xml: <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/NCT05969795</url>
    </required_header>
    <id_info>
      <org_study_id>2306-ABU-009-BL</org_study_id>
      <nct_id>NCT05969795</nct_id>
    </id_info>
    <brief_title>Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support</brief_title>
    <official_title>Comparison of Live Birth Rate (&gt; 24 Weeks) in Natural Cycle (NC) Single Euploid Frozen Embryo Transfers (FET) With Versus Without Luteal Phase Support (LPS)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>ART Fertility Clinics LLC</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>ART Fertility Clinics LLC</source>
    <oversight_info>
      <has_dmc>Yes</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>
        To evaluate whether single euploid embryo transfer in NC without routinely administered LPS&#xD;
        is non-inferior to NC with routinely administered LPS.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In case the study will show that the live birth rate in single euploid NC frozen embryo&#xD;
        transfer cycles without LPS is not inferior to NC cycles with LPS, treatment can be&#xD;
        simplified, and participants comfort can be increased.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2024</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Implantation rate</measure>
      <time_frame>2 months</time_frame>
      <description>Number of embryos which have produced ultrasonographic evidence of an intrauterine gestational sac per the total number of embryos transferred into the uterine cavity (Zegers-Hochschild et al., 2009).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinical pregnancy rate</measure>
      <time_frame>2 months</time_frame>
      <description>hCG &gt; 15 Iu/ml and ultrasound confirmation of a gestational sac</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Live birth rate</measure>
      <time_frame>41 weeks</time_frame>
      <description>Number of deliveries that resulted in a live born neonate, expressed per 100 embryo transfers (Zegers-Hochschild et al., 2009)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Serum P4 levels on ET day</measure>
      <time_frame>1 day</time_frame>
      <description>Progesterone level on the day of embryo transfer</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Serum E2 and P4 levels on day 5 or 6 after ET procedure</measure>
      <time_frame>6 days</time_frame>
      <description>Estradiol and Progesterone levels on day 5 or 6 after embryo transfer</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Serum E2 and P4 levels on day 10 after ET procedure</measure>
      <time_frame>10 days</time_frame>
      <description>Estradiol and Progesterone levels on day 10 after embryo transfer</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">342</enrollment>
    <condition>Pregnancy Related</condition>
    <condition>Infertility, Female</condition>
    <arm_group>
      <arm_group_label>Study Group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Intermittent ultrasound scans to monitor follicular growth and serial measurements of serum LH, E2 and P4 levels throughout the cycle to determine ovulation. Embryo transfer (ET) will be scheduled on the fifth day after ovulation. Blood for P4 measurement will be drawn upon admission to the clinic for the ET procedure. P4 will be measured on day 5 or day 6 after the ET procedure and together with the hCG 10 days after ET procedure.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Intermittent ultrasound scans to monitor follicular growth and serial measurements of serum LH, E2 and P4 levels throughout the cycle to determine ovulation. Embryo transfer (ET) will be scheduled on the fifth day after ovulation. Administer on FET day 200 mg of P4 and increase to 300 mg/day from the day after the ET onwards until the pregnancy test. Blood for P4 measurement will be drawn before starting LPS in form of vaginal progesterone. P4 will be measured on day 5 or day 6 after the ET procedure and together with the hCG 10 days after ET procedure. In case of an implantation, vaginal P4 will be continued until 7 weeks of pregnancy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Transvaginal ultrasound</intervention_name>
      <description>Intermittent transvaginal ultrasound throughout the cycle to monitor follicular growth</description>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_label>Study Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Serial serum LH, E2, P4</intervention_name>
      <description>Serial measurements of serum Luteinizing Hormone (LH), Estradiol (E2) and Progesterone (P4 )levels throughout the cycle to determine ovulation. LH-surge is identified when a rise of 180% above the previous level occurred and ovulation is confirmed with a decrease in E2 concentration, and a rise of progesterone level to ≥ 1.0 ng/ml (Irani et al., 2017).</description>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_label>Study Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Progesterone 100 Mg Vaginal Insert</intervention_name>
      <description>On day of ET procedure, to administer 200 mg of vaginal progesterone and increase to 300 mg/day from the day after the ET onwards until the pregnancy test. In case of an implantation, vaginal P4 will be continued until 7 weeks of pregnancy</description>
      <arm_group_label>Control Group</arm_group_label>
      <other_name>Progesterone 100Mg Vag Tab</other_name>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Serum P4 day of ET - Control Group</intervention_name>
      <description>Serum P4 will be drawn before starting LPS in form of vaginal progesterone on the day of ET procedure</description>
      <arm_group_label>Control Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Serum P4 day of ET - Study Group</intervention_name>
      <description>Serum P4 will be drawn when study group participants are admitted to the clinic for the ET procedure.</description>
      <arm_group_label>Study Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Embryo transfer</intervention_name>
      <description>The procedure in which embryo is placed in the uterus.</description>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_label>Study Group</arm_group_label>
      <other_name>ET</other_name>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Serum hCG 10 days after ET</intervention_name>
      <description>Pregnancy will be confirmed / excluded by measurement of serum hCG 10 days after ET procedure and a level of &gt; 15 IU will be regarded as positive result. The definitions of biochemical, ectopic, clinical and ongoing pregnancy follow the ICMART criteria (Zegers-Hochschild, 2006)</description>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_label>Study Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Serum P4 10 days after ET</intervention_name>
      <description>Serum P4 will be drawn on day 5 or day 6 after the ET procedure and together with the hCG 10 days after ET procedure</description>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_label>Study Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age: 18 to 40 years&#xD;
  &#xD;
            -  Regular ovulatory cycles&#xD;
  &#xD;
            -  Availability of at least one euploid embryo after Trophectoderm biopsy for PGT-A on&#xD;
               day 5 or day 6&#xD;
  &#xD;
            -  Detection of ovulation by P4 rise &gt; 1.0 ng/ml after LH surge&#xD;
  &#xD;
            -  P4 value of at least 5 ng/ml on day 4 after ovulation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of repeated pre-menstrual spotting&#xD;
  &#xD;
            -  Factors affecting the implantation through anatomical changes of the uterus / ovaries&#xD;
               or the tubes (adenomyosis, Asherman syndrome, endometriosis, uterine fibroids /&#xD;
               polyps, isthmocele with intracavitary fluid presence, hydrosalpinx….)&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Barbara Lawrenz, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>ART Fertility Clinics LLC</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Barbara Lawrenz, PhD</last_name>
      <phone>+971 800 337845489</phone>
      <email>barbara.lawrenz@artfertilityclinics.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jonalyn Edades, RN</last_name>
      <phone>+971 800 337845489</phone>
      <email>jonalyn.edades@artfertilityclinics.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>ART Fertility Clinics LLC</name>
        <address>
          <city>Abu Dhabi</city>
          <zip>60202</zip>
          <country>United Arab Emirates</country>
        </address>
      </facility>
      <contact>
        <last_name>Barbara Lawrenz, PhD</last_name>
        <phone>+971 800 337845489</phone>
        <email>barbara.lawrenz@artfertilityclinics.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>ART Fertility Clinics Al Ain</name>
        <address>
          <city>Al Ain</city>
          <country>United Arab Emirates</country>
        </address>
      </facility>
      <contact>
        <last_name>Anastasia Salame</last_name>
        <phone>+971 800 337845489</phone>
        <email>jonalyn.edades@artfertilityclinics.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>ART Fertility Clinics Dubai</name>
        <address>
          <city>Dubai</city>
          <country>United Arab Emirates</country>
        </address>
      </facility>
      <contact>
        <last_name>Carol Coughlan, PhD</last_name>
        <phone>+971 800 337845489</phone>
        <email>jonalyn.edades@artfertilityclinics.com</email>
      </contact>
    </location>
    <location_countries>
      <country>United Arab Emirates</country>
    </location_countries>
    <link>
      <url>http://link.springer.com/10.1007/978-3-319-43011-9_63</url>
      <description>Shapiro BS, Garner FC, Aguirre M. The Freeze-All Cycle: A New Paradigm Shift in ART. In Nagy ZP, Varghese AC, Agarwal A, editors. In Vitro Fertilization [Internet] 2019;, p. 765-778. Springer International Publishing</description>
    </link>
    <reference>
      <citation>Bortoletto P, Prabhu M, Baker VL. Association between programmed frozen embryo transfer and hypertensive disorders of pregnancy. Fertil Steril. 2022 Nov;118(5):839-848. doi: 10.1016/j.fertnstert.2022.07.025. Epub 2022 Sep 25.</citation>
      <PMID>36171152</PMID>
    </reference>
    <reference>
      <citation>Csapo AI, Pulkkinen M. Indispensability of the human corpus luteum in the maintenance of early pregnancy. Luteectomy evidence. Obstet Gynecol Surv. 1978 Feb;33(2):69-81. doi: 10.1097/00006254-197802000-00001. No abstract available.</citation>
      <PMID>341008</PMID>
    </reference>
    <reference>
      <citation>Filicori M, Butler JP, Crowley WF Jr. Neuroendocrine regulation of the corpus luteum in the human. Evidence for pulsatile progesterone secretion. J Clin Invest. 1984 Jun;73(6):1638-47. doi: 10.1172/JCI111370.</citation>
      <PMID>6427277</PMID>
    </reference>
    <reference>
      <citation>Ginstrom Ernstad E, Wennerholm UB, Khatibi A, Petzold M, Bergh C. Neonatal and maternal outcome after frozen embryo transfer: Increased risks in programmed cycles. Am J Obstet Gynecol. 2019 Aug;221(2):126.e1-126.e18. doi: 10.1016/j.ajog.2019.03.010. Epub 2019 Mar 22.</citation>
      <PMID>30910545</PMID>
    </reference>
    <reference>
      <citation>Pape J, Levy J, von Wolff M. Early pregnancy complications after frozen-thawed embryo transfer in different cycle regimens: A retrospective cohort study. Eur J Obstet Gynecol Reprod Biol. 2022 Dec;279:102-106. doi: 10.1016/j.ejogrb.2022.10.015. Epub 2022 Oct 21.</citation>
      <PMID>36308939</PMID>
    </reference>
    <reference>
      <citation>Roelens C, Blockeel C. Impact of different endometrial preparation protocols before frozen embryo transfer on pregnancy outcomes: a review. Fertil Steril. 2022 Nov;118(5):820-827. doi: 10.1016/j.fertnstert.2022.09.003.</citation>
      <PMID>36273850</PMID>
    </reference>
    <reference>
      <citation>Soules MR, Clifton DK, Steiner RA, Cohen NL, Bremner WJ. The corpus luteum: determinants of progesterone secretion in the normal menstrual cycle. Obstet Gynecol. 1988 May;71(5):659-66.</citation>
      <PMID>3357651</PMID>
    </reference>
    <reference>
      <citation>Su S, Zeng M, Duan J. Luteal phase support for natural cycle frozen embryo transfer: a meta-analysis. Gynecol Endocrinol. 2022 Feb;38(2):116-123. doi: 10.1080/09513590.2021.1998438. Epub 2021 Nov 3.</citation>
      <PMID>34730071</PMID>
    </reference>
    <reference>
      <citation>Practice Committee of the American Society for Reproductive Medicine. The clinical relevance of luteal phase deficiency: a committee opinion. Fertil Steril. 2012 Nov;98(5):1112-7. doi: 10.1016/j.fertnstert.2012.06.050. Epub 2012 Jul 20.</citation>
      <PMID>22819186</PMID>
    </reference>
    <reference>
      <citation>von Versen-Hoynck F, Schaub AM, Chi YY, Chiu KH, Liu J, Lingis M, Stan Williams R, Rhoton-Vlasak A, Nichols WW, Fleischmann RR, Zhang W, Winn VD, Segal MS, Conrad KP, Baker VL. Increased Preeclampsia Risk and Reduced Aortic Compliance With In Vitro Fertilization Cycles in the Absence of a Corpus Luteum. Hypertension. 2019 Mar;73(3):640-649. doi: 10.1161/HYPERTENSIONAHA.118.12043.</citation>
      <PMID>30636552</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>ART Fertility Clinics LLC</investigator_affiliation>
      <investigator_full_name>Barbara Lawrenz</investigator_full_name>
      <investigator_title>Scientific Director</investigator_title>
    </responsible_party>
    <keyword>implantation rate</keyword>
    <keyword>infertility</keyword>
    <keyword>pregnancy rate</keyword>
    <keyword>natural cycle</keyword>
    <keyword>luteal phase support</keyword>
    <keyword>live birth</keyword>
    <keyword>progesterone</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>Progesterone</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05969795
  org study id: 2306-ABU-009-BL
  nct id: NCT05969795
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  To evaluate whether single euploid embryo transfer in NC without routinely administered LPS
        is non-inferior to NC with routinely administered LPS.
  In case the study will show that the live birth rate in single euploid NC frozen embryo
        transfer cycles without LPS is not inferior to NC cycles with LPS, treatment can be
        simplified, and participants comfort can be increased.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Implantation rate
  time frame: 2 months
  description: Number of embryos which have produced ultrasonographic evidence of an intrauterine gestational sac per the total number of embryos transferred into the uterine cavity (Zegers-Hochschild et al., 2009).
  measure: Clinical pregnancy rate
  time frame: 2 months
  description: hCG > 15 Iu/ml and ultrasound confirmation of a gestational sac
  measure: Live birth rate
  time frame: 41 weeks
  description: Number of deliveries that resulted in a live born neonate, expressed per 100 embryo transfers (Zegers-Hochschild et al., 2009)
  measure: Serum P4 levels on ET day
  time frame: 1 day
  description: Progesterone level on the day of embryo transfer
  measure: Serum E2 and P4 levels on day 5 or 6 after ET procedure
  time frame: 6 days
  description: Estradiol and Progesterone levels on day 5 or 6 after embryo transfer
  measure: Serum E2 and P4 levels on day 10 after ET procedure
  time frame: 10 days
  description: Estradiol and Progesterone levels on day 10 after embryo transfer
  arm group label: Study Group
  arm group type: Other
  description: Intermittent ultrasound scans to monitor follicular growth and serial measurements of serum LH, E2 and P4 levels throughout the cycle to determine ovulation. Embryo transfer (ET) will be scheduled on the fifth day after ovulation. Blood for P4 measurement will be drawn upon admission to the clinic for the ET procedure. P4 will be measured on day 5 or day 6 after the ET procedure and together with the hCG 10 days after ET procedure.
  arm group label: Control Group
  arm group type: Other
  description: Intermittent ultrasound scans to monitor follicular growth and serial measurements of serum LH, E2 and P4 levels throughout the cycle to determine ovulation. Embryo transfer (ET) will be scheduled on the fifth day after ovulation. Administer on FET day 200 mg of P4 and increase to 300 mg/day from the day after the ET onwards until the pregnancy test. Blood for P4 measurement will be drawn before starting LPS in form of vaginal progesterone. P4 will be measured on day 5 or day 6 after the ET procedure and together with the hCG 10 days after ET procedure. In case of an implantation, vaginal P4 will be continued until 7 weeks of pregnancy.
  intervention type: Diagnostic Test
  intervention name: Transvaginal ultrasound
  description: Intermittent transvaginal ultrasound throughout the cycle to monitor follicular growth
  arm group label: Control Group
  arm group label: Study Group
  intervention type: Diagnostic Test
  intervention name: Serial serum LH, E2, P4
  description: Serial measurements of serum Luteinizing Hormone (LH), Estradiol (E2) and Progesterone (P4 )levels throughout the cycle to determine ovulation. LH-surge is identified when a rise of 180% above the previous level occurred and ovulation is confirmed with a decrease in E2 concentration, and a rise of progesterone level to ≥ 1.0 ng/ml (Irani et al., 2017).
  arm group label: Control Group
  arm group label: Study Group
  intervention type: Drug
  intervention name: Progesterone 100 Mg Vaginal Insert
  description: On day of ET procedure, to administer 200 mg of vaginal progesterone and increase to 300 mg/day from the day after the ET onwards until the pregnancy test. In case of an implantation, vaginal P4 will be continued until 7 weeks of pregnancy
  arm group label: Control Group
  other name: Progesterone 100Mg Vag Tab
  intervention type: Diagnostic Test
  intervention name: Serum P4 day of ET - Control Group
  description: Serum P4 will be drawn before starting LPS in form of vaginal progesterone on the day of ET procedure
  arm group label: Control Group
  intervention type: Diagnostic Test
  intervention name: Serum P4 day of ET - Study Group
  description: Serum P4 will be drawn when study group participants are admitted to the clinic for the ET procedure.
  arm group label: Study Group
  intervention type: Procedure
  intervention name: Embryo transfer
  description: The procedure in which embryo is placed in the uterus.
  arm group label: Control Group
  arm group label: Study Group
  other name: ET
  intervention type: Diagnostic Test
  intervention name: Serum hCG 10 days after ET
  description: Pregnancy will be confirmed / excluded by measurement of serum hCG 10 days after ET procedure and a level of > 15 IU will be regarded as positive result. The definitions of biochemical, ectopic, clinical and ongoing pregnancy follow the ICMART criteria (Zegers-Hochschild, 2006)
  arm group label: Control Group
  arm group label: Study Group
  intervention type: Diagnostic Test
  intervention name: Serum P4 10 days after ET
  description: Serum P4 will be drawn on day 5 or day 6 after the ET procedure and together with the hCG 10 days after ET procedure
  arm group label: Control Group
  arm group label: Study Group
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Barbara Lawrenz, PhD
  role: Principal Investigator
  affiliation: ART Fertility Clinics LLC
  last name: Barbara Lawrenz, PhD
  phone: +971 800 337845489
  email: barbara.lawrenz@artfertilityclinics.com
  last name: Jonalyn Edades, RN
  phone: +971 800 337845489
  email: jonalyn.edades@artfertilityclinics.com
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  country: United Arab Emirates
  url: http://link.springer.com/10.1007/978-3-319-43011-9_63
  description: Shapiro BS, Garner FC, Aguirre M. The Freeze-All Cycle: A New Paradigm Shift in ART. In Nagy ZP, Varghese AC, Agarwal A, editors. In Vitro Fertilization [Internet] 2019;, p. 765-778. Springer International Publishing
  citation: Bortoletto P, Prabhu M, Baker VL. Association between programmed frozen embryo transfer and hypertensive disorders of pregnancy. Fertil Steril. 2022 Nov;118(5):839-848. doi: 10.1016/j.fertnstert.2022.07.025. Epub 2022 Sep 25.
  PMID: 36171152
  citation: Csapo AI, Pulkkinen M. Indispensability of the human corpus luteum in the maintenance of early pregnancy. Luteectomy evidence. Obstet Gynecol Surv. 1978 Feb;33(2):69-81. doi: 10.1097/00006254-197802000-00001. No abstract available.
  PMID: 341008
  citation: Filicori M, Butler JP, Crowley WF Jr. Neuroendocrine regulation of the corpus luteum in the human. Evidence for pulsatile progesterone secretion. J Clin Invest. 1984 Jun;73(6):1638-47. doi: 10.1172/JCI111370.
  PMID: 6427277
  citation: Ginstrom Ernstad E, Wennerholm UB, Khatibi A, Petzold M, Bergh C. Neonatal and maternal outcome after frozen embryo transfer: Increased risks in programmed cycles. Am J Obstet Gynecol. 2019 Aug;221(2):126.e1-126.e18. doi: 10.1016/j.ajog.2019.03.010. Epub 2019 Mar 22.
  PMID: 30910545
  citation: Pape J, Levy J, von Wolff M. Early pregnancy complications after frozen-thawed embryo transfer in different cycle regimens: A retrospective cohort study. Eur J Obstet Gynecol Reprod Biol. 2022 Dec;279:102-106. doi: 10.1016/j.ejogrb.2022.10.015. Epub 2022 Oct 21.
  PMID: 36308939
  citation: Roelens C, Blockeel C. Impact of different endometrial preparation protocols before frozen embryo transfer on pregnancy outcomes: a review. Fertil Steril. 2022 Nov;118(5):820-827. doi: 10.1016/j.fertnstert.2022.09.003.
  PMID: 36273850
  citation: Soules MR, Clifton DK, Steiner RA, Cohen NL, Bremner WJ. The corpus luteum: determinants of progesterone secretion in the normal menstrual cycle. Obstet Gynecol. 1988 May;71(5):659-66.
  PMID: 3357651
  citation: Su S, Zeng M, Duan J. Luteal phase support for natural cycle frozen embryo transfer: a meta-analysis. Gynecol Endocrinol. 2022 Feb;38(2):116-123. doi: 10.1080/09513590.2021.1998438. Epub 2021 Nov 3.
  PMID: 34730071
  citation: Practice Committee of the American Society for Reproductive Medicine. The clinical relevance of luteal phase deficiency: a committee opinion. Fertil Steril. 2012 Nov;98(5):1112-7. doi: 10.1016/j.fertnstert.2012.06.050. Epub 2012 Jul 20.
  PMID: 22819186
  citation: von Versen-Hoynck F, Schaub AM, Chi YY, Chiu KH, Liu J, Lingis M, Stan Williams R, Rhoton-Vlasak A, Nichols WW, Fleischmann RR, Zhang W, Winn VD, Segal MS, Conrad KP, Baker VL. Increased Preeclampsia Risk and Reduced Aortic Compliance With In Vitro Fertilization Cycles in the Absence of a Corpus Luteum. Hypertension. 2019 Mar;73(3):640-649. doi: 10.1161/HYPERTENSIONAHA.118.12043.
  PMID: 30636552
  responsible party type: Principal Investigator
  investigator affiliation: ART Fertility Clinics LLC
  investigator full name: Barbara Lawrenz
  investigator title: Scientific Director
  mesh term: Infertility
  mesh term: Infertility, Female
  mesh term: Progesterone