Gonadotropins are peptide hormones that regulate ovarian function and are essential for normal growth, sexual development and reproduction. The human gonadotropins include follicle stimulating hormone (FSH) and luteinizing hormone (LH) which are made in the pituitary, and chorionic gonadotropin (hCG) which is made by the placenta.
All three gonadotropins are heterodimeric proteins that consist of two peptide chains, the alpha chain is similar in all three, whereas the beta chain is unique and determines the fine receptor specificity and function of each hormone.
HMG – Human Menopausal Gonadotropin combination of FSH and LH in a 1 : 1 ratio that is extracted from urine obtained from postmenopausal women, widely used for Controlled Ovarian stimulation to stimulate the recruitment and development of multiple eggs during an ovulation induction cycle in women undergoing Assisted Reproductive Technology (ART) like IUI, IVF and ICSI.
FSH – Follicle Stimulating Hormone used for Controlled Ovarian stimulation to stimulate the recruitment and development of multiple eggs during an ovulation induction cycle in women undergoing Assisted Reproductive Technology (ART) like IUI, IVF and ICSI. FSH may be used alone or in combination with human menopausal gonadotropin (hMG) to induce superovulation.
HCG – Human Chorionic Gonadotropin is a pregnancy supporting hormone extracted from the urine of pregnant women and is widely used as an Ovulation Trigger that helps with the final maturation of the eggs and triggers the ovaries to release the mature eggs (ovulation) in women undergoing Assisted Reproductive Technology (ART) like IUI, IVF and ICSI. It also stimulates the corpus luteum to secrete progesterone to prepare the lining of the uterus for implantation of the fertilized egg.
Gonadotropins produced at Sanzyme are well studied with documented Characterization studies, Pre-clinical & Clinical Studies
- Gonadotropins produced at Sanzyme are well characterized with bioanalytical techniques and exhibit structural equivalence with Innovator products.
- Primary structure is established by intact mass and peptide mapping. The secondary and tertiary structure is probed by circular dichroism measurements.
- Purity size and aggregate profile is established by SE-HPLC and SDS-PAGE. Charge based isoform profiling is characterized by cIEF.
- Subunit analysis and product related impurities are established by reverse phase HPLC and reducing SDS-PAGE.
- Overall the structure, size, intact mass, purity and post translational modifications of Sanzyme Gonadotropins were similar when compared to Innovator products.
PRE CLINICAL STUDIES
- Our Gonadotropins namely HMG, FSH and HCG have been evaluated pre-clinically for toxicity viz Single dose Toxicity and Repeat Dose Toxicity studies using rodent species.
- Pre-clinical Toxicity studies were conducted according to the OECD Principles of the Good Laboratory Practice (GLP).
- The Pre-Clinical study results reaffirm the safe tolerable dose in rodents and paved the way for use in humans and support human clinical trials.
- Our Gonadotropins namely HMG, FSH and HCG have been evaluated clinically in comparison with innovator products.
- Clinical studies were conducted in accordance with the ICH-GCP (Good Clinical Practice) Guidelines and were initiated after obtaining the necessary Regulatory and Ethics Committee approvals.
- Clinical Studies are performed in collaboration with an International CRO and are in line with the global standards of regulatory requirement.
- The studies are registered prospectively with the CTRI and the results are promising in terms of “Number of Oocytes retrieved” in women undergoing In Vitro Fertilization and were proven to be Non-Inferior as compared to the Innovator products.
- Can be used safely in women undergoing ART to achieve the desired efficacy in terms of successful pregnancy.