Ovaplant Salmon Gonadotropin – Releasing Hormone analogue (sGnRHa - Ovaplant)

INAD#
11-375

Ovaplant is a synthetic peptide analogue of salmon gonadotropin-releasing hormone (sGnRHa). It is presented in a biodegradable cholesterol-based matrix as an intramuscular pellet implant and is only available for purchase through Syndel USA. The use of hormones to induce spawning in fish is critical to the success of many aquatic programs that needs hormone treatment to complete final gamete maturation to ensure spawning. The primary goal of field studies conducted under INAD #11-375 is to generate data to help determine appropriate Ovaplant treatment regimens for inducing gamete maturation in a variety of cultured finfish species. The standard dose rate is between 10 – 75 microgram (µg) sGnRHa per kilogram (kg) body weight administered as a pellet implant. However, a maximum dose of 150 µg sGnRHa per kg body weight is allowed in certain situations involving very small broodfish (e.g. fish <1kg bw). Treated fish are not allowed to be released or slaughtered for human consumption (i.e., all treated broodfish must be maintained indefinitely or destroyed). To participate in the INAD Program for Ovaplant visit the data collecting site.

Please read the Study Protocol prior to any treatments. It contains the protocol, SDS, and a copy of the forms to be used as a guide for collecting data that will be entered into the AADAP INAD: Online Data Reporting. The FDA authorization letter(s) for this INAD is currently only available by emailing Bonnie Johnson.

Objective/Purpose
Collect supportive and pivotal data needed to establish the effectiveness of Ovaplant to induce gamete maturation in a variety of fish species.
Drug Name
Ovaplant; Salmon Gonadotropin - Releasing Hormone analogue (sGnRHa)

Drug Source

Syndel USA
1441 W Smith Rd
Ferndale, WA 98248
United States

Jason Montgomery
Phone
800-283-5292
Target Pathogens
Not Applicable
Method of Administration
Pellet-implant treatment
Treatment Dosage

10 - 75 microgram (μg) sGnRHa per kilogram (kg) body weight. Maximum 150 µg sGnRHa per kg body weight in certain situations involving very small broodfish (e.g. fish <1 kg bw)

Treatment Regimen
  • Single treatment
  • Pellets can’t be altered or cut prior to implanting into the fish
Investigational Withdrawal Period
  • No Release. All treated broodfish must be maintained indefinitely or destroyed.
Required Test Parameters
  • Investigator must collect data reporting percent ovulation and/or percent spermiation in treated fish. Investigator should also report general fish behavior and any adverse effects relating to treatment.
Limitations or Restrictions on Use of Drug
  • Investigator must follow all instructions in the Study Protocol for INAD 11-375 regarding drug acquisition and handling, fish treatment and disposition, and data reporting requirements.
  • Drug discharge must be in compliance with localNPDES permitting requirements.
Required Fee
$700/facility/year
AADAP Contact Information