<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02992808</url>
  </required_header>
  <id_info>
    <org_study_id>SHEBA-16-3516-EZ-CTIL</org_study_id>
    <nct_id>NCT02992808</nct_id>
  </id_info>
  <brief_title>Androgenic Profile Following Controlled Ovarian Stimulation</brief_title>
  <official_title>Follicular Fluid, Serum Endocrine Profile Following Stimulation With Recombinant Gonadotropins or Highly Purified Human Menopausal Gonadotropin During GnRH-antagonist Protocol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheba Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study the investigators will try to discover whether there is a difference for any of&#xD;
      the stimulation preparations - recombinant FSH + recombinant LH (pergoveris &amp; luveris) vs.&#xD;
      human menopausal gonadotropin (menopur) during GnRH-antagonist cycles in the meaning of&#xD;
      androgenic hormones profile. The study question is whether using recombinant LH will result&#xD;
      in different follicular hormonal milieu, serum endocrine profile or IVF outcomes than using&#xD;
      highly purified urinary gonadotropins with hCG mimicking LH activity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ABSTRACT:&#xD;
&#xD;
      The optimal controlled ovarian stimulation (COH) protocol is yet to be decided and most&#xD;
      probably there is no right protocol that is optimal for all patients.&#xD;
&#xD;
      The role of luteinizing hormone (LH) administration during controlled ovarian stimulation&#xD;
      (COH) is widely debated in the current medical literature.&#xD;
&#xD;
      Until recently the only source for exogenous LH activity was HMG preparations, however, in&#xD;
      the past few years an advancement in the field of recombinant technology resulted in&#xD;
      recombinant preparations of LH. In contrast to LH activity in HMG which is mainly due to hCG&#xD;
      rather than from LH, using r-LH provides true, consistent and precise LH activity.&#xD;
&#xD;
      In the past years few papers were published about the difference between recombinant follicle&#xD;
      stimulating hormone (r-FSH) and menotropins but there is still a need for researching the&#xD;
      different effects of gonadotropins preparations and in particular the effect of LH&#xD;
      administration during COH in the manner of follicular endocrine characteristics, embryo&#xD;
      quality and pregnancy outcomes.&#xD;
&#xD;
      In the present study the investigators aim to elucidate whether there is a difference for any&#xD;
      of the stimulation preparations - recombinant FSH + recombinant LH (pergoveris &amp; luveris) vs.&#xD;
      human menopausal gonadotropin (menopur) during GnRH-antagonist cycles. The study question is&#xD;
      whether using recombinant LH will result in different follicular hormonal milieu, serum&#xD;
      endocrine profile or IVF outcomes than using highly purified urinary gonadotropins with hCG&#xD;
      mimicking LH activity.&#xD;
&#xD;
      In the relevant medical literature there is one prospective study dealing with the same&#xD;
      question, but, during long-GnRH-agonist cycles. In the aforementioned paper there were no&#xD;
      significant differences between the two stimulation preparations.&#xD;
&#xD;
      MATERIALS &amp; METHODS:&#xD;
&#xD;
      Study design - A non-intervention observational trial. Primary endpoint - Serum &amp; follicular&#xD;
      fluid hormonal profile during COH (FSH, LH, progesterone, estradiol, testosterone,&#xD;
      androstendione, 17-OH progesterone) Secondary endpoints - Implantation rate, clinical&#xD;
      pregnancy, # of follicles, # of oocytes, # of embryos, top quality embryos.&#xD;
&#xD;
      Study sample - 100 patients undergoing COH for IVF using the GnRH-antagonist protocol&#xD;
      Inclusion criteria - 20-40 years old IVF patients, BMI 19-35 undergoing their 1-4 IVF cycle.&#xD;
&#xD;
      Exclusion criteria - Suspected PCOS, history of OHSS, Patients who had a chronic illness or&#xD;
      were receiving chronic medical treatment will be excluded.&#xD;
&#xD;
      Gonadotropin preparations -&#xD;
&#xD;
        1. As HP-HMG we will use Menopur© (menotropins for injection, FERRING) which contains equal&#xD;
           amount of FSH &amp; LH.&#xD;
&#xD;
        2. As the recombinant preparation we will use Pergoveris© (follitropin alfa/lutropin alfa,&#xD;
           MERCK SERONO) which contains 150 units of FSH + 75 units of LH and Luveris© (lutropin&#xD;
           alfa, MERCK SERONO) which is LH only preparation.&#xD;
&#xD;
      The patients - The study population will consist of all consecutive eligible patients&#xD;
      attending the IVF unit of our department for treatment of infertility. The study required no&#xD;
      modification of our routine, flexible, multi-dose GnRH antagonist protocol.&#xD;
&#xD;
      Briefly, after the presence of quiescent ovaries on transvaginal ultrasound and low serum E2&#xD;
      level were confirmed on day 2/3 of menstruation, recombinant FSH - Gonal-F© (follitropin&#xD;
      alfa; MERCK SERONO) will be administered subcutaneously at a starting dose of 150-300 IU,&#xD;
      depending on patient's age and/or ovarian responsiveness in previous cycles. The gonadotropin&#xD;
      dosage will be adjusted individually according to serum E2 levels and vaginal ultrasound&#xD;
      measurements of follicular diameter, obtained every one or two days. LH will be added to the&#xD;
      protocol as urinary preparation Menopur© (menotropins for injection, FERRING) or as&#xD;
      recombinant preparations - Pergoveris© (follitropin alfa/lutropin alfa, MERCK SERONO) with or&#xD;
      without Luveris© (lutropin alfa, MERCK SERONO). GnRH-antagonist - Cetrotide© (cetrorelix,&#xD;
      MERCK SERONO), 0.25 mg daily subcutaneously, will be added when the leading follicle reached&#xD;
      14-16 mm diameter, and will be continued until the day of ovulation triggering. When at least&#xD;
      three mature (&gt;17 mm) follicles will be obtained, patients will receive an injection of&#xD;
      either Ovitrelle© 250 mcg (Choriogonadotropin alfa, MERCK SERONO) or GnRH-agonist -&#xD;
      Decapeptyl© 0.2 mg (Triptorelin acetate, FERRING).&#xD;
&#xD;
      In summary, for the purpose of the study, in addition to the routine monitoring during the&#xD;
      COH cycle, blood samples will be drawn to determine the hormonal profile (E2, progesterone),&#xD;
      levels of serum androgens, namely, testosterone, androstendione, 17-OH progesterone and LH&#xD;
      and FSH: (1) day 1-3 of menstruation (Day-S); (2) day of or prior to hCG administration&#xD;
      (Day-hCG); and (3) day of ovum pick-up (Day-OPU).&#xD;
&#xD;
      Moreover, pooled follicular fluid will be collected after oocytes retrieval (fluid destined&#xD;
      to be discarded) and will be examined for hormonal profile (FSH, LH, progesterone, estradiol,&#xD;
      testosterone, androstendione, 17-OH progesterone).&#xD;
&#xD;
      To note - participation in this study WILL NOT change the COH treatment.&#xD;
&#xD;
      Statistics - The chi-squared test and analysis of variance (ANOVA) will be applied to detect&#xD;
      statistically significant differences among the groups with regard to proportions or means. A&#xD;
      two-sided P &lt; 0.05 was considered statistically significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">January 2020</completion_date>
  <primary_completion_date type="Anticipated">January 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum hormonal profile</measure>
    <time_frame>(1) day 1-3 of menstruation (Day-S); (2) day of or prior to hCG administration (Day-hCG); and (3) day of ovum pick-up (Day-OPU).</time_frame>
    <description>Hormonal profile = FSH, LH, progesterone, estradiol, testosterone, androstendione, 17-OH progesterone</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Follicular fluid hormonal profile</measure>
    <time_frame>Ovum pick up day</time_frame>
    <description>Hormonal profile = FSH, LH, progesterone, estradiol, testosterone, androstendione, 17-OH progesterone</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Implantation rate</measure>
    <time_frame>About three weeks after embryo transfer</time_frame>
    <description>Number of gestational sacs on US exam / number of retrieved embryos</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical pregnancy</measure>
    <time_frame>About three weeks after embryo transfer</time_frame>
    <description>Number of cases with gestational sac per US exam / cases of embryo transfer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemical pregnancy</measure>
    <time_frame>About two weeks after embryo tranfer</time_frame>
    <description>Positive BHCG test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ongoing pregnancy</measure>
    <time_frame>10-12 weeks after embryo tranfer</time_frame>
    <description>Number of viable pregnancies at about 10-12 weeks of gestation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Live birth rate</measure>
    <time_frame>Until about 40 weeks after embryo transfer</time_frame>
    <description>Number of pregnancies ended in a live birth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of follicles</measure>
    <time_frame>During stimulation - one-two dayes before ovum pick-up</time_frame>
    <description>Larger than 14 mm follicles per US</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of oocytes retrieved</measure>
    <time_frame>1 day right after ovarian pick-up</time_frame>
    <description>Number of oocytes retrieved during ovarian pick-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of embryos</measure>
    <time_frame>About 3 days after OPU (ovum pick-up)</time_frame>
    <description>Number of developing embryos in the laboratory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of top quality embryos</measure>
    <time_frame>3 days after OPU</time_frame>
    <description>The number of day 3 embryos with 7-8 cells with less than 15% fragmentation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Infertility, Female</condition>
  <arm_group>
    <arm_group_label>Recombinant preparations</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>HP-HMG</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Highly purified human menopausal gonadotropin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>recombinant gonadotropins</intervention_name>
    <arm_group_label>Recombinant preparations</arm_group_label>
    <other_name>Pergoveris &amp; Luveris</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HP-HMG</intervention_name>
    <arm_group_label>HP-HMG</arm_group_label>
    <other_name>Menopur</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infertile women between 20-40 years of age&#xD;
&#xD;
          -  BMI 19-35&#xD;
&#xD;
          -  undergoing their 1-4 IVF cycle&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suspected PCOS&#xD;
&#xD;
          -  History of OHSS&#xD;
&#xD;
          -  Patients who had a chronic illness or were receiving chronic medical treatment&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Eran Zilberberg, MD</last_name>
    <phone>+97235302882</phone>
  </overall_contact>
  <reference>
    <citation>Andersen AN, Devroey P, Arce JC. Clinical outcome following stimulation with highly purified hMG or recombinant FSH in patients undergoing IVF: a randomized assessor-blind controlled trial. Hum Reprod. 2006 Dec;21(12):3217-27. doi: 10.1093/humrep/del284. Epub 2006 Jul 27.</citation>
    <PMID>16873892</PMID>
  </reference>
  <reference>
    <citation>Devroey P, Pellicer A, Nyboe Andersen A, Arce JC; Menopur in GnRH Antagonist Cycles with Single Embryo Transfer Trial Group. A randomized assessor-blind trial comparing highly purified hMG and recombinant FSH in a GnRH antagonist cycle with compulsory single-blastocyst transfer. Fertil Steril. 2012 Mar;97(3):561-71. doi: 10.1016/j.fertnstert.2011.12.016. Epub 2012 Jan 13.</citation>
    <PMID>22244781</PMID>
  </reference>
  <reference>
    <citation>Van Wely M, Westergaard LG, Bossuyt PM, Van der Veen F. Human menopausal gonadotropin versus recombinant follicle stimulation hormone for ovarian stimulation in assisted reproductive cycles. Cochrane Database Syst Rev. 2003;(1):CD003973. doi: 10.1002/14651858.CD003973.</citation>
    <PMID>12535497</PMID>
  </reference>
  <reference>
    <citation>Requena A, Cruz M, Ruiz FJ, Garcia-Velasco JA. Endocrine profile following stimulation with recombinant follicle stimulating hormone and luteinizing hormone versus highly purified human menopausal gonadotropin. Reprod Biol Endocrinol. 2014 Jan 29;12:10. doi: 10.1186/1477-7827-12-10.</citation>
    <PMID>24476504</PMID>
  </reference>
  <reference>
    <citation>Revelli A, Pettinau G, Basso G, Carosso A, Ferrero A, Dallan C, Canosa S, Gennarelli G, Guidetti D, Filippini C, Benedetto C. Controlled Ovarian Stimulation with recombinant-FSH plus recombinant-LH vs. human Menopausal Gonadotropin based on the number of retrieved oocytes: results from a routine clinical practice in a real-life population. Reprod Biol Endocrinol. 2015 Jul 25;13:77. doi: 10.1186/s12958-015-0080-6.</citation>
    <PMID>26209525</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 11, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>December 18, 2016</last_update_submitted>
  <last_update_submitted_qc>December 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sheba Medical Center</investigator_affiliation>
    <investigator_full_name>Dr. Eran Zilberberg</investigator_full_name>
    <investigator_title>Senior physician, Infertility &amp; IVF Unit, Department of Obstetrics &amp; Gynecology</investigator_title>
  </responsible_party>
  <keyword>IVF</keyword>
  <keyword>Ovarian stimulation</keyword>
  <keyword>Androgenic profile</keyword>
  <keyword>Follicular fluid</keyword>
  <keyword>Recombinant gonadotropins</keyword>
  <keyword>human menopausal gonadotropin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Infertility, Female</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Menotropins</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02992808
org study id: SHEBA-16-3516-EZ-CTIL
nct id: NCT02992808
lead sponsor: 
has dmc: No
In this study the investigators will try to discover whether there is a difference for any of
      the stimulation preparations - recombinant FSH + recombinant LH (pergoveris & luveris) vs.
      human menopausal gonadotropin (menopur) during GnRH-antagonist cycles in the meaning of
      androgenic hormones profile. The study question is whether using recombinant LH will result
      in different follicular hormonal milieu, serum endocrine profile or IVF outcomes than using
      highly purified urinary gonadotropins with hCG mimicking LH activity.
ABSTRACT:

      The optimal controlled ovarian stimulation (COH) protocol is yet to be decided and most
      probably there is no right protocol that is optimal for all patients.

      The role of luteinizing hormone (LH) administration during controlled ovarian stimulation
      (COH) is widely debated in the current medical literature.

      Until recently the only source for exogenous LH activity was HMG preparations, however, in
      the past few years an advancement in the field of recombinant technology resulted in
      recombinant preparations of LH. In contrast to LH activity in HMG which is mainly due to hCG
      rather than from LH, using r-LH provides true, consistent and precise LH activity.

      In the past years few papers were published about the difference between recombinant follicle
      stimulating hormone (r-FSH) and menotropins but there is still a need for researching the
      different effects of gonadotropins preparations and in particular the effect of LH
      administration during COH in the manner of follicular endocrine characteristics, embryo
      quality and pregnancy outcomes.

      In the present study the investigators aim to elucidate whether there is a difference for any
      of the stimulation preparations - recombinant FSH + recombinant LH (pergoveris & luveris) vs.
      human menopausal gonadotropin (menopur) during GnRH-antagonist cycles. The study question is
      whether using recombinant LH will result in different follicular hormonal milieu, serum
      endocrine profile or IVF outcomes than using highly purified urinary gonadotropins with hCG
      mimicking LH activity.

      In the relevant medical literature there is one prospective study dealing with the same
      question, but, during long-GnRH-agonist cycles. In the aforementioned paper there were no
      significant differences between the two stimulation preparations.

      MATERIALS & METHODS:

      Study design - A non-intervention observational trial. Primary endpoint - Serum & follicular
      fluid hormonal profile during COH (FSH, LH, progesterone, estradiol, testosterone,
      androstendione, 17-OH progesterone) Secondary endpoints - Implantation rate, clinical
      pregnancy, # of follicles, # of oocytes, # of embryos, top quality embryos.

      Study sample - 100 patients undergoing COH for IVF using the GnRH-antagonist protocol
      Inclusion criteria - 20-40 years old IVF patients, BMI 19-35 undergoing their 1-4 IVF cycle.

      Exclusion criteria - Suspected PCOS, history of OHSS, Patients who had a chronic illness or
      were receiving chronic medical treatment will be excluded.

      Gonadotropin preparations -

        1. As HP-HMG we will use Menopur© (menotropins for injection, FERRING) which contains equal
           amount of FSH & LH.

        2. As the recombinant preparation we will use Pergoveris© (follitropin alfa/lutropin alfa,
           MERCK SERONO) which contains 150 units of FSH + 75 units of LH and Luveris© (lutropin
           alfa, MERCK SERONO) which is LH only preparation.

      The patients - The study population will consist of all consecutive eligible patients
      attending the IVF unit of our department for treatment of infertility. The study required no
      modification of our routine, flexible, multi-dose GnRH antagonist protocol.

      Briefly, after the presence of quiescent ovaries on transvaginal ultrasound and low serum E2
      level were confirmed on day 2/3 of menstruation, recombinant FSH - Gonal-F© (follitropin
      alfa; MERCK SERONO) will be administered subcutaneously at a starting dose of 150-300 IU,
      depending on patient's age and/or ovarian responsiveness in previous cycles. The gonadotropin
      dosage will be adjusted individually according to serum E2 levels and vaginal ultrasound
      measurements of follicular diameter, obtained every one or two days. LH will be added to the
      protocol as urinary preparation Menopur© (menotropins for injection, FERRING) or as
      recombinant preparations - Pergoveris© (follitropin alfa/lutropin alfa, MERCK SERONO) with or
      without Luveris© (lutropin alfa, MERCK SERONO). GnRH-antagonist - Cetrotide© (cetrorelix,
      MERCK SERONO), 0.25 mg daily subcutaneously, will be added when the leading follicle reached
      14-16 mm diameter, and will be continued until the day of ovulation triggering. When at least
      three mature (>17 mm) follicles will be obtained, patients will receive an injection of
      either Ovitrelle© 250 mcg (Choriogonadotropin alfa, MERCK SERONO) or GnRH-agonist -
      Decapeptyl© 0.2 mg (Triptorelin acetate, FERRING).

      In summary, for the purpose of the study, in addition to the routine monitoring during the
      COH cycle, blood samples will be drawn to determine the hormonal profile (E2, progesterone),
      levels of serum androgens, namely, testosterone, androstendione, 17-OH progesterone and LH
      and FSH: (1) day 1-3 of menstruation (Day-S); (2) day of or prior to hCG administration
      (Day-hCG); and (3) day of ovum pick-up (Day-OPU).

      Moreover, pooled follicular fluid will be collected after oocytes retrieval (fluid destined
      to be discarded) and will be examined for hormonal profile (FSH, LH, progesterone, estradiol,
      testosterone, androstendione, 17-OH progesterone).

      To note - participation in this study WILL NOT change the COH treatment.

      Statistics - The chi-squared test and analysis of variance (ANOVA) will be applied to detect
      statistically significant differences among the groups with regard to proportions or means. A
      two-sided P < 0.05 was considered statistically significant.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Serum hormonal profile
time frame: (1) day 1-3 of menstruation (Day-S); (2) day of or prior to hCG administration (Day-hCG); and (3) day of ovum pick-up (Day-OPU).
description: Hormonal profile = FSH, LH, progesterone, estradiol, testosterone, androstendione, 17-OH progesterone
measure: Follicular fluid hormonal profile
time frame: Ovum pick up day
description: Hormonal profile = FSH, LH, progesterone, estradiol, testosterone, androstendione, 17-OH progesterone
measure: Implantation rate
time frame: About three weeks after embryo transfer
description: Number of gestational sacs on US exam / number of retrieved embryos
measure: Clinical pregnancy
time frame: About three weeks after embryo transfer
description: Number of cases with gestational sac per US exam / cases of embryo transfer
measure: Biochemical pregnancy
time frame: About two weeks after embryo tranfer
description: Positive BHCG test
measure: Ongoing pregnancy
time frame: 10-12 weeks after embryo tranfer
description: Number of viable pregnancies at about 10-12 weeks of gestation
measure: Live birth rate
time frame: Until about 40 weeks after embryo transfer
description: Number of pregnancies ended in a live birth
measure: Number of follicles
time frame: During stimulation - one-two dayes before ovum pick-up
description: Larger than 14 mm follicles per US
measure: Number of oocytes retrieved
time frame: 1 day right after ovarian pick-up
description: Number of oocytes retrieved during ovarian pick-up
measure: Number of embryos
time frame: About 3 days after OPU (ovum pick-up)
description: Number of developing embryos in the laboratory
measure: Number of top quality embryos
time frame: 3 days after OPU
description: The number of day 3 embryos with 7-8 cells with less than 15% fragmentation
arm group label: Recombinant preparations
arm group type: Active Comparator
arm group label: HP-HMG
arm group type: Active Comparator
description: Highly purified human menopausal gonadotropin
intervention type: Drug
intervention name: recombinant gonadotropins
arm group label: Recombinant preparations
other name: Pergoveris & Luveris
intervention type: Drug
intervention name: HP-HMG
arm group label: HP-HMG
other name: Menopur
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eran Zilberberg, MD
phone: +97235302882
citation: Andersen AN, Devroey P, Arce JC. Clinical outcome following stimulation with highly purified hMG or recombinant FSH in patients undergoing IVF: a randomized assessor-blind controlled trial. Hum Reprod. 2006 Dec;21(12):3217-27. doi: 10.1093/humrep/del284. Epub 2006 Jul 27.
PMID: 16873892
citation: Devroey P, Pellicer A, Nyboe Andersen A, Arce JC; Menopur in GnRH Antagonist Cycles with Single Embryo Transfer Trial Group. A randomized assessor-blind trial comparing highly purified hMG and recombinant FSH in a GnRH antagonist cycle with compulsory single-blastocyst transfer. Fertil Steril. 2012 Mar;97(3):561-71. doi: 10.1016/j.fertnstert.2011.12.016. Epub 2012 Jan 13.
PMID: 22244781
citation: Van Wely M, Westergaard LG, Bossuyt PM, Van der Veen F. Human menopausal gonadotropin versus recombinant follicle stimulation hormone for ovarian stimulation in assisted reproductive cycles. Cochrane Database Syst Rev. 2003;(1):CD003973. doi: 10.1002/14651858.CD003973.
PMID: 12535497
citation: Requena A, Cruz M, Ruiz FJ, Garcia-Velasco JA. Endocrine profile following stimulation with recombinant follicle stimulating hormone and luteinizing hormone versus highly purified human menopausal gonadotropin. Reprod Biol Endocrinol. 2014 Jan 29;12:10. doi: 10.1186/1477-7827-12-10.
PMID: 24476504
citation: Revelli A, Pettinau G, Basso G, Carosso A, Ferrero A, Dallan C, Canosa S, Gennarelli G, Guidetti D, Filippini C, Benedetto C. Controlled Ovarian Stimulation with recombinant-FSH plus recombinant-LH vs. human Menopausal Gonadotropin based on the number of retrieved oocytes: results from a routine clinical practice in a real-life population. Reprod Biol Endocrinol. 2015 Jul 25;13:77. doi: 10.1186/s12958-015-0080-6.
PMID: 26209525
responsible party type: Principal Investigator
investigator affiliation: Sheba Medical Center
investigator full name: Dr. Eran Zilberberg
investigator title: Senior physician, Infertility & IVF Unit, Department of Obstetrics & Gynecology
mesh term: Infertility
mesh term: Infertility, Female
mesh term: Menotropins
sharing ipd: No