<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT201108044339N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-09-22</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>natural frozen – thawed embryo transfer cycles</public_title>
      <acronym>IVF</acronym>
      <scientific_title>effect of progesterone in natural frozen – thawed embryo transfer cycles</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-03-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>109</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/4620</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomized to either group in a ratio of 1:1 by means of computer-generated random numbers on the day of participation. Group selection and randomization were performed by a nurse not involved in the study, by using opaque sealed envelopes. Both the patients and the clinicians were aware of the allocated arm.</study_design>
      <phase>2</phase>
      <hc_freetext>female infertility.</hc_freetext>
      <i_freetext>Intervention 1: On the second or third days of the menstrual cycle, all patients underwent transvaginal ultrasounds and serum hormone analysis for FSH. Then, a vaginal ultrasonographic examination was performed on cycle days 10 and repeated as necessary. Final oocyte maturation was achieved by intramuscular (IM) administration of 10000 IU of hCG (Pregnyl, Daropakhsh, Iran) when an endometrial thickness of 8 mm or more and a follicle of 18 mm were present on the ultrasound. On the day of the hCG administration, we measured serum estradiol‚ progesterone and LH levels.The progesterone group received 100mg/day of progesterone (Aburaihan Pharmaceutical Co., Tehran, Iran) IM, that began 36 hours after the hCG administration and continued until ten weeks of gestation if pregnancy occurred.  In both groups, cryopreserved embryo transfer was performed with a Cook catheter (Cook Ireland Ltd.) five days after hCG administration. Serum β-hCG level was measured 14 days after the transfer. Intervention 2: In control group :On the second or third days of the menstrual cycle, all patients underwent transvaginal ultrasounds and serum hormone analysis for FSH. Then, a vaginal ultrasonographic examination was performed on cycle days 10 and repeated as necessary. Final oocyte maturation was achieved by intramuscular (IM) administration of 10000 IU of hCG (Pregnyl, Daropakhsh, Iran) when an endometrial thickness of 8 mm or more and a follicle of 18 mm were present on the ultrasound. On the day of the hCG administration, we measured serum estradiol‚ progesterone and LH levels.Control patients received no progesterone. In both groups, cryopreserved embryo transfer was performed with a Cook catheter (Cook Ireland Ltd.) five days after hCG administration. Serum β-hCG level was measured 14 days after the transfer.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link>https://www.ijfs.ir/article_45164.html</results_url_link>
      <results_summary>Abstract
Background: The transfer of cryopreserved embryos can be timed with ovulation in a natural cycle or after artificially preparing the endometrium with exogenous hormones. Progesterone is essential for the secretory transformation of the endometrium that permits implantation as well as maintenance of early pregnancy. The purpose of this study is to assess the effect of luteal phase supplementation on pregnancy rates in natural frozen-thawed cycles. Materials and Methods: The study was designed as a prospective randomized clinical trial of 102 women who underwent embryo transfers in natural cycles. The women in the interventional group (n=51) received intra muscular (IM) progesterone 50 mg twice a day starting from 36 hours after hCG administration. The control group (n=51) did not receive any progesterone support. Results: There were no significant differences in demographic characteristics between the groups and no statistically significant differences were observed between study and control groups in clinical pregnancy rate (33.3% vs. 27.5%, p=0.66). There were no differences in implantation rate or spontaneous abortion rate. Conclusion: Our results suggest that luteal phase support does not affect clinical pregnancy rates in natural frozen-thawed embryo transfer cycles (Registration Number: IRCT201108044339N6).</results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Due to the privacy of patients</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Mozhgan Rahsepar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877391</zip>
        <telephone>+98 35 1824 7085</telephone>
        <email>drrahsepar@hotmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Maryam Eftekhar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8916877391</zip>
        <telephone>+98 35 1824 7085</telephone>
        <email>eftekharmaryam@yahoo.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>cryop reserved embryos after conventional in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)
maternal age of 20-40 years (on the day of embryo freezing)
regular menstrual cycle of 25-35 days
body mass index of 20-27 kg/m2</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>the use of testicular sperm for ICSI (ejaculated sperm only)
basal follicle stimulating hormone
stage III-IV endometriosis
polycystic ovarian syndrome (PCOS)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N97</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>female infertility</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>On the second or third days of the menstrual cycle, all patients underwent transvaginal ultrasounds and serum hormone analysis for FSH. Then, a vaginal ultrasonographic examination was performed on cycle days 10 and repeated as necessary. Final oocyte maturation was achieved by intramuscular (IM) administration of 10000 IU of hCG (Pregnyl, Daropakhsh, Iran) when an endometrial thickness of 8 mm or more and a follicle of 18 mm were present on the ultrasound. On the day of the hCG administration, we measured serum estradiol‚ progesterone and LH levels.The progesterone group received 100mg/day of progesterone (Aburaihan Pharmaceutical Co., Tehran, Iran) IM, that began 36 hours after the hCG administration and continued until ten weeks of gestation if pregnancy occurred.  In both groups, cryopreserved embryo transfer was performed with a Cook catheter (Cook Ireland Ltd.) five days after hCG administration. Serum β-hCG level was measured 14 days after the transfer.</i_keyword>
      <i_keyword>In control group :On the second or third days of the menstrual cycle, all patients underwent transvaginal ultrasounds and serum hormone analysis for FSH. Then, a vaginal ultrasonographic examination was performed on cycle days 10 and repeated as necessary. Final oocyte maturation was achieved by intramuscular (IM) administration of 10000 IU of hCG (Pregnyl, Daropakhsh, Iran) when an endometrial thickness of 8 mm or more and a follicle of 18 mm were present on the ultrasound. On the day of the hCG administration, we measured serum estradiol‚ progesterone and LH levels.Control patients received no progesterone. In both groups, cryopreserved embryo transfer was performed with a Cook catheter (Cook Ireland Ltd.) five days after hCG administration. Serum β-hCG level was measured 14 days after the transfer.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Chemical pregnancy. Timepoint: 14 days after embryo transfer. Method of measurement: BHCG TEST.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Clinical pregnancy. Timepoint: 4-5 weeks after embryo transfer. Method of measurement: Obestetrics sonography.</sec_outcome>
      <sec_outcome>Implantation rates. Timepoint: Five weeks after embryo transfer. Method of measurement: The number of pregnancy sacs divided by the number of transferred embryos multiplied by 100.</sec_outcome>
      <sec_outcome>Clinical abortion. Timepoint: before20 weeks of gestation. Method of measurement: as clinically.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-06-20</approval_date>
        <contact_name>Yazd research and clinical center for infertility</contact_name>
        <contact_address>Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
