Randomized, controlled, open-label, non-inferiority study of the CONSORT algorithm for individualized dosing of follitropin alfa
Abstract In this randomized, controlled, open-label, phase IV study, ovarian response after a follitropin alfa starting dose determined by the CONSORT calculator was compared with a standard dose (150 IU). Normo-ovulatory women (aged 18–34 years) eligible for assisted reproductive techniques were re...
Gespeichert in:
| Veröffentlicht in: | Reproductive biomedicine online 2015-03, Vol.30 (3), p.248-257 |
|---|---|
| Hauptverfasser: | , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 257 |
|---|---|
| container_issue | 3 |
| container_start_page | 248 |
| container_title | Reproductive biomedicine online |
| container_volume | 30 |
| creator | Olivennes, F Trew, G Borini, A Broekmans, F Arriagada, P Warne, D.W Howles, C.M |
| description | Abstract In this randomized, controlled, open-label, phase IV study, ovarian response after a follitropin alfa starting dose determined by the CONSORT calculator was compared with a standard dose (150 IU). Normo-ovulatory women (aged 18–34 years) eligible for assisted reproductive techniques were recruited (23 centres: nine European countries and Chile); 200 women were randomized (CONSORT [ n = 96]; standard dosing [ n = 104]). Significantly lower mean daily (121.5 versus 167.4 IU; P < 0.001) and total (1288.5 versus 1810.0 IU; P < 0.001) doses of follitropin alfa were administered in the CONSORT group. Clinical pregnancy rates were CONSORT (36.0%) and standard dosing (35.5%); estimated difference (confidence interval 0.6%; −13.5 to 14.6). Ovarian hyperstimulation syndrome occurred in 6.3% and 12.5% of patients in the CONSORT and standard-dosing groups, respectively. The primary efficacy analysis found a significantly lower mean [SD] number of oocytes retrieved in the CONSORT (10.0 [5.6]; P = 0.037) versus standard-dosing group (11.8 [5.3]). Although the CONSORT calculator was statistically inferior to standard dosing in the number of oocytes retrieved, clinical pregnancy rates (fresh embryo transfers) were similar in both groups, and incidence of ovarian hyperstimulation syndrome was lower in the CONSORT group. |
| doi_str_mv | 10.1016/j.rbmo.2014.11.013 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1661333955</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S1472648314006439</els_id><sourcerecordid>1661333955</sourcerecordid><originalsourceid>FETCH-LOGICAL-c525t-464b7f3aad65e60920c1f462d39faa453ef308e94374c1e4acf7d364c78bd9673</originalsourceid><addsrcrecordid>eNp9kc1u1DAURiMEoqXwAiyQlyya4Bs7TiIhpGrEn1QxUlvWlmNftx4ce7CTSsOKRyfRlC5YsPKV_J3P8rlF8RpoBRTEu12VhjFWNQVeAVQU2JPiFHhbl4L38PRx7thJ8SLnHaXQ0Y49L07qpulFD_S0-H2lgomj-4XmnOgYphS9X-e4x1B6NaA_JyGG0gWLycXkpgPJ02wOJFoy3SHZbL9db69uiPK36-3dSGxMxAXj7p2ZlV-riYnZhdsVsUu_W17Zu7AgVr0snlnlM756OM-K758-3my-lJfbz183F5elbupmKrngQ2uZUkY0KGhfUw2Wi9qw3irFG4aW0Q57zlquAbnStjVMcN12g-lFy86Kt8fefYo_Z8yTHF3W6L0KGOcsQQhgjPVNs0TrY1SnmHNCK_fJjSodJFC5mpc7uZqXq3kJIBfzC_TmoX8eRjSPyF_VS-D9MYDLL-8dJpm1w6DRuIR6kia6__d_-AfX3gWnlf-BB8y7OKew-JMgcy2pvF53v64eOKWCs579AUG0qzs</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1661333955</pqid></control><display><type>article</type><title>Randomized, controlled, open-label, non-inferiority study of the CONSORT algorithm for individualized dosing of follitropin alfa</title><source>MEDLINE</source><source>ScienceDirect Journals (5 years ago - present)</source><creator>Olivennes, F ; Trew, G ; Borini, A ; Broekmans, F ; Arriagada, P ; Warne, D.W ; Howles, C.M</creator><creatorcontrib>Olivennes, F ; Trew, G ; Borini, A ; Broekmans, F ; Arriagada, P ; Warne, D.W ; Howles, C.M</creatorcontrib><description>Abstract In this randomized, controlled, open-label, phase IV study, ovarian response after a follitropin alfa starting dose determined by the CONSORT calculator was compared with a standard dose (150 IU). Normo-ovulatory women (aged 18–34 years) eligible for assisted reproductive techniques were recruited (23 centres: nine European countries and Chile); 200 women were randomized (CONSORT [ n = 96]; standard dosing [ n = 104]). Significantly lower mean daily (121.5 versus 167.4 IU; P < 0.001) and total (1288.5 versus 1810.0 IU; P < 0.001) doses of follitropin alfa were administered in the CONSORT group. Clinical pregnancy rates were CONSORT (36.0%) and standard dosing (35.5%); estimated difference (confidence interval 0.6%; −13.5 to 14.6). Ovarian hyperstimulation syndrome occurred in 6.3% and 12.5% of patients in the CONSORT and standard-dosing groups, respectively. The primary efficacy analysis found a significantly lower mean [SD] number of oocytes retrieved in the CONSORT (10.0 [5.6]; P = 0.037) versus standard-dosing group (11.8 [5.3]). Although the CONSORT calculator was statistically inferior to standard dosing in the number of oocytes retrieved, clinical pregnancy rates (fresh embryo transfers) were similar in both groups, and incidence of ovarian hyperstimulation syndrome was lower in the CONSORT group.</description><identifier>ISSN: 1472-6483</identifier><identifier>EISSN: 1472-6491</identifier><identifier>DOI: 10.1016/j.rbmo.2014.11.013</identifier><identifier>PMID: 25596910</identifier><language>eng</language><publisher>Netherlands: Elsevier Ltd</publisher><subject>Adolescent ; Adult ; algorithm ; Algorithms ; anti-Müllerian hormone ; antral follicle count ; assisted reproductive technology ; Chile - epidemiology ; Drug Dosage Calculations ; Embryo Transfer ; Europe - epidemiology ; Female ; Fertility Agents, Female - administration & dosage ; Fertility Agents, Female - adverse effects ; Fertility Agents, Female - therapeutic use ; Fertilization in Vitro ; Follicle Stimulating Hormone, Human - administration & dosage ; Follicle Stimulating Hormone, Human - adverse effects ; Follicle Stimulating Hormone, Human - therapeutic use ; Humans ; Incidence ; Infertility, Female - physiopathology ; Infertility, Female - therapy ; Intention to Treat Analysis ; Obstetrics and Gynecology ; Oocyte Retrieval ; Ovarian Hyperstimulation Syndrome - chemically induced ; Ovarian Hyperstimulation Syndrome - epidemiology ; Ovarian Hyperstimulation Syndrome - prevention & control ; Ovulation Induction - adverse effects ; Precision Medicine ; Pregnancy ; Pregnancy Rate ; recombinant human follicle-stimulating hormone ; Recombinant Proteins - administration & dosage ; Recombinant Proteins - adverse effects ; Recombinant Proteins - therapeutic use ; Young Adult</subject><ispartof>Reproductive biomedicine online, 2015-03, Vol.30 (3), p.248-257</ispartof><rights>Reproductive Healthcare Ltd.</rights><rights>2014 Reproductive Healthcare Ltd.</rights><rights>Copyright © 2014 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c525t-464b7f3aad65e60920c1f462d39faa453ef308e94374c1e4acf7d364c78bd9673</citedby><cites>FETCH-LOGICAL-c525t-464b7f3aad65e60920c1f462d39faa453ef308e94374c1e4acf7d364c78bd9673</cites><orcidid>0000-0002-0490-0618</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.rbmo.2014.11.013$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3548,27923,27924,45994</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25596910$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Olivennes, F</creatorcontrib><creatorcontrib>Trew, G</creatorcontrib><creatorcontrib>Borini, A</creatorcontrib><creatorcontrib>Broekmans, F</creatorcontrib><creatorcontrib>Arriagada, P</creatorcontrib><creatorcontrib>Warne, D.W</creatorcontrib><creatorcontrib>Howles, C.M</creatorcontrib><title>Randomized, controlled, open-label, non-inferiority study of the CONSORT algorithm for individualized dosing of follitropin alfa</title><title>Reproductive biomedicine online</title><addtitle>Reprod Biomed Online</addtitle><description>Abstract In this randomized, controlled, open-label, phase IV study, ovarian response after a follitropin alfa starting dose determined by the CONSORT calculator was compared with a standard dose (150 IU). Normo-ovulatory women (aged 18–34 years) eligible for assisted reproductive techniques were recruited (23 centres: nine European countries and Chile); 200 women were randomized (CONSORT [ n = 96]; standard dosing [ n = 104]). Significantly lower mean daily (121.5 versus 167.4 IU; P < 0.001) and total (1288.5 versus 1810.0 IU; P < 0.001) doses of follitropin alfa were administered in the CONSORT group. Clinical pregnancy rates were CONSORT (36.0%) and standard dosing (35.5%); estimated difference (confidence interval 0.6%; −13.5 to 14.6). Ovarian hyperstimulation syndrome occurred in 6.3% and 12.5% of patients in the CONSORT and standard-dosing groups, respectively. The primary efficacy analysis found a significantly lower mean [SD] number of oocytes retrieved in the CONSORT (10.0 [5.6]; P = 0.037) versus standard-dosing group (11.8 [5.3]). Although the CONSORT calculator was statistically inferior to standard dosing in the number of oocytes retrieved, clinical pregnancy rates (fresh embryo transfers) were similar in both groups, and incidence of ovarian hyperstimulation syndrome was lower in the CONSORT group.</description><subject>Adolescent</subject><subject>Adult</subject><subject>algorithm</subject><subject>Algorithms</subject><subject>anti-Müllerian hormone</subject><subject>antral follicle count</subject><subject>assisted reproductive technology</subject><subject>Chile - epidemiology</subject><subject>Drug Dosage Calculations</subject><subject>Embryo Transfer</subject><subject>Europe - epidemiology</subject><subject>Female</subject><subject>Fertility Agents, Female - administration & dosage</subject><subject>Fertility Agents, Female - adverse effects</subject><subject>Fertility Agents, Female - therapeutic use</subject><subject>Fertilization in Vitro</subject><subject>Follicle Stimulating Hormone, Human - administration & dosage</subject><subject>Follicle Stimulating Hormone, Human - adverse effects</subject><subject>Follicle Stimulating Hormone, Human - therapeutic use</subject><subject>Humans</subject><subject>Incidence</subject><subject>Infertility, Female - physiopathology</subject><subject>Infertility, Female - therapy</subject><subject>Intention to Treat Analysis</subject><subject>Obstetrics and Gynecology</subject><subject>Oocyte Retrieval</subject><subject>Ovarian Hyperstimulation Syndrome - chemically induced</subject><subject>Ovarian Hyperstimulation Syndrome - epidemiology</subject><subject>Ovarian Hyperstimulation Syndrome - prevention & control</subject><subject>Ovulation Induction - adverse effects</subject><subject>Precision Medicine</subject><subject>Pregnancy</subject><subject>Pregnancy Rate</subject><subject>recombinant human follicle-stimulating hormone</subject><subject>Recombinant Proteins - administration & dosage</subject><subject>Recombinant Proteins - adverse effects</subject><subject>Recombinant Proteins - therapeutic use</subject><subject>Young Adult</subject><issn>1472-6483</issn><issn>1472-6491</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kc1u1DAURiMEoqXwAiyQlyya4Bs7TiIhpGrEn1QxUlvWlmNftx4ce7CTSsOKRyfRlC5YsPKV_J3P8rlF8RpoBRTEu12VhjFWNQVeAVQU2JPiFHhbl4L38PRx7thJ8SLnHaXQ0Y49L07qpulFD_S0-H2lgomj-4XmnOgYphS9X-e4x1B6NaA_JyGG0gWLycXkpgPJ02wOJFoy3SHZbL9db69uiPK36-3dSGxMxAXj7p2ZlV-riYnZhdsVsUu_W17Zu7AgVr0snlnlM756OM-K758-3my-lJfbz183F5elbupmKrngQ2uZUkY0KGhfUw2Wi9qw3irFG4aW0Q57zlquAbnStjVMcN12g-lFy86Kt8fefYo_Z8yTHF3W6L0KGOcsQQhgjPVNs0TrY1SnmHNCK_fJjSodJFC5mpc7uZqXq3kJIBfzC_TmoX8eRjSPyF_VS-D9MYDLL-8dJpm1w6DRuIR6kia6__d_-AfX3gWnlf-BB8y7OKew-JMgcy2pvF53v64eOKWCs579AUG0qzs</recordid><startdate>20150301</startdate><enddate>20150301</enddate><creator>Olivennes, F</creator><creator>Trew, G</creator><creator>Borini, A</creator><creator>Broekmans, F</creator><creator>Arriagada, P</creator><creator>Warne, D.W</creator><creator>Howles, C.M</creator><general>Elsevier Ltd</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><orcidid>https://orcid.org/0000-0002-0490-0618</orcidid></search><sort><creationdate>20150301</creationdate><title>Randomized, controlled, open-label, non-inferiority study of the CONSORT algorithm for individualized dosing of follitropin alfa</title><author>Olivennes, F ; Trew, G ; Borini, A ; Broekmans, F ; Arriagada, P ; Warne, D.W ; Howles, C.M</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c525t-464b7f3aad65e60920c1f462d39faa453ef308e94374c1e4acf7d364c78bd9673</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>algorithm</topic><topic>Algorithms</topic><topic>anti-Müllerian hormone</topic><topic>antral follicle count</topic><topic>assisted reproductive technology</topic><topic>Chile - epidemiology</topic><topic>Drug Dosage Calculations</topic><topic>Embryo Transfer</topic><topic>Europe - epidemiology</topic><topic>Female</topic><topic>Fertility Agents, Female - administration & dosage</topic><topic>Fertility Agents, Female - adverse effects</topic><topic>Fertility Agents, Female - therapeutic use</topic><topic>Fertilization in Vitro</topic><topic>Follicle Stimulating Hormone, Human - administration & dosage</topic><topic>Follicle Stimulating Hormone, Human - adverse effects</topic><topic>Follicle Stimulating Hormone, Human - therapeutic use</topic><topic>Humans</topic><topic>Incidence</topic><topic>Infertility, Female - physiopathology</topic><topic>Infertility, Female - therapy</topic><topic>Intention to Treat Analysis</topic><topic>Obstetrics and Gynecology</topic><topic>Oocyte Retrieval</topic><topic>Ovarian Hyperstimulation Syndrome - chemically induced</topic><topic>Ovarian Hyperstimulation Syndrome - epidemiology</topic><topic>Ovarian Hyperstimulation Syndrome - prevention & control</topic><topic>Ovulation Induction - adverse effects</topic><topic>Precision Medicine</topic><topic>Pregnancy</topic><topic>Pregnancy Rate</topic><topic>recombinant human follicle-stimulating hormone</topic><topic>Recombinant Proteins - administration & dosage</topic><topic>Recombinant Proteins - adverse effects</topic><topic>Recombinant Proteins - therapeutic use</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Olivennes, F</creatorcontrib><creatorcontrib>Trew, G</creatorcontrib><creatorcontrib>Borini, A</creatorcontrib><creatorcontrib>Broekmans, F</creatorcontrib><creatorcontrib>Arriagada, P</creatorcontrib><creatorcontrib>Warne, D.W</creatorcontrib><creatorcontrib>Howles, C.M</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><jtitle>Reproductive biomedicine online</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Olivennes, F</au><au>Trew, G</au><au>Borini, A</au><au>Broekmans, F</au><au>Arriagada, P</au><au>Warne, D.W</au><au>Howles, C.M</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomized, controlled, open-label, non-inferiority study of the CONSORT algorithm for individualized dosing of follitropin alfa</atitle><jtitle>Reproductive biomedicine online</jtitle><addtitle>Reprod Biomed Online</addtitle><date>2015-03-01</date><risdate>2015</risdate><volume>30</volume><issue>3</issue><spage>248</spage><epage>257</epage><pages>248-257</pages><issn>1472-6483</issn><eissn>1472-6491</eissn><abstract>Abstract In this randomized, controlled, open-label, phase IV study, ovarian response after a follitropin alfa starting dose determined by the CONSORT calculator was compared with a standard dose (150 IU). Normo-ovulatory women (aged 18–34 years) eligible for assisted reproductive techniques were recruited (23 centres: nine European countries and Chile); 200 women were randomized (CONSORT [ n = 96]; standard dosing [ n = 104]). Significantly lower mean daily (121.5 versus 167.4 IU; P < 0.001) and total (1288.5 versus 1810.0 IU; P < 0.001) doses of follitropin alfa were administered in the CONSORT group. Clinical pregnancy rates were CONSORT (36.0%) and standard dosing (35.5%); estimated difference (confidence interval 0.6%; −13.5 to 14.6). Ovarian hyperstimulation syndrome occurred in 6.3% and 12.5% of patients in the CONSORT and standard-dosing groups, respectively. The primary efficacy analysis found a significantly lower mean [SD] number of oocytes retrieved in the CONSORT (10.0 [5.6]; P = 0.037) versus standard-dosing group (11.8 [5.3]). Although the CONSORT calculator was statistically inferior to standard dosing in the number of oocytes retrieved, clinical pregnancy rates (fresh embryo transfers) were similar in both groups, and incidence of ovarian hyperstimulation syndrome was lower in the CONSORT group.</abstract><cop>Netherlands</cop><pub>Elsevier Ltd</pub><pmid>25596910</pmid><doi>10.1016/j.rbmo.2014.11.013</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-0490-0618</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1472-6483 |
| ispartof | Reproductive biomedicine online, 2015-03, Vol.30 (3), p.248-257 |
| issn | 1472-6483 1472-6491 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_1661333955 |
| source | MEDLINE; ScienceDirect Journals (5 years ago - present) |
| subjects | Adolescent Adult algorithm Algorithms anti-Müllerian hormone antral follicle count assisted reproductive technology Chile - epidemiology Drug Dosage Calculations Embryo Transfer Europe - epidemiology Female Fertility Agents, Female - administration & dosage Fertility Agents, Female - adverse effects Fertility Agents, Female - therapeutic use Fertilization in Vitro Follicle Stimulating Hormone, Human - administration & dosage Follicle Stimulating Hormone, Human - adverse effects Follicle Stimulating Hormone, Human - therapeutic use Humans Incidence Infertility, Female - physiopathology Infertility, Female - therapy Intention to Treat Analysis Obstetrics and Gynecology Oocyte Retrieval Ovarian Hyperstimulation Syndrome - chemically induced Ovarian Hyperstimulation Syndrome - epidemiology Ovarian Hyperstimulation Syndrome - prevention & control Ovulation Induction - adverse effects Precision Medicine Pregnancy Pregnancy Rate recombinant human follicle-stimulating hormone Recombinant Proteins - administration & dosage Recombinant Proteins - adverse effects Recombinant Proteins - therapeutic use Young Adult |
| title | Randomized, controlled, open-label, non-inferiority study of the CONSORT algorithm for individualized dosing of follitropin alfa |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-12T02%3A39%3A40IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Randomized,%20controlled,%20open-label,%20non-inferiority%20study%20of%20the%20CONSORT%20algorithm%20for%20individualized%20dosing%20of%20follitropin%20alfa&rft.jtitle=Reproductive%20biomedicine%20online&rft.au=Olivennes,%20F&rft.date=2015-03-01&rft.volume=30&rft.issue=3&rft.spage=248&rft.epage=257&rft.pages=248-257&rft.issn=1472-6483&rft.eissn=1472-6491&rft_id=info:doi/10.1016/j.rbmo.2014.11.013&rft_dat=%3Cproquest_cross%3E1661333955%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1661333955&rft_id=info:pmid/25596910&rft_els_id=S1472648314006439&rfr_iscdi=true |