcomes with improved safety and lowered cost.

Is earlier administration of human chorionic gonadotropin (hCG) associated with the probability of pregnancy in cycles stimulated with recombinant follicle-stimulating hormone and gonadotropin-releasing hormone (GnRH) antagonists? A prospective randomized trial. [2011.11]
OBJECTIVE: To evaluate the association of timing of hCG administration and probability of pregnancy in patients stimulated with recombinant FSH/GnRH antagonists for IVF...

Levels of the epidermal growth factor-like peptide amphiregulin in follicular fluid reflect the mode of triggering ovulation: a comparison between gonadotrophin-releasing hormone agonist and urinary human chorionic gonadotrophin. [2011.05]
OBJECTIVE: To detect differences in follicular fluid (FF) levels of amphiregulin (AR), depending on mode of triggering final oocyte maturation.

Follicle-stimulating hormone administered at the time of human chorionic gonadotropin trigger improves oocyte developmental competence in in vitro fertilization cycles: a randomized, double-blind, placebo-controlled trial. [2011.04]
OBJECTIVE: To determine whether an additional follicle-stimulating hormone (FSH) bolus administered at the time of the human chorionic gonadotropin (hCG) trigger can improve the developmental competence of the oocyte.

more studies >>

Clinical Trials Related to Pregnyl (Chorionic Gonadotropin)

Study of Pregnyl as Adjunct Therapy for High-Risk or Refractory Acute GVHD [Not yet recruiting]
The purpose of this study is to determine the maximum tolerated dose (MTD) of Pregnyl® when given in combination with standard immunosuppressive therapy in pediatric and adult patients with high-risk (Arm 1) or refractory (Arm 2) aGVHD.

A Randomised Trial Using Highly Purified Human Chorionic Gonadotropin (HP-hCG) and Recombinant Human Chorionic Gonadotropin (rhCG) in Women Undergoing Controlled Ovarian Stimulation [Not yet recruiting]
This trial is investigating the efficacy and safety of highly purified human chorionic gonadotropin (HP-hCG) and recombinant human chorionic gonadotropin (rhCG) for triggering of final follicular maturation in women undergoing controlled ovarian stimulation

Comparison of Micro-dose Human Chorionic Gonadotropin (hCG) With Human Menopausal Gonadotropin (HMG) in Polycystic Ovary Syndrome [Completed]
The purpose of this study is to compare the effectiveness of low dose human chorionic gonadotropin (HCG) in combination with clomiphen citrate to induce ovulation and its endocrine response in patients who had previously failed to ovulate on clomiphen citrate alone. The investigators will also compare the effectiveness and endocrine response of this approach with the regimen of adding HMG to clomiphen citrate.

Study of NTx®-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients [Terminated]
The purpose of this study is:

- To assess the neurological outcome in acute ischemic stroke patients treated with

NTx®-265, when compared with patients given a placebo control.

- To assess the safety and tolerability of NTx®-265 when given to acute ischemic stroke

patients.

A Study of Human Chorionic Gonadotrophin as Luteal Phase Support in Frozen Embryo Transfer [Recruiting]
A randomised trial on the use of luteal phase support in frozen-thawed embryo transfer cycles. The hypothesis of the study is that the use of luteal phase support with human chorionic gonadotrophin would increase the pregnancy rate in frozen-thawed embryo transfer cycles.

more trials >>

Reports of Suspected Pregnyl (Chorionic Gonadotropin) Side Effects

Ovarian Hyperstimulation Syndrome (6),  Benign Hydatidiform Mole (5),  Drug Ineffective (4),  Ovarian Torsion (4),  Maternal Exposure During Pregnancy (3),  Photosensitivity Reaction (2),  Rash Pruritic (2),  Dizziness (2),  Abortion Induced (2),  Rash Maculo-Papular (2), more >>