<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/NCT04458454</url>
  </required_header>
  <id_info>
    <org_study_id>DOOttResearch</org_study_id>
    <nct_id>NCT04458454</nct_id>
  </id_info>
  <brief_title>&quot;Study of the Effects of Serum and Follicular Fluid Relaxin Levels on Ovarian Function in IVF Cycles&quot;</brief_title>
  <acronym>&quot;Relaxifert&quot;</acronym>
  <official_title>&quot;Study of the Effects of Serum and Follicular Fluid Relaxin Levels on Ovarian Function in IVF Cycles as a Part of the Project &quot;Relaxifert&quot; &quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study evaluated the effect of serum relaxin and follicular fluid levels on the number and&#xD;
      quality of oocytes, fertilization, the number and quality of the embryos in IVF protocols.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Relaxin is one of the promising indicators of oocyte quality and prognosis of the&#xD;
      effectiveness of invitro fertilization protocols. The hormone plays an important role in the&#xD;
      processes of folliculogenesis, growth and maturation of oocytes, development of embryos,&#xD;
      implantation processes, pregnancy and childbirth. A pilot study was conducted on a group of&#xD;
      patients undergoing infertility treatment using assisted reproductive technologies in the&#xD;
      superovulation stimulation protocol using gonadotropin releasing hormone antagonists. Blood&#xD;
      and follicular fluid samples were obtained on the day of transvaginal follicular puncture.&#xD;
      The results allow us to consider the hormone relaxin as a promising predictor of the result&#xD;
      of ovarian stimulation, the effectiveness of fertilization in IVF cycles.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2, 2019</start_date>
  <completion_date type="Actual">February 20, 2020</completion_date>
  <primary_completion_date type="Actual">February 20, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between the relaxin values in follicular fluid and the number of oocytes obtained</measure>
    <time_frame>10-14 days from the start of stimulation in the IVF protocol ( the day of transvaginal follicular puncture)</time_frame>
    <description>The level of relaxin in follicular fluid was estimated using an ELISA Kit for Relaxin 2. The range of detectable concentrations was 3.1-500 pg / ml. Higher relaxin concentrations in follicular fluid are associated with a higher number of oocytes obtained.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between the relaxin levels in follicular fluid and oocyte fertilization efficiency</measure>
    <time_frame>10-14 days from the start of stimulation in the IVF protocol for relaxin. The first day after transvaginal follicular puncture for evaluation oocyte fertilization efficiency.</time_frame>
    <description>The level of relaxin in follicular fluid was estimated using an ELISA Kit for Relaxin 2. The range of detected concentrations was 3.1-500 pg / ml. In course of standard IVF technique the fertilization efficacy was evaluated as a ratio of double pro-nucleus zygote on the 1st day of development to obtained oocyte-cumulus complexes number. In course of ICSI the efficacy was estimated as ratio of double pro-nucleus zygote on the 1st day of development to oocyte number on MII stage on puncture day. Higher concentrations of follicular fluid relaxin are associated with a decrease efficacy of oocyte fertilization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the relaxin levels in follicular fluid and age</measure>
    <time_frame>10-14 days from the start of stimulation in the IVF protocol</time_frame>
    <description>The method of relaxin determining in follicular fluid and the range of determined concentrations are described previously. With increasing age, a decrease in the concentration of relaxin in the follicular fluid was noted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the relaxin levels in follicular fluid and BMI</measure>
    <time_frame>10-14 days from the start of stimulation in the IVF protocol</time_frame>
    <description>The method of relaxin determining in follicular fluid and the range of determined concentrations are described previously. With increasing of BMI, a decrease in the concentration of relaxin in the follicular fluid was noted.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">11</enrollment>
  <condition>Infertility</condition>
  <condition>Reproductive Techniques, Assisted</condition>
  <condition>Oocyte Maturation</condition>
  <arm_group>
    <arm_group_label>Examination of relaxin levels</arm_group_label>
    <description>This is a pilot study of 1 group of patients. The analysis of relaxin levels in serum and follicular fluid obtained on the day of puncture of the follicles in patients undergoing treatment in the IVF protocol is carried out.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Relaxin ELISA Kit</intervention_name>
    <description>Ovarian stimulation was carried out from day 3 of the menstrual cycle using a fixed protocol, with recombinant (Gonal-F, Pergoveris) or human menopausal gonadotropins (Meriofert), GnRH antagonist (ganirelix 0.25 mg). A recombinant human chorionic gonadotropin Ovitrel 250 μg or a GnRH agonist, Diferelin 0.2 mg, was used as an ovulation trigger.</description>
    <arm_group_label>Examination of relaxin levels</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study included patients undergoing treatment in the Department of Assisted Reproductive&#xD;
        Technologies of The Research Institute of Obstetrics, Gynecology and Reproductology named&#xD;
        after D.O. Ott, Saint Petersburg, Russia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Clinical diagnosis of Primary or Secondary infertility&#xD;
&#xD;
          2. Must be signed the voluntary informed consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The presence of IVF contra-indications.&#xD;
&#xD;
          2. Clinical diagnosis of large uterine fibroids.&#xD;
&#xD;
          3. BMI&gt; 35 kg / m2&#xD;
&#xD;
          4. Morphological diagnosis of endometrial hyperplastic processes&#xD;
&#xD;
          5. Clinical diagnosis of infectious.&#xD;
&#xD;
          6. Clinical diagnosis of systemic autoimmune diseases.&#xD;
&#xD;
          7. Insulin dependent diabetes&#xD;
&#xD;
          8. Oncological diseases&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>female</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>43 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olesya N Bespalova, MD, DSci</last_name>
    <role>Principal Investigator</role>
    <affiliation>D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>DOOttResearch</name>
      <address>
        <city>Saint Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology</investigator_affiliation>
    <investigator_full_name>Olesya Nikolaevna Bespalova</investigator_full_name>
    <investigator_title>Olesya Nikolaevna Bespalova, MD, PhD, DSci (Medicine), Deputy Director for Research. The Research Institute of Obstetrics, Gynecology and Reproductology named after D.O. Ott</investigator_title>
  </responsible_party>
  <keyword>Infertility</keyword>
  <keyword>Relaxin</keyword>
  <keyword>Oocytes</keyword>
  <keyword>Embryo quality</keyword>
  <keyword>IVF</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methocarbamol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>For this study, do not see the need to publish these data.</ipd_description>
  </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/NCT04458454
org study id: DOOttResearch
nct id: NCT04458454
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study evaluated the effect of serum relaxin and follicular fluid levels on the number and
      quality of oocytes, fertilization, the number and quality of the embryos in IVF protocols.
Relaxin is one of the promising indicators of oocyte quality and prognosis of the
      effectiveness of invitro fertilization protocols. The hormone plays an important role in the
      processes of folliculogenesis, growth and maturation of oocytes, development of embryos,
      implantation processes, pregnancy and childbirth. A pilot study was conducted on a group of
      patients undergoing infertility treatment using assisted reproductive technologies in the
      superovulation stimulation protocol using gonadotropin releasing hormone antagonists. Blood
      and follicular fluid samples were obtained on the day of transvaginal follicular puncture.
      The results allow us to consider the hormone relaxin as a promising predictor of the result
      of ovarian stimulation, the effectiveness of fertilization in IVF cycles.
observational model: Cohort
time perspective: Prospective
measure: Correlation between the relaxin values in follicular fluid and the number of oocytes obtained
time frame: 10-14 days from the start of stimulation in the IVF protocol ( the day of transvaginal follicular puncture)
description: The level of relaxin in follicular fluid was estimated using an ELISA Kit for Relaxin 2. The range of detectable concentrations was 3.1-500 pg / ml. Higher relaxin concentrations in follicular fluid are associated with a higher number of oocytes obtained.
measure: Correlation between the relaxin levels in follicular fluid and oocyte fertilization efficiency
time frame: 10-14 days from the start of stimulation in the IVF protocol for relaxin. The first day after transvaginal follicular puncture for evaluation oocyte fertilization efficiency.
description: The level of relaxin in follicular fluid was estimated using an ELISA Kit for Relaxin 2. The range of detected concentrations was 3.1-500 pg / ml. In course of standard IVF technique the fertilization efficacy was evaluated as a ratio of double pro-nucleus zygote on the 1st day of development to obtained oocyte-cumulus complexes number. In course of ICSI the efficacy was estimated as ratio of double pro-nucleus zygote on the 1st day of development to oocyte number on MII stage on puncture day. Higher concentrations of follicular fluid relaxin are associated with a decrease efficacy of oocyte fertilization
measure: Correlation between the relaxin levels in follicular fluid and age
time frame: 10-14 days from the start of stimulation in the IVF protocol
description: The method of relaxin determining in follicular fluid and the range of determined concentrations are described previously. With increasing age, a decrease in the concentration of relaxin in the follicular fluid was noted.
measure: Correlation between the relaxin levels in follicular fluid and BMI
time frame: 10-14 days from the start of stimulation in the IVF protocol
description: The method of relaxin determining in follicular fluid and the range of determined concentrations are described previously. With increasing of BMI, a decrease in the concentration of relaxin in the follicular fluid was noted.
arm group label: Examination of relaxin levels
description: This is a pilot study of 1 group of patients. The analysis of relaxin levels in serum and follicular fluid obtained on the day of puncture of the follicles in patients undergoing treatment in the IVF protocol is carried out.
intervention type: Diagnostic Test
intervention name: Relaxin ELISA Kit
description: Ovarian stimulation was carried out from day 3 of the menstrual cycle using a fixed protocol, with recombinant (Gonal-F, Pergoveris) or human menopausal gonadotropins (Meriofert), GnRH antagonist (ganirelix 0.25 mg). A recombinant human chorionic gonadotropin Ovitrel 250 μg or a GnRH agonist, Diferelin 0.2 mg, was used as an ovulation trigger.
arm group label: Examination of relaxin levels
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: female
minimum age: 20 Years
maximum age: 43 Years
healthy volunteers: No
last name: Olesya N Bespalova, MD, DSci
role: Principal Investigator
affiliation: D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology
facility: 
country: Russian Federation
responsible party type: Principal Investigator
investigator affiliation: D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology
investigator full name: Olesya Nikolaevna Bespalova
investigator title: Olesya Nikolaevna Bespalova, MD, PhD, DSci (Medicine), Deputy Director for Research. The Research Institute of Obstetrics, Gynecology and Reproductology named after D.O. Ott
mesh term: Infertility
mesh term: Methocarbamol
sharing ipd: No
ipd description: For this study, do not see the need to publish these data.