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    <journal-meta>
      <journal-id journal-id-type="nlm-ta">J Reprod Infert</journal-id>
      <journal-id journal-id-type="publisher-id">arij001</journal-id>
      <journal-title-group>
        <journal-title>Journal of Reproduction &amp; Infertility</journal-title>
      </journal-title-group>
      <issn pub-type="ppub">2228-5482</issn>
      <issn pub-type="epub">2251-676X</issn>
      <publisher>
        <publisher-name>Avicenna Research Institute</publisher-name>
      </publisher>
    </journal-meta>

    <article-meta>
      <article-id pub-id-type="publisher-id">jri120104</article-id>
      <article-id pub-id-type="doi"></article-id>
      <article-id pub-id-type="pmid"></article-id>
      <article-categories>
        <subj-group subj-group-type="heading">
             <subject></subject> 
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            <subject></subject>
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      <title-group>
        <article-title>Clinical Efficacy of Follitropin Alfa in GnRH-Antagonist Protocols: A Prospective Observational Phase IV Study on the Use of Biosimilar Follitropin Alfa r-hFSH in Assisted Reproductive Technology in a Routine Care Setting</article-title>
      </title-group>
        <contrib-group><contrib contrib-type="author"><name><surname>Griesinger</surname><given-names>Georg</given-names></name></contrib><aff>Sektion F&#252;r Gynaekologische Endokrinologie und Reproduktionsmedizin, Klinik F&#252;r Frauenheilkunde &amp; Geburtshilfe (Gynaekologie), Universitaetsklinikum Schleswig-Holstein-Campus Luebeck, Luebeck, Germany</aff></contrib-group><contrib-group><contrib contrib-type="author"><name><surname>Schill</surname><given-names>Thilo</given-names></name></contrib><aff>MVZ Kinderwunschzentrum Langenhagen-Wolfsburg, Langenhagen, Germany</aff></contrib-group><contrib-group><contrib contrib-type="author"><name><surname>Sator</surname><given-names>Michael</given-names></name></contrib><aff>Kinderwunsch im Zentrum GmbH, Tulln an der Donau, Australia</aff></contrib-group><contrib-group><contrib contrib-type="author"><name><surname>Schenk</surname><given-names>Michael</given-names></name></contrib><aff>Das Kinderwunsch Institut Schenk GmbH, Dobl b. Graz, Australia</aff></contrib-group><contrib-group><contrib contrib-type="author"><name><surname>Kr&#252;ssel</surname><given-names>Jan-Steffen</given-names></name></contrib><aff>Universitaeres interdisziplin&#228;res Kinderwunschzentrum Duesseldorf (UniKiD), Klinik f&#252;r Frauenheilkunde und Geburtshilfe, Universit&#228;tsklinikum Duesseldorf, Duesseldorf, Germany</aff></contrib-group>
      <pub-date pub-type="ppub">
        <day></day>
        <month></month>
        <year></year>
      </pub-date>
      <pub-date pub-type="epub">
        <day></day>
        <month></month>
        <year></year>
      </pub-date>
      <volume>22</volume>
      <issue>2</issue>
      <fpage>116</fpage>
      <lpage>125</lpage>
      <history>
        <date date-type="received">
          <day>14</day>
          <month>6</month>
          <year>2020</year>
        </date>
        <date date-type="accepted">
          <day>10</day>
          <month>11</month>
          <year>2020</year>
        </date>
      </history>
      <abstract>
      <p>
      &lt;p&gt;Background: This phase IV routine care study evaluated ovarian responses when using a biosimilar follitropin alfa r-hFSH (Bemfola&lt;sup&gt;&amp;reg;&lt;/sup&gt;) for controlled ovarian stimulation (COS) in women undergoing assisted reproductive technology (ART) treatment who were pituitary-suppressed with a gonadotrophin-releasing hormone (GnRH) antagonist.&lt;br /&gt;
Methods: This multicenter, prospective, non-comparative, non-interventional study (Germany/Austria) was conducted with 885 women (Mean age of 34.0&amp;plusmn;4.4 years) for whom COS with Bemfola&lt;sup&gt;&amp;reg;&lt;/sup&gt; and GnRH-antagonist for pituitary suppression were applied&amp;nbsp; as part of in vitro fertilization (IVF) treatment with/without intracytoplasmic sperm injection (ICSI) observing routine clinical-practice protocols. Primary endpoint was the number of retrieved cumulus-oocyte-complexes (COCs).&lt;br /&gt;
Results: Among 986 ART cycles, COS was given for 9.9&amp;plusmn;1.8 days (First-day r-hFSH dose of 220.7&amp;plusmn;68.9 &lt;em&gt;IU&lt;/em&gt;; mean total dose of 2184.3&amp;plusmn;837.5 &lt;em&gt;IU&lt;/em&gt;). It was revealed that 99.1% of cycles resulted in follicular puncture, with mean of 10.7&amp;plusmn;6.6 oocytes retrieved. Successful fertilization took place after IVF/ICSI in 93.8% of follicular punctures. Freeze-all was performed in 14.2% of cycles. Fresh embryo transfer was performed in 76.9% of cycles with follicular puncture; mean day of transfer was 3.5&amp;plusmn;1.3 and average number of transferred embryos was 1.76&amp;plusmn;0.50. Clinical pregnancy rate was 30.2% of embryo-transfer cycles and 23.4% of started cycles. Sixty-nine reports of ovarian hyperstimulation syndrome (7.0% of started cycles) were documented.&lt;br /&gt;
Conclusion: COS with Bemfola&lt;sup&gt;&amp;reg;&lt;/sup&gt; in GnRH-antagonist IVF/ICSI protocols in a routine care setting led to an appropriate ovarian response allowing oocyte retrieval in 99.1% of initiated cases.&lt;/p&gt;

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      </abstract>
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