<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/NCT04507022</url>
  </required_header>
  <id_info>
    <org_study_id>RFC041120190008</org_study_id>
    <nct_id>NCT04507022</nct_id>
  </id_info>
  <brief_title>The Outcome of Two Protocols Used to Prepare Endometrium for Frozen Embryo Transfer</brief_title>
  <official_title>A Randomized Controlled Study to Compare the Outcome of Two Protocols Used to Prepare the Endometrium for Frozen Embryo Transfer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rahem Fertility Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rahem Fertility Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a RCT to test the outcome of two protocols used for preparation of the endometrium&#xD;
      for frozen blastocyst embryo transfer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Receptive endometrium and a good quality embryo at the blastocyst developmental stage are&#xD;
      prerequisites for a successful implantation to occur. Blastocyst freezing techniques and&#xD;
      survival have witnessed huge improvements in the last years. Trials to improve the outcome of&#xD;
      frozen embryo transfer (FET) are not to be stopped. The transfer of a good quality blastocyst&#xD;
      represents a vital part of the process. Optimization of endometrial receptivity and&#xD;
      implantation is an everlasting challenge.&#xD;
&#xD;
      Hormone replacement therapy (HRT) is now proven to be successful for preparation of the&#xD;
      endometrium to receive the vitrified warmed embryos. Most HRT protocols give estradiol (E2)&#xD;
      first to reach a satisfactory endometrial thickness, then followed by progesterone to mimic&#xD;
      the natural cycles. E2 is mostly given for 10 to 14 days and this duration might be prolonged&#xD;
      to reach a satisfactory endometrial thickness without adversely affecting the outcome.&#xD;
      Trans-vaginal ultrasound assessment of the endometrial thickness before the start of P&#xD;
      supplementation has been traditionally used to predict FET cycle outcome. Clinical pregnancy&#xD;
      rates (CPR) and live birth rates (LBR) were found to decrease for each millimetre of&#xD;
      endometrial thickness below 7 mm. Endometrial thickness however of 9 mm was reported to be&#xD;
      among major factors affecting LBR after FET in a large set of data.&#xD;
&#xD;
      Further, there is a recent concept that endometrial compaction (decreased thickness) between&#xD;
      the end of estrogen phase and the day of ET has favorable impact on the outcome of FET.&#xD;
      Different modalities were proposed to enhance endometrial compaction. One of these modalities&#xD;
      was to decrease the dose of estrogen so as to change the estrogen- progesterone ratio as well&#xD;
      as help in preventing further endometrial growth.&#xD;
&#xD;
      Aromatase inhibitor (AI) can be used to decrease estrogen before starting P supplementation.&#xD;
      Additionally, there were also reports that their use had been associated with improved&#xD;
      implantation. It appears interesting to combine the easy scheduled HRT protocol with&#xD;
      aromatase inhibitor to maximize FET outcome.&#xD;
&#xD;
      This proposed protocol has not been tested before. In current study, HRT plus AI will be&#xD;
      compared with HRT only. In both groups, daily intramuscular P will be given for luteal&#xD;
      support as it was shown to give the highest ongoing pregnancy rate in FET cycles.&#xD;
&#xD;
      We did a secondary follow up analysis of some exploratory outcomes (not preregistered). These&#xD;
      outcomes were analyzed after publication and they include Live birth rate, implantation rate,&#xD;
      hypertensive disorders of pregnancy, large for gestation and congenital anomalies. The&#xD;
      results of these outcomes are planned to be presented elsewhere. For openness and&#xD;
      transparency, we felt the importance to report this follow up in the registry.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 12, 2020</start_date>
  <completion_date type="Actual">February 5, 2021</completion_date>
  <primary_completion_date type="Actual">February 5, 2021</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ongoing Pregnancy Rate</measure>
    <time_frame>at 12 weeks of gestation</time_frame>
    <description>visualization of fetal cardiac pulsation by ultrasound</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>endometrial compaction</measure>
    <time_frame>from the end of estradiol phase to the day of embryo transfer up to 11 days</time_frame>
    <description>change in endometrial thickness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>clinical pregnancy rate</measure>
    <time_frame>6 weeks gestation</time_frame>
    <description>visualization of fetal cardiac pulsation by ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Live birth rate</measure>
    <time_frame>24 weeks</time_frame>
    <description>The birth of at least one newborn that exhibits any sign of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implantation rate</measure>
    <time_frame>6 weeks gestation</time_frame>
    <description>The number of gestational sacs observed divided by the number of embryos transferred expressed as a percentage, %</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Hypertensive disorders of pregnancy</measure>
    <time_frame>20 weeks gestation till postpartum</time_frame>
    <description>gestational hypertension or preeclampsia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Large for gestational age</measure>
    <time_frame>from gestation till delivery]</time_frame>
    <description>A birth weight greater than the 90th centile of the sex-specific birth weight for a given gestational age reference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Congenital anomalies</measure>
    <time_frame>during pregnancy and after birth (one month after birth)</time_frame>
    <description>Structural or functional disorders that occur during intra-uterine life and can be identified prenatally, at birth or later in life.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">112</enrollment>
  <condition>Infertility</condition>
  <condition>Infertility, Female</condition>
  <condition>Infertility, Male</condition>
  <arm_group>
    <arm_group_label>HRT Plus Aromatase Inhibitor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hormone replacement treatment (HRT) will be used in all cases. Exogenous estradiol will be started on day 2 or 3 of the cycle. In all participants, 2 mg oral estradiol valerate, will be administered three times daily. Ultrasound evaluation of endometrium will be performed 10 to 12 days after starting E2. Trilaminar endometrium of 9 mm will be the targeted cutoff . If not yet ready, E2 supplementation will be continued with serial US assessment until the desired cutoff is achieved. Thereafter, participants will be randomized to two groups:&#xD;
Group A (HRT plus AI): will be given aromatase inhibitor for 5 days only (2.5 mg twice daily), along with the oral 6 mg E2. Then, daily intramuscular (IM) P in oil (100 mg IM P) will be started in addition to the daily dose of oral 6 mg E2.&#xD;
In both groups, embryos will be warmed on the 6th day of P supplementation. Before undergoing FET, endometrial thickness will be re-evaluated. IM P and 6mg E2 will be continued thereafter.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HRT Only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hormone replacement treatment (HRT) will be used in all cases. Exogenous estradiol will be started on day 2 or 3 of the cycle. In all participants, 2 mg oral estradiol valerate, will be administered three times daily. Ultrasound evaluation of endometrium will be performed 10 to 12 days after starting E2. Trilaminar endometrium of 9 mm will be the targeted cutoff . If not yet ready, E2 supplementation will be continued with serial US assessment until the desired cutoff is achieved. Thereafter, participants will be randomized to two groups Group B (HRT only): will be administered daily intramuscular (IM) P in oil (100 mg IM P) in addition to the daily dose of oral 6 mg E2.&#xD;
In both groups, embryos will be warmed on the 6th day of P supplementation. Before undergoing FET, endometrial thickness will be re-evaluated. IM P and 6mg E2 will be continued thereafter.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Estradiol Valerate</intervention_name>
    <description>2mg three times daily</description>
    <arm_group_label>HRT Only</arm_group_label>
    <arm_group_label>HRT Plus Aromatase Inhibitor</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Progesterone</intervention_name>
    <description>100 mg daily intramuscular</description>
    <arm_group_label>HRT Only</arm_group_label>
    <arm_group_label>HRT Plus Aromatase Inhibitor</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aromatase inhibitor</intervention_name>
    <description>2.5 mg twice daily for 5 days</description>
    <arm_group_label>HRT Plus Aromatase Inhibitor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:Inclusion criteria:&#xD;
&#xD;
          -  Women aged from18 - 37 years old undergoing FET using good quality blastocysts&#xD;
             vitrified on day 5(3 BB and more) (according to Gardner and Schoolcraft 1999) (8).&#xD;
&#xD;
          -  Participants having at least one good quality blastocyst (3BB and more) available for&#xD;
             transfer after warming.&#xD;
&#xD;
          -  Participants having trilaminar endometrium of 9 mm after E2 preparation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women younger than 18 or older than 37 years old.&#xD;
&#xD;
          -  Women who have uterine abnormality or pathology.&#xD;
&#xD;
          -  Women who will not meet the inclusion criteria.&#xD;
&#xD;
          -  Women who will refuse to participate in in the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>37 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rahem Fertility Center</name>
      <address>
        <city>Zagazig</city>
        <state>Sharkia</state>
        <zip>44519</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Mackens S, Santos-Ribeiro S, van de Vijver A, Racca A, Van Landuyt L, Tournaye H, Blockeel C. Frozen embryo transfer: a review on the optimal endometrial preparation and timing. Hum Reprod. 2017 Nov 1;32(11):2234-2242. doi: 10.1093/humrep/dex285.</citation>
    <PMID>29025055</PMID>
  </reference>
  <reference>
    <citation>Sekhon L, Feuerstein J, Pan S, Overbey J, Lee JA, Briton-Jones C, Flisser E, Stein DE, Mukherjee T, Grunfeld L, Sandler B, Copperman AB. Endometrial preparation before the transfer of single, vitrified-warmed, euploid blastocysts: does the duration of estradiol treatment influence clinical outcome? Fertil Steril. 2019 Jun;111(6):1177-1185.e3. doi: 10.1016/j.fertnstert.2019.02.024. Epub 2019 Apr 24.</citation>
    <PMID>31029432</PMID>
  </reference>
  <reference>
    <citation>Liu KE, Hartman M, Hartman A, Luo ZC, Mahutte N. The impact of a thin endometrial lining on fresh and frozen-thaw IVF outcomes: an analysis of over 40 000 embryo transfers. Hum Reprod. 2018 Oct 1;33(10):1883-1888. doi: 10.1093/humrep/dey281.</citation>
    <PMID>30239738</PMID>
  </reference>
  <reference>
    <citation>Pan Y, Hao G, Wang Q, Liu H, Wang Z, Jiang Q, Shi Y, Chen ZJ. Major Factors Affecting the Live Birth Rate After Frozen Embryo Transfer Among Young Women. Front Med (Lausanne). 2020 Mar 24;7:94. doi: 10.3389/fmed.2020.00094. eCollection 2020.</citation>
    <PMID>32266278</PMID>
  </reference>
  <reference>
    <citation>Haas J, Smith R, Zilberberg E, Nayot D, Meriano J, Barzilay E, Casper RF. Endometrial compaction (decreased thickness) in response to progesterone results in optimal pregnancy outcome in frozen-thawed embryo transfers. Fertil Steril. 2019 Sep;112(3):503-509.e1. doi: 10.1016/j.fertnstert.2019.05.001. Epub 2019 Jun 24.</citation>
    <PMID>31248618</PMID>
  </reference>
  <reference>
    <citation>Devine K, Richter KS, Widra EA, McKeeby JL. Vitrified blastocyst transfer cycles with the use of only vaginal progesterone replacement with Endometrin have inferior ongoing pregnancy rates: results from the planned interim analysis of a three-arm randomized controlled noninferiority trial. Fertil Steril. 2018 Feb;109(2):266-275. doi: 10.1016/j.fertnstert.2017.11.004. Epub 2018 Jan 17.</citation>
    <PMID>29338855</PMID>
  </reference>
  <reference>
    <citation>Miller PB, Parnell BA, Bushnell G, Tallman N, Forstein DA, Higdon HL 3rd, Kitawaki J, Lessey BA. Endometrial receptivity defects during IVF cycles with and without letrozole. Hum Reprod. 2012 Mar;27(3):881-8. doi: 10.1093/humrep/der452. Epub 2012 Jan 13.</citation>
    <PMID>22246449</PMID>
  </reference>
  <reference>
    <citation>Gardner DK, Schoolcraft WB. Culture and transfer of human blastocysts. Curr Opin Obstet Gynecol. 1999 Jun;11(3):307-11. doi: 10.1097/00001703-199906000-00013.</citation>
    <PMID>10369209</PMID>
  </reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>August 1, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>April 20, 2022</last_update_submitted>
  <last_update_submitted_qc>April 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Infertility, Female</mesh_term>
    <mesh_term>Infertility, Male</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Estradiol 17 beta-cypionate</mesh_term>
    <mesh_term>Estradiol 3-benzoate</mesh_term>
    <mesh_term>Estradiol</mesh_term>
    <mesh_term>Polyestradiol phosphate</mesh_term>
    <mesh_term>Progesterone</mesh_term>
    <mesh_term>Aromatase Inhibitors</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04507022
org study id: RFC041120190008
nct id: NCT04507022
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a RCT to test the outcome of two protocols used for preparation of the endometrium
      for frozen blastocyst embryo transfer
Receptive endometrium and a good quality embryo at the blastocyst developmental stage are
      prerequisites for a successful implantation to occur. Blastocyst freezing techniques and
      survival have witnessed huge improvements in the last years. Trials to improve the outcome of
      frozen embryo transfer (FET) are not to be stopped. The transfer of a good quality blastocyst
      represents a vital part of the process. Optimization of endometrial receptivity and
      implantation is an everlasting challenge.

      Hormone replacement therapy (HRT) is now proven to be successful for preparation of the
      endometrium to receive the vitrified warmed embryos. Most HRT protocols give estradiol (E2)
      first to reach a satisfactory endometrial thickness, then followed by progesterone to mimic
      the natural cycles. E2 is mostly given for 10 to 14 days and this duration might be prolonged
      to reach a satisfactory endometrial thickness without adversely affecting the outcome.
      Trans-vaginal ultrasound assessment of the endometrial thickness before the start of P
      supplementation has been traditionally used to predict FET cycle outcome. Clinical pregnancy
      rates (CPR) and live birth rates (LBR) were found to decrease for each millimetre of
      endometrial thickness below 7 mm. Endometrial thickness however of 9 mm was reported to be
      among major factors affecting LBR after FET in a large set of data.

      Further, there is a recent concept that endometrial compaction (decreased thickness) between
      the end of estrogen phase and the day of ET has favorable impact on the outcome of FET.
      Different modalities were proposed to enhance endometrial compaction. One of these modalities
      was to decrease the dose of estrogen so as to change the estrogen- progesterone ratio as well
      as help in preventing further endometrial growth.

      Aromatase inhibitor (AI) can be used to decrease estrogen before starting P supplementation.
      Additionally, there were also reports that their use had been associated with improved
      implantation. It appears interesting to combine the easy scheduled HRT protocol with
      aromatase inhibitor to maximize FET outcome.

      This proposed protocol has not been tested before. In current study, HRT plus AI will be
      compared with HRT only. In both groups, daily intramuscular P will be given for luteal
      support as it was shown to give the highest ongoing pregnancy rate in FET cycles.

      We did a secondary follow up analysis of some exploratory outcomes (not preregistered). These
      outcomes were analyzed after publication and they include Live birth rate, implantation rate,
      hypertensive disorders of pregnancy, large for gestation and congenital anomalies. The
      results of these outcomes are planned to be presented elsewhere. For openness and
      transparency, we felt the importance to report this follow up in the registry.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Ongoing Pregnancy Rate
time frame: at 12 weeks of gestation
description: visualization of fetal cardiac pulsation by ultrasound
measure: endometrial compaction
time frame: from the end of estradiol phase to the day of embryo transfer up to 11 days
description: change in endometrial thickness
measure: clinical pregnancy rate
time frame: 6 weeks gestation
description: visualization of fetal cardiac pulsation by ultrasound
measure: Live birth rate
time frame: 24 weeks
description: The birth of at least one newborn that exhibits any sign of life
measure: Implantation rate
time frame: 6 weeks gestation
description: The number of gestational sacs observed divided by the number of embryos transferred expressed as a percentage, %
measure: Number of participants with Hypertensive disorders of pregnancy
time frame: 20 weeks gestation till postpartum
description: gestational hypertension or preeclampsia
measure: Number of participants with Large for gestational age
time frame: from gestation till delivery]
description: A birth weight greater than the 90th centile of the sex-specific birth weight for a given gestational age reference.
measure: Rate of Congenital anomalies
time frame: during pregnancy and after birth (one month after birth)
description: Structural or functional disorders that occur during intra-uterine life and can be identified prenatally, at birth or later in life.
arm group label: HRT Plus Aromatase Inhibitor
arm group type: Experimental
description: Hormone replacement treatment (HRT) will be used in all cases. Exogenous estradiol will be started on day 2 or 3 of the cycle. In all participants, 2 mg oral estradiol valerate, will be administered three times daily. Ultrasound evaluation of endometrium will be performed 10 to 12 days after starting E2. Trilaminar endometrium of 9 mm will be the targeted cutoff . If not yet ready, E2 supplementation will be continued with serial US assessment until the desired cutoff is achieved. Thereafter, participants will be randomized to two groups:
Group A (HRT plus AI): will be given aromatase inhibitor for 5 days only (2.5 mg twice daily), along with the oral 6 mg E2. Then, daily intramuscular (IM) P in oil (100 mg IM P) will be started in addition to the daily dose of oral 6 mg E2.
In both groups, embryos will be warmed on the 6th day of P supplementation. Before undergoing FET, endometrial thickness will be re-evaluated. IM P and 6mg E2 will be continued thereafter.
arm group label: HRT Only
arm group type: Active Comparator
description: Hormone replacement treatment (HRT) will be used in all cases. Exogenous estradiol will be started on day 2 or 3 of the cycle. In all participants, 2 mg oral estradiol valerate, will be administered three times daily. Ultrasound evaluation of endometrium will be performed 10 to 12 days after starting E2. Trilaminar endometrium of 9 mm will be the targeted cutoff . If not yet ready, E2 supplementation will be continued with serial US assessment until the desired cutoff is achieved. Thereafter, participants will be randomized to two groups Group B (HRT only): will be administered daily intramuscular (IM) P in oil (100 mg IM P) in addition to the daily dose of oral 6 mg E2.
In both groups, embryos will be warmed on the 6th day of P supplementation. Before undergoing FET, endometrial thickness will be re-evaluated. IM P and 6mg E2 will be continued thereafter.
intervention type: Drug
intervention name: Estradiol Valerate
description: 2mg three times daily
arm group label: HRT Only
arm group label: HRT Plus Aromatase Inhibitor
intervention type: Drug
intervention name: Progesterone
description: 100 mg daily intramuscular
arm group label: HRT Only
arm group label: HRT Plus Aromatase Inhibitor
intervention type: Drug
intervention name: Aromatase inhibitor
description: 2.5 mg twice daily for 5 days
arm group label: HRT Plus Aromatase Inhibitor
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 37 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
citation: Mackens S, Santos-Ribeiro S, van de Vijver A, Racca A, Van Landuyt L, Tournaye H, Blockeel C. Frozen embryo transfer: a review on the optimal endometrial preparation and timing. Hum Reprod. 2017 Nov 1;32(11):2234-2242. doi: 10.1093/humrep/dex285.
PMID: 29025055
citation: Sekhon L, Feuerstein J, Pan S, Overbey J, Lee JA, Briton-Jones C, Flisser E, Stein DE, Mukherjee T, Grunfeld L, Sandler B, Copperman AB. Endometrial preparation before the transfer of single, vitrified-warmed, euploid blastocysts: does the duration of estradiol treatment influence clinical outcome? Fertil Steril. 2019 Jun;111(6):1177-1185.e3. doi: 10.1016/j.fertnstert.2019.02.024. Epub 2019 Apr 24.
PMID: 31029432
citation: Liu KE, Hartman M, Hartman A, Luo ZC, Mahutte N. The impact of a thin endometrial lining on fresh and frozen-thaw IVF outcomes: an analysis of over 40 000 embryo transfers. Hum Reprod. 2018 Oct 1;33(10):1883-1888. doi: 10.1093/humrep/dey281.
PMID: 30239738
citation: Pan Y, Hao G, Wang Q, Liu H, Wang Z, Jiang Q, Shi Y, Chen ZJ. Major Factors Affecting the Live Birth Rate After Frozen Embryo Transfer Among Young Women. Front Med (Lausanne). 2020 Mar 24;7:94. doi: 10.3389/fmed.2020.00094. eCollection 2020.
PMID: 32266278
citation: Haas J, Smith R, Zilberberg E, Nayot D, Meriano J, Barzilay E, Casper RF. Endometrial compaction (decreased thickness) in response to progesterone results in optimal pregnancy outcome in frozen-thawed embryo transfers. Fertil Steril. 2019 Sep;112(3):503-509.e1. doi: 10.1016/j.fertnstert.2019.05.001. Epub 2019 Jun 24.
PMID: 31248618
citation: Devine K, Richter KS, Widra EA, McKeeby JL. Vitrified blastocyst transfer cycles with the use of only vaginal progesterone replacement with Endometrin have inferior ongoing pregnancy rates: results from the planned interim analysis of a three-arm randomized controlled noninferiority trial. Fertil Steril. 2018 Feb;109(2):266-275. doi: 10.1016/j.fertnstert.2017.11.004. Epub 2018 Jan 17.
PMID: 29338855
citation: Miller PB, Parnell BA, Bushnell G, Tallman N, Forstein DA, Higdon HL 3rd, Kitawaki J, Lessey BA. Endometrial receptivity defects during IVF cycles with and without letrozole. Hum Reprod. 2012 Mar;27(3):881-8. doi: 10.1093/humrep/der452. Epub 2012 Jan 13.
PMID: 22246449
citation: Gardner DK, Schoolcraft WB. Culture and transfer of human blastocysts. Curr Opin Obstet Gynecol. 1999 Jun;11(3):307-11. doi: 10.1097/00001703-199906000-00013.
PMID: 10369209
responsible party type: Sponsor
mesh term: Infertility
mesh term: Infertility, Female
mesh term: Infertility, Male
mesh term: Estradiol 17 beta-cypionate
mesh term: Estradiol 3-benzoate
mesh term: Estradiol
mesh term: Polyestradiol phosphate
mesh term: Progesterone
mesh term: Aromatase Inhibitors