Manuel Fernández-Sánchez1, Hana Visnova2, Albert Yuzpe3, Bjarke Mirner Klein4, Bernadette Mannaerts5, Joan-Carles Arce6. 1. IVI-RMA Seville, Avda. República Argentina 58, Seville, ES-41011, Spain; Departamento de Cirugía, Universidad de Sevilla, Avda. Sánchez Pizjuan S/N, Seville, ES-41009, Spain; Departamento de Biología Molecular e Ingeniería Bioquímica, Universidad Pablo de Olavide, Seville ES-41013, Spain. Electronic address: manuel.fernandez@ivirma.com. 2. IVF CUBE SE, Prague 160 00, Czech Republic. 3. Olive Fertility Centre, Vancouver V5Z 3X7, Canada. 4. Global Biometrics, Ferring Pharmaceuticals, Copenhagen 2300, Denmark. 5. Science and Medicine, Ferring Pharmaceuticals, Copenhagen 2300, Denmark. 6. Ferring Pharmaceuticals, US Development, Parsippany, NJ 07054, USA.
Abstract
RESEARCH QUESTION: Is individualization of dosing with follitropin delta in sequential ovarian stimulation cycles an effective preventive strategy for ovarian hyperstimulation syndrome risk? If so, for which patients does an individualized strategy provide the greatest OHSS risk reduction and/or the need for additional preventive interventions? DESIGN: A secondary analysis of three ovarian stimulation cycles in IVF/intracytoplasmic sperm injection patients included in one randomized, assessor-blinded trial comparing two recombinant FSH preparations (ESTHER-1, NCT01956110), and a second trial in women undergoing up to two additional cycles (ESTHER-2, NCT01956123). Of 1326 women (aged 18-40 years) randomized and treated with follitropin delta or alfa in cycle 1, 513 continued to cycle 2 and 188 to cycle 3. Follitropin delta and alfa doses were maintained/adjusted according to ovarian response in the previous cycle. RESULTS: Individualized dosing with follitropin delta significantly reduced moderate/severe OHSS and/or preventive interventions (P=0.018) versus conventional dosing with follitropin alfa in patients undergoing up to three ovarian stimulation cycles. The greatest benefit was observed in patients in the highest anti-Müllerian hormone (AMH) quartile (P=0.012). On evaluating separately, individualized dosing with follitropin delta significantly lowered the incidences of moderate/severe OHSS (P=0.036) and preventive interventions (P=0.044) versus follitropin alfa. CONCLUSION: An individualized follitropin delta dosing regimen decreased the risk of moderate/severe OHSS as well as the incidence of preventive interventions versus a conventional follitropin alfa regimen. An analysis per AMH quartile indicated that these statistically significant differences are driven mainly by patients with the highest pretreatment AMH levels.
RCT Entities:
RESEARCH QUESTION: Is individualization of dosing with follitropin delta in sequential ovarian stimulation cycles an effective preventive strategy for ovarian hyperstimulation syndrome risk? If so, for which patients does an individualized strategy provide the greatest OHSS risk reduction and/or the need for additional preventive interventions? DESIGN: A secondary analysis of three ovarian stimulation cycles in IVF/intracytoplasmic sperm injection patients included in one randomized, assessor-blinded trial comparing two recombinant FSH preparations (ESTHER-1, NCT01956110), and a second trial in women undergoing up to two additional cycles (ESTHER-2, NCT01956123). Of 1326 women (aged 18-40 years) randomized and treated with follitropin delta or alfa in cycle 1, 513 continued to cycle 2 and 188 to cycle 3. Follitropin delta and alfa doses were maintained/adjusted according to ovarian response in the previous cycle. RESULTS: Individualized dosing with follitropin delta significantly reduced moderate/severe OHSS and/or preventive interventions (P=0.018) versus conventional dosing with follitropin alfa in patients undergoing up to three ovarian stimulation cycles. The greatest benefit was observed in patients in the highest anti-Müllerian hormone (AMH) quartile (P=0.012). On evaluating separately, individualized dosing with follitropin delta significantly lowered the incidences of moderate/severe OHSS (P=0.036) and preventive interventions (P=0.044) versus follitropin alfa. CONCLUSION: An individualized follitropin delta dosing regimen decreased the risk of moderate/severe OHSS as well as the incidence of preventive interventions versus a conventional follitropin alfa regimen. An analysis per AMH quartile indicated that these statistically significant differences are driven mainly by patients with the highest pretreatment AMH levels.
Authors: Olga Haakman; Tina Liang; Kristen Murray; Angelos Vilos; George Vilos; Carlee Bates; Andrew J Watson; Michael R Miller; Basim Abu-Rafea Journal: F S Rep Date: 2020-12-14
Authors: Veljko Vlaisavljevic; Susanna Apter; Antonio Capalbo; Arianna D'Angelo; Luca Gianaroli; Georg Griesinger; Efstratios M Kolibianakis; George Lainas; Tonko Mardesic; Tatjana Motrenko; Sari Pelkonen; Daniela Romualdi; Nathalie Vermeulen; Kelly Tilleman Journal: Hum Reprod Open Date: 2021-07-03