Clinical Outcomes in Patients Receiving Originator Follitropin Alfa and Follitropin Alfa Biosimilars in Real-world Clinical Practice: A Retrospective Study
Background: Biosimilar drugs have broadened the treatment options in assisted reproductive technology (ART). Real-world data comparing clinical outcomes of originator follitropin alfa (Gonal-f®) with its biosimilars are required to enrich the body of evidence for clinical decision-making on choice o...
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| Format: | Article |
| Language: | English |
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Wolters Kluwer Medknow Publications
2023-04-01
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| Series: | Journal of Human Reproductive Sciences |
| Subjects: | |
| Online Access: | https://journals.lww.com/10.4103/jhrs.jhrs_37_23 |
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| author | Nayana Hitesh Patel Niket H. Patel Molina Niket Patel Harsha K. Bhadarka Kairavi Sunilkumar Vyas |
| author_facet | Nayana Hitesh Patel Niket H. Patel Molina Niket Patel Harsha K. Bhadarka Kairavi Sunilkumar Vyas |
| author_sort | Nayana Hitesh Patel |
| collection | DOAJ |
| description | Background:
Biosimilar drugs have broadened the treatment options in assisted reproductive technology (ART). Real-world data comparing clinical outcomes of originator follitropin alfa (Gonal-f®) with its biosimilars are required to enrich the body of evidence for clinical decision-making on choice of drug.
Aims:
To compare the ART outcomes in patients receiving originator follitropin (Gonal-f®) and its biosimilars in clinical setting.
Settings and Design:
Medical records of 364 infertile women who underwent ART between 2016 and 2020 at Akanksha Hospital and Research Institute, Gujrat, India, were retrospectively analysed.
Materials and Methods:
Participants were divided into two cohorts based on treatment (Gonal-f® cohort; N = 174 and biosimilar cohort; N = 190), each cohort further subdivided into group A (age <35 years) and group B (age ≥35 years). Fresh or frozen embryo transfer was performed as per the standard procedures of the clinic. Pregnancy rates and live birth rate (LBR) were the primary main outcome measures in this study.
Statistical Analysis Used:
Descriptive statistics and Chi-square test were used for analysis.
Results:
The number of oocytes retrieved from Gonal-f® and biosimilar cohorts were comparable (13.3 vs. 14.4). Compared to biosimilars, Gonal-f® treatment resulted in higher yield of cleavage stage and blastocyst stage embryos, and the proportion of women with good quality embryos was higher in the Gonal-f® cohort than the biosimilar cohort (83.3% vs. 69.5%). Patients receiving Gonal-f® reported higher pregnancy rates (59.2% vs. 39.7%) and LBR (43% vs. 17.7%) compared to those receiving biosimilars.
Conclusions:
Gonal-f® (originator follitropin) treatment could result in higher pregnancy rates and LBR in comparison to biosimilars in real-world setting. |
| format | Article |
| id | doaj-art-860e765bbb294279923c50517516ec08 |
| institution | Kabale University |
| issn | 0974-1208 1998-4766 |
| language | English |
| publishDate | 2023-04-01 |
| publisher | Wolters Kluwer Medknow Publications |
| record_format | Article |
| series | Journal of Human Reproductive Sciences |
| spelling | doaj-art-860e765bbb294279923c50517516ec082025-02-10T07:44:08ZengWolters Kluwer Medknow PublicationsJournal of Human Reproductive Sciences0974-12081998-47662023-04-0116214815510.4103/jhrs.jhrs_37_23Clinical Outcomes in Patients Receiving Originator Follitropin Alfa and Follitropin Alfa Biosimilars in Real-world Clinical Practice: A Retrospective StudyNayana Hitesh PatelNiket H. PatelMolina Niket PatelHarsha K. BhadarkaKairavi Sunilkumar VyasBackground: Biosimilar drugs have broadened the treatment options in assisted reproductive technology (ART). Real-world data comparing clinical outcomes of originator follitropin alfa (Gonal-f®) with its biosimilars are required to enrich the body of evidence for clinical decision-making on choice of drug. Aims: To compare the ART outcomes in patients receiving originator follitropin (Gonal-f®) and its biosimilars in clinical setting. Settings and Design: Medical records of 364 infertile women who underwent ART between 2016 and 2020 at Akanksha Hospital and Research Institute, Gujrat, India, were retrospectively analysed. Materials and Methods: Participants were divided into two cohorts based on treatment (Gonal-f® cohort; N = 174 and biosimilar cohort; N = 190), each cohort further subdivided into group A (age <35 years) and group B (age ≥35 years). Fresh or frozen embryo transfer was performed as per the standard procedures of the clinic. Pregnancy rates and live birth rate (LBR) were the primary main outcome measures in this study. Statistical Analysis Used: Descriptive statistics and Chi-square test were used for analysis. Results: The number of oocytes retrieved from Gonal-f® and biosimilar cohorts were comparable (13.3 vs. 14.4). Compared to biosimilars, Gonal-f® treatment resulted in higher yield of cleavage stage and blastocyst stage embryos, and the proportion of women with good quality embryos was higher in the Gonal-f® cohort than the biosimilar cohort (83.3% vs. 69.5%). Patients receiving Gonal-f® reported higher pregnancy rates (59.2% vs. 39.7%) and LBR (43% vs. 17.7%) compared to those receiving biosimilars. Conclusions: Gonal-f® (originator follitropin) treatment could result in higher pregnancy rates and LBR in comparison to biosimilars in real-world setting.https://journals.lww.com/10.4103/jhrs.jhrs_37_23assisted reproductive technologyfollitropin alfagonadotropin-releasing hormone antagonistinfertility |
| spellingShingle | Nayana Hitesh Patel Niket H. Patel Molina Niket Patel Harsha K. Bhadarka Kairavi Sunilkumar Vyas Clinical Outcomes in Patients Receiving Originator Follitropin Alfa and Follitropin Alfa Biosimilars in Real-world Clinical Practice: A Retrospective Study Journal of Human Reproductive Sciences assisted reproductive technology follitropin alfa gonadotropin-releasing hormone antagonist infertility |
| title | Clinical Outcomes in Patients Receiving Originator Follitropin Alfa and Follitropin Alfa Biosimilars in Real-world Clinical Practice: A Retrospective Study |
| title_full | Clinical Outcomes in Patients Receiving Originator Follitropin Alfa and Follitropin Alfa Biosimilars in Real-world Clinical Practice: A Retrospective Study |
| title_fullStr | Clinical Outcomes in Patients Receiving Originator Follitropin Alfa and Follitropin Alfa Biosimilars in Real-world Clinical Practice: A Retrospective Study |
| title_full_unstemmed | Clinical Outcomes in Patients Receiving Originator Follitropin Alfa and Follitropin Alfa Biosimilars in Real-world Clinical Practice: A Retrospective Study |
| title_short | Clinical Outcomes in Patients Receiving Originator Follitropin Alfa and Follitropin Alfa Biosimilars in Real-world Clinical Practice: A Retrospective Study |
| title_sort | clinical outcomes in patients receiving originator follitropin alfa and follitropin alfa biosimilars in real world clinical practice a retrospective study |
| topic | assisted reproductive technology follitropin alfa gonadotropin-releasing hormone antagonist infertility |
| url | https://journals.lww.com/10.4103/jhrs.jhrs_37_23 |
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