<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/NCT04447677</url>
  </required_header>
  <id_info>
    <org_study_id>25138</org_study_id>
    <nct_id>NCT04447677</nct_id>
  </id_info>
  <brief_title>Oocyte Retrieval Progesterone Levels and IVF</brief_title>
  <official_title>Correlation of Progesterone Levels on the Day of Oocyte Retrieval With Basal Hormonal Status and the Outcome of in Vitro Fertilization in Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Belgrade</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Belgrade</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>
      Objective: To assess whether basal hormonal level can predict the elevation of P4 on the day&#xD;
      of oocyte retrieval, as well as to examine the impact of P4 elevation on the day of oocyte&#xD;
      retrieval on the outcome of assisted reproduction.&#xD;
&#xD;
      Design: Prospective cohort study Setting: Department of In Vitro Fertilization, Gynecology&#xD;
      and Obstetrics Institute, Clinical Center of Serbia Patient(s): One hundred sixty four&#xD;
      patients enrolled in the ART procedure Main Outcome Measure(s): Pregnancies, miscarriages,&#xD;
      biochemical pregnancies and deliveries&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective clinical trial was conducted at the Clinic for Gynecology and Obstetrics&#xD;
      Clinical Center of Serbia from January 1st to December 31st 2015. The study included 164&#xD;
      patients enrolled in the ART procedure at the Clinic.&#xD;
&#xD;
      Basal hormonal status - serum levels of estradiol (E2 - pg/ml), progesterone (P4 - ng/ml),&#xD;
      follicle-stimulating hormone (FSH - mIU/ml), luteinizing hormone (LH - mIU/ml) and&#xD;
      anti-Mullerian hormone (AMH - ng/l) were measured on the 2ndor 3rd cycle day before&#xD;
      stimulation commencement. During COS levels of estradiol were determined, while levels of&#xD;
      progesterone were determined on the day of oocyte retrieval i.e. aspiration. Blood samples&#xD;
      were taken by Vacutainer tubes (BD Vacutainer Systems) and centrifuged according to the&#xD;
      manufacturer's instructions for the preparation of the serum samples. AMH value (Gen II ELISA&#xD;
      ref. No. A79765; Beckman Coulter) in serum was measured by ELISA (enzyme-linked immunosorbent&#xD;
      assay), 1 ng / ml). FSH, LH, estradiol, and progesterone were analyzed by chemiluminescent&#xD;
      immunoassay (Access 2 immunoassay system, Beckman Coulter).&#xD;
&#xD;
      The main outcome measures were the procedure success as well as the pregnancy outcome.&#xD;
      Pregnancy was confirmed by a positive finding of serum β-hCG (&gt;25 MIU/ml) 14 days after&#xD;
      embryo transfer. Clinical pregnancies were confirmed by transvaginal ultrasound findings of a&#xD;
      gestational sac with a vital embryo at the 6th gestational week.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Actual">December 31, 2015</completion_date>
  <primary_completion_date type="Actual">December 31, 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Outcome of Ivf procedure</measure>
    <time_frame>12 months</time_frame>
    <description>Outcome of ivf procedure can be positive and devided in pregnancies, miscariages or biochemical pregnancies or can be negative outcome -failire of procedure</description>
  </primary_outcome>
  <enrollment type="Actual">164</enrollment>
  <condition>Hormone Disturbance</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study evaluated 164 patients undergoing ART procedure - oocyte retrieval and embryo&#xD;
        transfer in our Clinic. Patients in average had 34.66 ± 3.39 years, mean BMI was 22.23 ±&#xD;
        2.65, and their infertility mostly lasted for 4.86 ± 2.61 years (range 1 to 17 years).&#xD;
&#xD;
        The mean P4 values on OR day were 1.26 ± 0.46 ng/ml in group P4 &lt;2ng/ml, while in the group&#xD;
        of patients with P4 values ≥2ng/ml, the average P4 was 3.74 ± 1.62 ng/ml.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 to 40 years of age&#xD;
&#xD;
          -  BMI of 18 to 30 kg/m2&#xD;
&#xD;
          -  regular menstrual cycles from 25 to 32 days&#xD;
&#xD;
          -  established diagnosis of infertility.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less then 18 or more then 40 years old&#xD;
&#xD;
          -  BMI less then 18 or more then 30 kg/m2&#xD;
&#xD;
          -  irregular menstrual cycles&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>June 23, 2020</last_update_submitted>
  <last_update_submitted_qc>June 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Belgrade</investigator_affiliation>
    <investigator_full_name>Lidija Tulic</investigator_full_name>
    <investigator_title>Assistent Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endocrine System Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04447677
org study id: 25138
nct id: NCT04447677
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Objective: To assess whether basal hormonal level can predict the elevation of P4 on the day
      of oocyte retrieval, as well as to examine the impact of P4 elevation on the day of oocyte
      retrieval on the outcome of assisted reproduction.

      Design: Prospective cohort study Setting: Department of In Vitro Fertilization, Gynecology
      and Obstetrics Institute, Clinical Center of Serbia Patient(s): One hundred sixty four
      patients enrolled in the ART procedure Main Outcome Measure(s): Pregnancies, miscarriages,
      biochemical pregnancies and deliveries
A prospective clinical trial was conducted at the Clinic for Gynecology and Obstetrics
      Clinical Center of Serbia from January 1st to December 31st 2015. The study included 164
      patients enrolled in the ART procedure at the Clinic.

      Basal hormonal status - serum levels of estradiol (E2 - pg/ml), progesterone (P4 - ng/ml),
      follicle-stimulating hormone (FSH - mIU/ml), luteinizing hormone (LH - mIU/ml) and
      anti-Mullerian hormone (AMH - ng/l) were measured on the 2ndor 3rd cycle day before
      stimulation commencement. During COS levels of estradiol were determined, while levels of
      progesterone were determined on the day of oocyte retrieval i.e. aspiration. Blood samples
      were taken by Vacutainer tubes (BD Vacutainer Systems) and centrifuged according to the
      manufacturer's instructions for the preparation of the serum samples. AMH value (Gen II ELISA
      ref. No. A79765; Beckman Coulter) in serum was measured by ELISA (enzyme-linked immunosorbent
      assay), 1 ng / ml). FSH, LH, estradiol, and progesterone were analyzed by chemiluminescent
      immunoassay (Access 2 immunoassay system, Beckman Coulter).

      The main outcome measures were the procedure success as well as the pregnancy outcome.
      Pregnancy was confirmed by a positive finding of serum β-hCG (>25 MIU/ml) 14 days after
      embryo transfer. Clinical pregnancies were confirmed by transvaginal ultrasound findings of a
      gestational sac with a vital embryo at the 6th gestational week.
observational model: Cohort
time perspective: Prospective
measure: Outcome of Ivf procedure
time frame: 12 months
description: Outcome of ivf procedure can be positive and devided in pregnancies, miscariages or biochemical pregnancies or can be negative outcome -failire of procedure
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Belgrade
investigator full name: Lidija Tulic
investigator title: Assistent Professor
mesh term: Endocrine System Diseases
sharing ipd: Undecided