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出境医 / 临床实验 / Freeze-all Policy in Poor Responders

Freeze-all Policy in Poor Responders

Study Description
Brief Summary:
To compare the effects of fresh embryo transfers (ET) and elective frozen-thawed embryo transfer cycles in poor ovarian responders.

Condition or disease Intervention/treatment Phase
Infertility, Female Other: Freeze-all policy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Blinding of the allocated intervention is not possible.
Primary Purpose: Other
Official Title: Fresh Versus Frozen Embryos for Infertility in the Poor Responders as Defined by the Bologna Criteria
Actual Study Start Date : July 30, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : December 30, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Freeze-all
Good quality embryos (either day 3 or 5) will be frozen and subsequent frozen embryo transfer will be arranged within three months of the egg retrival.
 Other: Freeze-all policy
A policy of freezing all the embryos followed by subsequent thawed frozen embryo transfer
No Intervention: Fresh embryo transfer
Women will undergo fresh embryo transfer at the cleavage (day 3) or blastocyst stage (day 5).
Outcome Measures
Primary Outcome Measures :
  1. Livebirth rate [ Time Frame: 32 weeks ]
    The proportion of women in the population who had at least one live baby.


Secondary Outcome Measures :
  1. Pregnancy rate [ Time Frame: 2 weeks ]
    Positive pregnancy test at two weeks +/- three days after embryo transfer

  2. Clinical pregnancy rate [ Time Frame: 6-8 weeks ]
    The presence of at least one fetal heartbeat at ultrasound between six and eight weeks of gestation


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients that fulfill the Bologna criteria [at least 2 of the following 3 features must be present: (i) advanced maternal age or any other risk factor for POR; (ii) a previous POR; and (iii) an abnormal ovarian reserve test (ORT)]
  • if the progesterone serum level was ≤1.5 ng/mL on the trigger day.
  • body mass index 18-32 kg/m2
  • Both partners are able to provide written informed consent.
  • At least 1 good quality embryo on day 3 after egg collection on day 3 according to the Istanbul consensus (7-8 cells; with symmetric blastomeres and <10% fragmentation by volume).
  • Endometrial thickness ≥8 mm on trigger day.
  • a normal uterine cavity on ultrasound.
  • IVF/ICSI with only fresh semen

Exclusion Criteria:

  • Pre-implantation genetic testing is being planned.
  • if they had severe endometriosis, uterine pathology (myomas, adenomyosis, endocrinopathies, adhesions, acquired or congenital abnormalities), untreated tubal hydrosalpinges, ovarian tumor, recurrent spontaneous abortion, implantation failure after ≥ 2 fresh or frozen ET.
Contacts and Locations

Contacts
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Contact: Yasmin Magdi, PhD 00201282313979 Yas.magdi@hotmail.com

Locations
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Egypt
Al-Yasmeen Fertility and Gynecology Center Recruiting
Banhā, Egypt
Contact: Yasmin Magdi, Ph.D    00201282313979    Yas.magdi@hotmail.com   
Sponsors and Collaborators
Al-Yasmeen Fertility and Gynecology Center
Tracking Information
First Submitted Date  ICMJE June 22, 2019
First Posted Date  ICMJE June 26, 2019
Last Update Posted Date January 28, 2020
Actual Study Start Date  ICMJE July 30, 2019
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2019) 		Livebirth rate [ Time Frame: 32 weeks ]
The proportion of women in the population who had at least one live baby.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2019)
  • Pregnancy rate [ Time Frame: 2 weeks ]
    Positive pregnancy test at two weeks +/- three days after embryo transfer
  • Clinical pregnancy rate [ Time Frame: 6-8 weeks ]
    The presence of at least one fetal heartbeat at ultrasound between six and eight weeks of gestation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Freeze-all Policy in Poor Responders
Official Title  ICMJE Fresh Versus Frozen Embryos for Infertility in the Poor Responders as Defined by the Bologna Criteria
Brief Summary To compare the effects of fresh embryo transfers (ET) and elective frozen-thawed embryo transfer cycles in poor ovarian responders.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
Blinding of the allocated intervention is not possible.
Primary Purpose: Other
Condition  ICMJE Infertility, Female
Intervention  ICMJE Other: Freeze-all policy
A policy of freezing all the embryos followed by subsequent thawed frozen embryo transfer
Study Arms  ICMJE
  • Experimental: Freeze-all
    Good quality embryos (either day 3 or 5) will be frozen and subsequent frozen embryo transfer will be arranged within three months of the egg retrival.
    Intervention: Other: Freeze-all policy
  • No Intervention: Fresh embryo transfer
    Women will undergo fresh embryo transfer at the cleavage (day 3) or blastocyst stage (day 5).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 25, 2019) 		178
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients that fulfill the Bologna criteria [at least 2 of the following 3 features must be present: (i) advanced maternal age or any other risk factor for POR; (ii) a previous POR; and (iii) an abnormal ovarian reserve test (ORT)]
  • if the progesterone serum level was ≤1.5 ng/mL on the trigger day.
  • body mass index 18-32 kg/m2
  • Both partners are able to provide written informed consent.
  • At least 1 good quality embryo on day 3 after egg collection on day 3 according to the Istanbul consensus (7-8 cells; with symmetric blastomeres and <10% fragmentation by volume).
  • Endometrial thickness ≥8 mm on trigger day.
  • a normal uterine cavity on ultrasound.
  • IVF/ICSI with only fresh semen

Exclusion Criteria:

  • Pre-implantation genetic testing is being planned.
  • if they had severe endometriosis, uterine pathology (myomas, adenomyosis, endocrinopathies, adhesions, acquired or congenital abnormalities), untreated tubal hydrosalpinges, ovarian tumor, recurrent spontaneous abortion, implantation failure after ≥ 2 fresh or frozen ET.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yasmin Magdi, PhD 00201282313979 Yas.magdi@hotmail.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03999541
Other Study ID Numbers  ICMJE #0014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Yasmin Magdi, Al-Yasmeen Fertility and Gynecology Center
Study Sponsor  ICMJE Al-Yasmeen Fertility and Gynecology Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Al-Yasmeen Fertility and Gynecology Center
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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