Clinical efficacy and safety of two highly purified human menopausal gonadotropins in women undergoing in vitro fertilization
This study compared the efficacy and safety of two highly purified (HP) human menopausal gonadotropin (hMG) preparations, Gynogen HP and Menopur, in women undergoing controlled ovarian stimulation (COS) for in vitro fertilization (IVF). A multicenter, randomized, active-controlled noninferiority com...
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Bioscientifica
2025-06-01
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| Series: | Reproduction and Fertility |
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| Online Access: | https://raf.bioscientifica.com/view/journals/raf/6/2/RAF-24-0132.xml |
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| author | Kamini A Rao Geeta Khanna Himanshu Bavishi N Sanjeeva Reddy Kajal Mangukiya Renu Jain Kishan PV |
| author_facet | Kamini A Rao Geeta Khanna Himanshu Bavishi N Sanjeeva Reddy Kajal Mangukiya Renu Jain Kishan PV |
| author_sort | Kamini A Rao |
| collection | DOAJ |
| description | This study compared the efficacy and safety of two highly purified (HP) human menopausal gonadotropin (hMG) preparations, Gynogen HP and Menopur, in women undergoing controlled ovarian stimulation (COS) for in vitro fertilization (IVF). A multicenter, randomized, active-controlled noninferiority comparative study was conducted between 2019 and 2021. Women aged 21–40 undergoing COS for their first or second IVF cycle, with or without intracytoplasmic sperm injection, were randomized to receive either Gynogen HP or Menopur. The primary endpoint was to determine the total number of oocytes retrieved. Key secondary endpoints included total hMG dose, days of hMG stimulation, fertilization rate, implantation rate, clinical pregnancy rate and safety. A total of 150 patients were randomized into two groups: 77 received Gynogen HP and 73 received Menopur COS. The primary endpoint, the number of oocytes retrieved (mean ± standard deviation (SD)), was similar between the Gynogen HP (6.3 ± 3.39) and Menopur (6.7 ± 4.52) groups. The least square (LS) mean values were 5.9 for the Gynogen HP and 6.3 for Menopur, with an LS mean difference of – 0.4 (95% CI: −1.83, 1.07; P = 0.6067), indicating that noninferiority as the lower limit of the 95% CI was above the non-inferiority threshold of −2.0. Secondary efficacy endpoints and safety analysis showed no significant differences between groups. Gynogen HP is noninferior and therapeutically equivalent to Menopur in terms of the number of oocytes retrieval, with a comparable safety profile. These results support the use of Gynogen HP for COS in women undergoing IVF as a part of assisted reproduction techniques. |
| format | Article |
| id | doaj-art-b364584b418f4e9a90f4c8074b1b090a |
| institution | Kabale University |
| issn | 2633-8386 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Bioscientifica |
| record_format | Article |
| series | Reproduction and Fertility |
| spelling | doaj-art-b364584b418f4e9a90f4c8074b1b090a2025-08-20T03:46:50ZengBioscientificaReproduction and Fertility2633-83862025-06-016210.1530/RAF-24-01321Clinical efficacy and safety of two highly purified human menopausal gonadotropins in women undergoing in vitro fertilizationKamini A Rao0Geeta Khanna1Himanshu Bavishi2N Sanjeeva Reddy3Kajal Mangukiya4Renu Jain5Kishan PV6Milann Fertility, (A Unit of BACC Healthcare), Bangalore, Karnataka, IndiaAjanta Hospital & IVF Centre, Lucknow, Uttar Pradesh, IndiaBavishi Fertility Institute, Ahmedabad, Gujarat, IndiaDepartment of Reproductive Medicine & Surgery, Sri Ramachandra Medical Centre, Chennai, Tamil Nadu, IndiaOrkid Medilife Pvt Ltd, Surat, Gujarat, IndiaGP Shekhawati Hospital, Jaipur, Rajasthan, IndiaSanzyme P Ltd, Hyderabad, Telangana, IndiaThis study compared the efficacy and safety of two highly purified (HP) human menopausal gonadotropin (hMG) preparations, Gynogen HP and Menopur, in women undergoing controlled ovarian stimulation (COS) for in vitro fertilization (IVF). A multicenter, randomized, active-controlled noninferiority comparative study was conducted between 2019 and 2021. Women aged 21–40 undergoing COS for their first or second IVF cycle, with or without intracytoplasmic sperm injection, were randomized to receive either Gynogen HP or Menopur. The primary endpoint was to determine the total number of oocytes retrieved. Key secondary endpoints included total hMG dose, days of hMG stimulation, fertilization rate, implantation rate, clinical pregnancy rate and safety. A total of 150 patients were randomized into two groups: 77 received Gynogen HP and 73 received Menopur COS. The primary endpoint, the number of oocytes retrieved (mean ± standard deviation (SD)), was similar between the Gynogen HP (6.3 ± 3.39) and Menopur (6.7 ± 4.52) groups. The least square (LS) mean values were 5.9 for the Gynogen HP and 6.3 for Menopur, with an LS mean difference of – 0.4 (95% CI: −1.83, 1.07; P = 0.6067), indicating that noninferiority as the lower limit of the 95% CI was above the non-inferiority threshold of −2.0. Secondary efficacy endpoints and safety analysis showed no significant differences between groups. Gynogen HP is noninferior and therapeutically equivalent to Menopur in terms of the number of oocytes retrieval, with a comparable safety profile. These results support the use of Gynogen HP for COS in women undergoing IVF as a part of assisted reproduction techniques.https://raf.bioscientifica.com/view/journals/raf/6/2/RAF-24-0132.xmlcontrolled ovarian stimulationgynogen hphuman menopausal gonadotropinsin vitro fertilizationmenopur |
| spellingShingle | Kamini A Rao Geeta Khanna Himanshu Bavishi N Sanjeeva Reddy Kajal Mangukiya Renu Jain Kishan PV Clinical efficacy and safety of two highly purified human menopausal gonadotropins in women undergoing in vitro fertilization Reproduction and Fertility controlled ovarian stimulation gynogen hp human menopausal gonadotropins in vitro fertilization menopur |
| title | Clinical efficacy and safety of two highly purified human menopausal gonadotropins in women undergoing in vitro fertilization |
| title_full | Clinical efficacy and safety of two highly purified human menopausal gonadotropins in women undergoing in vitro fertilization |
| title_fullStr | Clinical efficacy and safety of two highly purified human menopausal gonadotropins in women undergoing in vitro fertilization |
| title_full_unstemmed | Clinical efficacy and safety of two highly purified human menopausal gonadotropins in women undergoing in vitro fertilization |
| title_short | Clinical efficacy and safety of two highly purified human menopausal gonadotropins in women undergoing in vitro fertilization |
| title_sort | clinical efficacy and safety of two highly purified human menopausal gonadotropins in women undergoing in vitro fertilization |
| topic | controlled ovarian stimulation gynogen hp human menopausal gonadotropins in vitro fertilization menopur |
| url | https://raf.bioscientifica.com/view/journals/raf/6/2/RAF-24-0132.xml |
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