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Endocrine Disorders, Contraception, and Hormone Therapy during Pregnancy
Published in “Bert” Bertis Britt Little, Drugs and Pregnancy, 2022
Pergonal is an extract of urine from postmenopausal women; it contains follicle-stimulating hormone (FSH) and luteinizing hormone (LH). It is administered by intramuscular injection and is used to stimulate multiple ovarian follicular development in ovulation induction cycles. Metrodin is a purified extract of urine from postmenopausal women and primarily contains FSH. It is similar to Pergonal in its administration protocols. The frequency of birth defects was not increased among 176 and 168 infants born following exposure to follitropin compounds, alpha and beta, respectively, in the Swedish Birth Defects Registry (Kallen, 2019). Among 54 infants exposed to urofollitropin, the frequency of congenital anomalies was not increased (Kallen, 2019). In total, 398 infants were born after FSH treatments, and the frequency of malformations was not increased (Kallen, 2019).
Drugs used for ovarian stimulation Clomiphene citrate, aromatase inhibitors, metformin, gonadotropins, gonadotropinreleasing hormone analogs, and recombinant gonadotropins
Published in David K. Gardner, Ariel Weissman, Colin M. Howles, Zeev Shoham, Textbook of Assisted Reproductive Techniques, 2017
Into the reproductive therapeutic arena, another biosimilar follitropin-α (Ovaleap, TEVA, The Netherlands) has recently become commercially available. Doses of the product are delivered using a multidose pen device similar to that used for follitropin-β (Puregon).
Women's health—hormone replacement treatment
Published in H. Gavras, The Year in Hypertension 2004, 2004
VERONICA FRANCO, SUZANNE OPARIL
BACKGROUND. Follicle-stimulating hormone (follitropin) receptor knockout (FORKO) female mice exhibit reduced oestrogen production and share many characteristics, for example osteoporosis, hypercholesterolaemia and weight gain, with post-menopausal women. This study found that BP was increased in FORKO mice compared to wild type controls, while angiotensin II induced vasoconstriction was blunted and angiotensin II levels and AT receptor content (assessed by inmunoblotting) were decreased in FORKO mice. Vasodilator responses to acetylcholine (endothelium dependent vasodilation) and sodium nitroprusside (endothelium independent vasodilation) did not differ between strains. Media-to-lumen ratio of mesenteric arteries was significantly increased in FORKO mice, indicating vascular remodelling. Indices of oxidative stress were not significantly different from wild type mice.
The interchangeability of two assays for the measurement of anti-Müllerian hormone when personalizing the dose of FSH in in-vitro fertilization cycles
Published in Gynecological Endocrinology, 2021
Antonio La Marca, Aarti Deenadayal Tolani, Martina Capuzzo
Elecsys and Access assays were also compared using the Ferring dosing algorithm for Follitropin Delta. The difference between Follitropin Delta starting dose was below 5% in 60 patients (53% of patients), between 5 and 10% in 21 patients (18.5%), between 10 and 15% in 11 patients (10%); in 21 patients (18.5%) the difference exceeded 15%. In women with high ovarian reserve (AMH > 2.5 ng/ml) (n = 51), Follitropin Delta starting dose was decreased by a mean of 5.6% (± 6.1%) when using Access assay instead of Elecsys, moving from a mean of 6.3 mcg (± 1.1 mcg) to 6.0 mcg (± 0.9 mcg). In this group, only 4 out of 51 patients (7.8%) would have received a dose of Follitropin Delta that exceeded 15% difference if using the Access instead of the Elecsys assay. Interestingly, if we use the conversion factor from Access to Elecsys mentioned above (Elecsys = −0.06 + 0.88 × Access), the difference in the dose of Follitropin Delta when using the two different assays in these 4 patients would be well below 10%.
A cost-effectiveness modeling evaluation comparing a biosimilar follitropin alfa preparation with its reference product for live birth outcome in Germany, Italy and Spain
Published in Journal of Medical Economics, 2018
Salvatore Gizzo, Marcos Ferrando, Monica Lispi, Claudio Ripellino, Nazarena Cataldo, Klaus Bühler
Clinical and on-going pregnancy rates were also reported for the two preparations (clinical pregnancy rates: biosimilar follitropin alfa 28.1% [43/153] and reference follitropin alfa 35.6% [52/146]; on-going pregnancy rates per patient: biosimilar follitropin alfa 27.5% [42/153] and reference follitropin alfa 33.6% [49/146]). A total of 89.1% (41/46) of patients in the biosimilar follitropin alfa group and 88.7% (47/53) in the reference follitropin alfa group went on to have a live birth9. Based on a comparability study of biosimilar follitropin alfa versus reference follitropin alfa for the stimulation of follicular development, similar numbers of oocytes were retrieved from patients on either treatment (difference in oocytes retrieved 0.03 [95% confidence interval -0.76 to 0.82])9 and similar pregnancy rates per embryo transfer were also reported in the first and second cycles (biosimilar follitropin alfa 40.2% and 38.5%, respectively; reference follitropin alfa 48.2% and 27.8%, respectively)9. However, differences in the cost to achieve live birth between the two treatments have not been investigated.
US human factors engineering evaluation of an updated follitropin alfa pen injector (GONAL-f® RFF Redi-ject®) and instructions for use
Published in Expert Opinion on Drug Delivery, 2018
Mary Mahony, Andrea Dwyer, Raschelle Barkume, Allison Strochlic, Fabien Jeannerot, Thomas Stüdeli
Infertility is a multifactorial condition with manifold causes. Injection of exogenous gonadotropins, including follicle-stimulating hormone (FSH), is indicated for the induction of ovulation and pregnancy in the oligo-anovulatory infertile patient, in whom the cause of infertility is functional and not due to primary ovarian failure, and for the development of multiple follicles in the ovulatory patient participating in an assisted reproductive technologies (ART) treatment. Women undergoing ovulation induction (OI) or ART requiring ovarian stimulation require multiple injections of FSH over several days, usually with the dose of FSH modified throughout the treatment cycle to optimize outcomes according to each patient’s individual response to therapy [1–3]. Women undergoing treatment typically administer injections at home; however, a patient’s partner, lay caregiver, or healthcare professional (HCP) (including their fertility nurse) might also administer injections [4]. Prefilled pen injectors are approved for administration of follitropin alfa in some countries. These are designed to make injection more accurate [5–13], more discrete [7], and easier to administer [7,11,12] compared with the use of a syringe and drug vial.