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Recombinant Human Follicle-Stimulating Hormone Alfa Dose Adjustment in US Clinical Practice: An Observational, Retrospective Analysis of a Real-World Electronic Medical Records Database
To determine the pattern of dose adjustment of recombinant human follicle-stimulating hormone alfa (r-hFSH-alfa) during ovarian stimulation (OS) for assisted reproductive technology (ART) in a real-world setting. This was an observational, retrospective analysis of data from an electronic de-identif...
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| Published in: | Frontiers in endocrinology (Lausanne) 2021-12, Vol.12, p.742089-742089 |
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| creator | Mahony, Mary C Hayward, Brooke Mottla, Gilbert L Richter, Kevin S Beall, Stephanie Ball, G David D'Hooghe, Thomas |
| description | To determine the pattern of dose adjustment of recombinant human follicle-stimulating hormone alfa (r-hFSH-alfa) during ovarian stimulation (OS) for assisted reproductive technology (ART) in a real-world setting.
This was an observational, retrospective analysis of data from an electronic de-identified medical records database including 39 clinics in the USA. Women undergoing OS for ART (initiated 2009-2016) with r-hFSH-alfa (Gonal-f
or Gonal-f RFF Redi-ject
) were included. Assessed outcomes were patients' baseline characteristics and dosing characteristics/cycle.
Of 33,962 ART cycles, 13,823 (40.7%) underwent dose adjustments: 23.4% with ≥1 dose increase, 25.4% with ≥1 dose decrease, and 8.1% with ≥1 increase and ≥1 decrease. Patients who received dose adjustments were younger (mean [SD] age 34.8 [4.58] years versus 35.9 [4.60] years, p |
| doi_str_mv | 10.3389/fendo.2021.742089 |
| format | article |
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This was an observational, retrospective analysis of data from an electronic de-identified medical records database including 39 clinics in the USA. Women undergoing OS for ART (initiated 2009-2016) with r-hFSH-alfa (Gonal-f
or Gonal-f RFF Redi-ject
) were included. Assessed outcomes were patients' baseline characteristics and dosing characteristics/cycle.
Of 33,962 ART cycles, 13,823 (40.7%) underwent dose adjustments: 23.4% with ≥1 dose increase, 25.4% with ≥1 dose decrease, and 8.1% with ≥1 increase and ≥1 decrease. Patients who received dose adjustments were younger (mean [SD] age 34.8 [4.58] years versus 35.9 [4.60] years, p<0.0001) and had lower BMI (25.1 [5.45] kg/m
versus 25.5 [5.45] kg/m
, p<0.0001) than those who received a constant dose. The proportion of patients with non-normal ovarian reserve was 38.4% for those receiving dose adjustment versus 51.9% for those with a constant dose. The mean (SD) number of dose changes/cycle was 1.61 (0.92) for cycles with any dose adjustment, 1.72 (1.03) for cycles with ≥1 dose increase, 2.77 (1.00) for cycles with ≥1 dose increase and ≥1 decrease (n=2,755), and 1.88 (1.03) for cycles with ≥1 dose decrease.
Dose adjustment during OS is common in clinical practice in the USA and occurred more often in younger versus older patients, those with a high versus non-normal ovarian reserve or those with ovulation disorders/polycystic ovary syndrome versus other primary diagnoses of infertility.</description><identifier>ISSN: 1664-2392</identifier><identifier>EISSN: 1664-2392</identifier><identifier>DOI: 10.3389/fendo.2021.742089</identifier><identifier>PMID: 34956077</identifier><language>eng</language><publisher>Switzerland: Frontiers Media S.A</publisher><subject>Adult ; Age Factors ; assisted reproductive technologies ; Body Mass Index ; Databases, Factual ; dose adjustments ; Endocrinology ; Female ; Follicle Stimulating Hormone, Human - administration & dosage ; Follicle Stimulating Hormone, Human - therapeutic use ; Humans ; infertility ; ovarian stimulation ; Ovulation Induction ; Practice Patterns, Physicians ; r-hFSH- alfa ; Recombinant Proteins - administration & dosage ; Recombinant Proteins - therapeutic use ; Reproductive Techniques, Assisted ; Retrospective Studies ; United States</subject><ispartof>Frontiers in endocrinology (Lausanne), 2021-12, Vol.12, p.742089-742089</ispartof><rights>Copyright © 2021 Mahony, Hayward, Mottla, Richter, Beall, Ball and D’Hooghe.</rights><rights>Copyright © 2021 Mahony, Hayward, Mottla, Richter, Beall, Ball and D’Hooghe 2021 Mahony, Hayward, Mottla, Richter, Beall, Ball and D’Hooghe</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c465t-cfd1f2e4296ccbac8cd30475345987d33275bf0b6fd7f129a7780e66d888bb6e3</citedby><cites>FETCH-LOGICAL-c465t-cfd1f2e4296ccbac8cd30475345987d33275bf0b6fd7f129a7780e66d888bb6e3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8696034/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8696034/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34956077$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mahony, Mary C</creatorcontrib><creatorcontrib>Hayward, Brooke</creatorcontrib><creatorcontrib>Mottla, Gilbert L</creatorcontrib><creatorcontrib>Richter, Kevin S</creatorcontrib><creatorcontrib>Beall, Stephanie</creatorcontrib><creatorcontrib>Ball, G David</creatorcontrib><creatorcontrib>D'Hooghe, Thomas</creatorcontrib><title>Recombinant Human Follicle-Stimulating Hormone Alfa Dose Adjustment in US Clinical Practice: An Observational, Retrospective Analysis of a Real-World Electronic Medical Records Database</title><title>Frontiers in endocrinology (Lausanne)</title><addtitle>Front Endocrinol (Lausanne)</addtitle><description>To determine the pattern of dose adjustment of recombinant human follicle-stimulating hormone alfa (r-hFSH-alfa) during ovarian stimulation (OS) for assisted reproductive technology (ART) in a real-world setting.
This was an observational, retrospective analysis of data from an electronic de-identified medical records database including 39 clinics in the USA. Women undergoing OS for ART (initiated 2009-2016) with r-hFSH-alfa (Gonal-f
or Gonal-f RFF Redi-ject
) were included. Assessed outcomes were patients' baseline characteristics and dosing characteristics/cycle.
Of 33,962 ART cycles, 13,823 (40.7%) underwent dose adjustments: 23.4% with ≥1 dose increase, 25.4% with ≥1 dose decrease, and 8.1% with ≥1 increase and ≥1 decrease. Patients who received dose adjustments were younger (mean [SD] age 34.8 [4.58] years versus 35.9 [4.60] years, p<0.0001) and had lower BMI (25.1 [5.45] kg/m
versus 25.5 [5.45] kg/m
, p<0.0001) than those who received a constant dose. The proportion of patients with non-normal ovarian reserve was 38.4% for those receiving dose adjustment versus 51.9% for those with a constant dose. The mean (SD) number of dose changes/cycle was 1.61 (0.92) for cycles with any dose adjustment, 1.72 (1.03) for cycles with ≥1 dose increase, 2.77 (1.00) for cycles with ≥1 dose increase and ≥1 decrease (n=2,755), and 1.88 (1.03) for cycles with ≥1 dose decrease.
Dose adjustment during OS is common in clinical practice in the USA and occurred more often in younger versus older patients, those with a high versus non-normal ovarian reserve or those with ovulation disorders/polycystic ovary syndrome versus other primary diagnoses of infertility.</description><subject>Adult</subject><subject>Age Factors</subject><subject>assisted reproductive technologies</subject><subject>Body Mass Index</subject><subject>Databases, Factual</subject><subject>dose adjustments</subject><subject>Endocrinology</subject><subject>Female</subject><subject>Follicle Stimulating Hormone, Human - administration & dosage</subject><subject>Follicle Stimulating Hormone, Human - therapeutic use</subject><subject>Humans</subject><subject>infertility</subject><subject>ovarian stimulation</subject><subject>Ovulation Induction</subject><subject>Practice Patterns, Physicians</subject><subject>r-hFSH- alfa</subject><subject>Recombinant Proteins - administration & dosage</subject><subject>Recombinant Proteins - therapeutic use</subject><subject>Reproductive Techniques, Assisted</subject><subject>Retrospective Studies</subject><subject>United States</subject><issn>1664-2392</issn><issn>1664-2392</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>DOA</sourceid><recordid>eNpVkk1vEzEQhlcIRKvSH8AF-ciBTddrrz84IEVpSyoVFbVUHC2vP4Ijrx3s3Uj9afw7nKStWl88mnnn8Xj0VtVH2MwQYvzMmqDjrG1aOKO4bRh_Ux1DQnDdIt6-fREfVac5r5tycAM5Z--rI4R5RxpKj6t_t0bFoXdBhhEsp0EGcBm9d8qb-m50w-Tl6MIKLGMaYjBg7q0E5zGXSK-nPA6m9LkA7u_AwrvglPTgZ5JqdMp8BfMAbvps0rZAYpD-C7g1Y4p5Y4pgWxgl95BdBtECWWrS179j8hpc-KJIsfDAD6P31N2gSWdwLkfZy2w-VO-s9NmcPt4n1f3lxa_Fsr6--X61mF_XCpNurJXV0LYGt5wo1UvFlEYNph3CHWdUI9TSrrdNT6ymFrZcUsoaQ4hmjPU9MeikujpwdZRrsUlukOlBROnEPhHTSsg07hYmMDEEG2oshxyjnrJOWdZjLqGEnSKksL4dWJupH4xWZXlJ-lfQ15Xg_ohV3ApGOGkQLoDPj4AU_04mj2JwWRnvZTBxyqIlsPyNdZQVKTxIVVl4TsY-PwMbsXOQ2DtI7BwkDg4qPZ9ezvfc8eQX9B_T3MaY</recordid><startdate>20211209</startdate><enddate>20211209</enddate><creator>Mahony, Mary C</creator><creator>Hayward, Brooke</creator><creator>Mottla, Gilbert L</creator><creator>Richter, Kevin S</creator><creator>Beall, Stephanie</creator><creator>Ball, G David</creator><creator>D'Hooghe, Thomas</creator><general>Frontiers Media S.A</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope></search><sort><creationdate>20211209</creationdate><title>Recombinant Human Follicle-Stimulating Hormone Alfa Dose Adjustment in US Clinical Practice: An Observational, Retrospective Analysis of a Real-World Electronic Medical Records Database</title><author>Mahony, Mary C ; Hayward, Brooke ; Mottla, Gilbert L ; Richter, Kevin S ; Beall, Stephanie ; Ball, G David ; D'Hooghe, Thomas</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c465t-cfd1f2e4296ccbac8cd30475345987d33275bf0b6fd7f129a7780e66d888bb6e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Adult</topic><topic>Age Factors</topic><topic>assisted reproductive technologies</topic><topic>Body Mass Index</topic><topic>Databases, Factual</topic><topic>dose adjustments</topic><topic>Endocrinology</topic><topic>Female</topic><topic>Follicle Stimulating Hormone, Human - administration & dosage</topic><topic>Follicle Stimulating Hormone, Human - therapeutic use</topic><topic>Humans</topic><topic>infertility</topic><topic>ovarian stimulation</topic><topic>Ovulation Induction</topic><topic>Practice Patterns, Physicians</topic><topic>r-hFSH- alfa</topic><topic>Recombinant Proteins - administration & dosage</topic><topic>Recombinant Proteins - therapeutic use</topic><topic>Reproductive Techniques, Assisted</topic><topic>Retrospective Studies</topic><topic>United States</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mahony, Mary C</creatorcontrib><creatorcontrib>Hayward, Brooke</creatorcontrib><creatorcontrib>Mottla, Gilbert L</creatorcontrib><creatorcontrib>Richter, Kevin S</creatorcontrib><creatorcontrib>Beall, Stephanie</creatorcontrib><creatorcontrib>Ball, G David</creatorcontrib><creatorcontrib>D'Hooghe, Thomas</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>Frontiers in endocrinology (Lausanne)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mahony, Mary C</au><au>Hayward, Brooke</au><au>Mottla, Gilbert L</au><au>Richter, Kevin S</au><au>Beall, Stephanie</au><au>Ball, G David</au><au>D'Hooghe, Thomas</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Recombinant Human Follicle-Stimulating Hormone Alfa Dose Adjustment in US Clinical Practice: An Observational, Retrospective Analysis of a Real-World Electronic Medical Records Database</atitle><jtitle>Frontiers in endocrinology (Lausanne)</jtitle><addtitle>Front Endocrinol (Lausanne)</addtitle><date>2021-12-09</date><risdate>2021</risdate><volume>12</volume><spage>742089</spage><epage>742089</epage><pages>742089-742089</pages><issn>1664-2392</issn><eissn>1664-2392</eissn><abstract>To determine the pattern of dose adjustment of recombinant human follicle-stimulating hormone alfa (r-hFSH-alfa) during ovarian stimulation (OS) for assisted reproductive technology (ART) in a real-world setting.
This was an observational, retrospective analysis of data from an electronic de-identified medical records database including 39 clinics in the USA. Women undergoing OS for ART (initiated 2009-2016) with r-hFSH-alfa (Gonal-f
or Gonal-f RFF Redi-ject
) were included. Assessed outcomes were patients' baseline characteristics and dosing characteristics/cycle.
Of 33,962 ART cycles, 13,823 (40.7%) underwent dose adjustments: 23.4% with ≥1 dose increase, 25.4% with ≥1 dose decrease, and 8.1% with ≥1 increase and ≥1 decrease. Patients who received dose adjustments were younger (mean [SD] age 34.8 [4.58] years versus 35.9 [4.60] years, p<0.0001) and had lower BMI (25.1 [5.45] kg/m
versus 25.5 [5.45] kg/m
, p<0.0001) than those who received a constant dose. The proportion of patients with non-normal ovarian reserve was 38.4% for those receiving dose adjustment versus 51.9% for those with a constant dose. The mean (SD) number of dose changes/cycle was 1.61 (0.92) for cycles with any dose adjustment, 1.72 (1.03) for cycles with ≥1 dose increase, 2.77 (1.00) for cycles with ≥1 dose increase and ≥1 decrease (n=2,755), and 1.88 (1.03) for cycles with ≥1 dose decrease.
Dose adjustment during OS is common in clinical practice in the USA and occurred more often in younger versus older patients, those with a high versus non-normal ovarian reserve or those with ovulation disorders/polycystic ovary syndrome versus other primary diagnoses of infertility.</abstract><cop>Switzerland</cop><pub>Frontiers Media S.A</pub><pmid>34956077</pmid><doi>10.3389/fendo.2021.742089</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
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| source | Open Access: PubMed Central |
| subjects | Adult Age Factors assisted reproductive technologies Body Mass Index Databases, Factual dose adjustments Endocrinology Female Follicle Stimulating Hormone, Human - administration & dosage Follicle Stimulating Hormone, Human - therapeutic use Humans infertility ovarian stimulation Ovulation Induction Practice Patterns, Physicians r-hFSH- alfa Recombinant Proteins - administration & dosage Recombinant Proteins - therapeutic use Reproductive Techniques, Assisted Retrospective Studies United States |
| title | Recombinant Human Follicle-Stimulating Hormone Alfa Dose Adjustment in US Clinical Practice: An Observational, Retrospective Analysis of a Real-World Electronic Medical Records Database |
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