Fish and Aquatic Conservation


Ovaplant® Salmon Gonadotropin – Releasing Hormone analoque (sGnRHa) INAD #11-375

An up close shot of a rainbow trout. Credit: Robert Pos/USFWS

Summary

Ovaplant® is a synthetic peptide analogue of salmon gonadotropin-releasing hormone (sGnRHa). It is presented in a bidegradable 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 an IM injection. 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, MSDS, and a copy of the forms to be used as a guide for collecting data that will be entered into the online INAD database. The FDA authorization letter(s) for this INAD is currently only available by emailing Bonnie Johnson.


INAD objective/purpose: Collect supportive and pivotal data needed to establish the effectiveness of sGnRHa/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 USA

Jason Montgomery
Phone: 800-283-5292
Fax: 360-384-0270
email: jasonm@syndel.com
Website: www.syndel.com

Target pathogen(s): Not Applicable

Method of administration: Pellet-implant treatment

Treatment dosage:

  • 10 - 75 microgram (μg) sGnRHa per kilogram (kg) body weight.

Treatment regimen:

  • Single treatment

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 local NPDES permitting requirements.

Required INAD fee: $700/facility/year

AADAP Contact Information:
Ms. Bonnie Johnson, FWS-AADAP
Phone: 406-994-9905
Fax: 406-582-0242
email: bonnie_johnson@fws.gov