Efficacy and safety of follitropin delta for ovarian stimulation in vitro fertilization/ intracytoplasmic sperm injection cycles: a systematic review with meta-analysis
Abstract Background Follitropin delta is a novel recombinant follicle stimulating hormone preparation uniquely expressed in a human fetal retinal cell line by recombinant DNA technology. To date, no systematic review was available about the safety and the efficacy of the follitropin delta. The objec...
| Main Authors: | , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2024-03-01
|
| Series: | Journal of Ovarian Research |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13048-024-01372-w |
| _version_ | 1797259059363053568 |
|---|---|
| author | Stefano Palomba Donatella Caserta Paolo Emanuele Levi-Setti Andrea Busnelli |
| author_facet | Stefano Palomba Donatella Caserta Paolo Emanuele Levi-Setti Andrea Busnelli |
| author_sort | Stefano Palomba |
| collection | DOAJ |
| description | Abstract Background Follitropin delta is a novel recombinant follicle stimulating hormone preparation uniquely expressed in a human fetal retinal cell line by recombinant DNA technology. To date, no systematic review was available about the safety and the efficacy of the follitropin delta. The objective of this study was systematically reviewing the available literature and to provide updated evidence regarding the efficacy-safety profile of follitropin delta when compared to other gonadotropin formulations for ovarian stimulation in in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) cycles. Methods An extensive search was performed to identify phase 1, phase 2 and phase 3 RCTs in humans focused on follitropin delta use for ovarian stimulation in IVF/ICSI cycles. The risk of bias and the overall quality of the evidence was analyzed. All data were extracted and analyzed using the intention-to-treat principle and expressed per woman randomized. Results A total of 7 RCTs (1 phase 1 RCT, 2 phase 2 RCTs and 4 phase 3 RCTs) were included in the qualitative analysis, whereas data of three phase 3 RCTs were meta-analyzed. All trials compared personalized recombinant follitropin delta treatment versus conventional recombinant follitropin alfa/beta administration in potentially normo-responder patients who receive ovarian stimulation in GnRH antagonist IVF/ICSI cycles. No difference between two regimens was detected for clinical pregnancy rate [odds ratio (OR) 1.06; 95% confidence intervals (CI): 0.90, 1.24; P = 0.49; I2 = 26%], ongoing pregnancy rate (OR 1.15; 95%CI: 0.90, 1.46; P = 0.27; I2 = 40%), and live birth rate (OR 1.18; 95%CI: 0.89, 1.55; P = 0.25; I2 = 55%). No data were available regarding cumulative success rates. The rate of adoption of strategies to prevent ovarian hyperstimulation syndrome (OHSS) development (OR 0.45; 95%CI: 0.30, 0.66; P < 0.0001; I2 = 0%), and the rate of both early OHSS (OR 0.62; 95%CI: 0.43, 0.88; P = 0.008; I2 = 0%) and all forms of OHSS (OR 0.61; 95%CI: 0.44, 0.84; P = 0.003; I2 = 0%) were significantly lower in the group of patients treated with personalized follitropin delta treatment compared to those treated with conventional follitropin alfa/beta administration. Conclusion Personalized follitropin delta treatment is associated with a lower risk of OHSS compared to conventional follitropin alfa/beta administration in potentially normo-responder patients who receive ovarian stimulation in GnRH antagonist IVF/ICSI cycles. The absence of cumulative data does not allow definitive conclusions to be drawn regarding the comparison of the effectiveness of the two treatments. Protocol study registration CRD42023470352 (available at http://www.crd.york.ac.uk/PROSPERO ). |
| first_indexed | 2024-04-24T23:03:24Z |
| format | Article |
| id | doaj.art-2b42677f93e442eb89314b06f2ebbcc4 |
| institution | Directory Open Access Journal |
| issn | 1757-2215 |
| language | English |
| last_indexed | 2024-04-24T23:03:24Z |
| publishDate | 2024-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Journal of Ovarian Research |
| spelling | doaj.art-2b42677f93e442eb89314b06f2ebbcc42024-03-17T12:35:05ZengBMCJournal of Ovarian Research1757-22152024-03-0117112910.1186/s13048-024-01372-wEfficacy and safety of follitropin delta for ovarian stimulation in vitro fertilization/ intracytoplasmic sperm injection cycles: a systematic review with meta-analysisStefano Palomba0Donatella Caserta1Paolo Emanuele Levi-Setti2Andrea Busnelli3Unit of Gynecology, Department of Surgical and Medical Sciences and Translational Medicine, Sant’Andrea Hospital, Sapienza University of RomeUnit of Gynecology, Department of Surgical and Medical Sciences and Translational Medicine, Sant’Andrea Hospital, Sapienza University of RomeDepartment of Biomedical Sciences, Humanitas UniversityDepartment of Biomedical Sciences, Humanitas UniversityAbstract Background Follitropin delta is a novel recombinant follicle stimulating hormone preparation uniquely expressed in a human fetal retinal cell line by recombinant DNA technology. To date, no systematic review was available about the safety and the efficacy of the follitropin delta. The objective of this study was systematically reviewing the available literature and to provide updated evidence regarding the efficacy-safety profile of follitropin delta when compared to other gonadotropin formulations for ovarian stimulation in in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) cycles. Methods An extensive search was performed to identify phase 1, phase 2 and phase 3 RCTs in humans focused on follitropin delta use for ovarian stimulation in IVF/ICSI cycles. The risk of bias and the overall quality of the evidence was analyzed. All data were extracted and analyzed using the intention-to-treat principle and expressed per woman randomized. Results A total of 7 RCTs (1 phase 1 RCT, 2 phase 2 RCTs and 4 phase 3 RCTs) were included in the qualitative analysis, whereas data of three phase 3 RCTs were meta-analyzed. All trials compared personalized recombinant follitropin delta treatment versus conventional recombinant follitropin alfa/beta administration in potentially normo-responder patients who receive ovarian stimulation in GnRH antagonist IVF/ICSI cycles. No difference between two regimens was detected for clinical pregnancy rate [odds ratio (OR) 1.06; 95% confidence intervals (CI): 0.90, 1.24; P = 0.49; I2 = 26%], ongoing pregnancy rate (OR 1.15; 95%CI: 0.90, 1.46; P = 0.27; I2 = 40%), and live birth rate (OR 1.18; 95%CI: 0.89, 1.55; P = 0.25; I2 = 55%). No data were available regarding cumulative success rates. The rate of adoption of strategies to prevent ovarian hyperstimulation syndrome (OHSS) development (OR 0.45; 95%CI: 0.30, 0.66; P < 0.0001; I2 = 0%), and the rate of both early OHSS (OR 0.62; 95%CI: 0.43, 0.88; P = 0.008; I2 = 0%) and all forms of OHSS (OR 0.61; 95%CI: 0.44, 0.84; P = 0.003; I2 = 0%) were significantly lower in the group of patients treated with personalized follitropin delta treatment compared to those treated with conventional follitropin alfa/beta administration. Conclusion Personalized follitropin delta treatment is associated with a lower risk of OHSS compared to conventional follitropin alfa/beta administration in potentially normo-responder patients who receive ovarian stimulation in GnRH antagonist IVF/ICSI cycles. The absence of cumulative data does not allow definitive conclusions to be drawn regarding the comparison of the effectiveness of the two treatments. Protocol study registration CRD42023470352 (available at http://www.crd.york.ac.uk/PROSPERO ).https://doi.org/10.1186/s13048-024-01372-wFollitropin deltaGonadotropinInfertilityIVFOvarian stimulationSterility |
| spellingShingle | Stefano Palomba Donatella Caserta Paolo Emanuele Levi-Setti Andrea Busnelli Efficacy and safety of follitropin delta for ovarian stimulation in vitro fertilization/ intracytoplasmic sperm injection cycles: a systematic review with meta-analysis Journal of Ovarian Research Follitropin delta Gonadotropin Infertility IVF Ovarian stimulation Sterility |
| title | Efficacy and safety of follitropin delta for ovarian stimulation in vitro fertilization/ intracytoplasmic sperm injection cycles: a systematic review with meta-analysis |
| title_full | Efficacy and safety of follitropin delta for ovarian stimulation in vitro fertilization/ intracytoplasmic sperm injection cycles: a systematic review with meta-analysis |
| title_fullStr | Efficacy and safety of follitropin delta for ovarian stimulation in vitro fertilization/ intracytoplasmic sperm injection cycles: a systematic review with meta-analysis |
| title_full_unstemmed | Efficacy and safety of follitropin delta for ovarian stimulation in vitro fertilization/ intracytoplasmic sperm injection cycles: a systematic review with meta-analysis |
| title_short | Efficacy and safety of follitropin delta for ovarian stimulation in vitro fertilization/ intracytoplasmic sperm injection cycles: a systematic review with meta-analysis |
| title_sort | efficacy and safety of follitropin delta for ovarian stimulation in vitro fertilization intracytoplasmic sperm injection cycles a systematic review with meta analysis |
| topic | Follitropin delta Gonadotropin Infertility IVF Ovarian stimulation Sterility |
| url | https://doi.org/10.1186/s13048-024-01372-w |
| work_keys_str_mv | AT stefanopalomba efficacyandsafetyoffollitropindeltaforovarianstimulationinvitrofertilizationintracytoplasmicsperminjectioncyclesasystematicreviewwithmetaanalysis AT donatellacaserta efficacyandsafetyoffollitropindeltaforovarianstimulationinvitrofertilizationintracytoplasmicsperminjectioncyclesasystematicreviewwithmetaanalysis AT paoloemanuelelevisetti efficacyandsafetyoffollitropindeltaforovarianstimulationinvitrofertilizationintracytoplasmicsperminjectioncyclesasystematicreviewwithmetaanalysis AT andreabusnelli efficacyandsafetyoffollitropindeltaforovarianstimulationinvitrofertilizationintracytoplasmicsperminjectioncyclesasystematicreviewwithmetaanalysis |