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Comparing the Ongoing Pregnancy Rate for Vitrification of Day-4 Morula With Day-5 Blast

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ClinicalTrials.gov Identifier: NCT03787901
Recruitment Status : Recruiting
First Posted : December 26, 2018
Last Update Posted : August 7, 2019
Sponsor:
Collaborators:
Al Hayat ICSI Centre of Alexandria, Egypt
Agial IVF/ICSI Unit of Alexandria, Egypt
Al Madina Fertility centre of Alexandria, Egypt
Rahem Fertility Center of Zagazig, Egypt
IbnSina IVF Centre of Sohag, Egypt
Bannon IVF Centre of Assiut, Egypt
Quena IVF Centre of Quena, Egypt
Alrahma Fertility Hospital of Sohag, Egypt
Alnada Fertility Center of Bniswaif, Egypt
Alhayat Algaded IVF Centre of Mansoura, Egypt
Ganna Fertility Hospital of Cairo, Egypt
Information provided by (Responsible Party):
Hassan Maghraby, Egyptian Foundation of Reproductive Endocrinology

Tracking Information
First Submitted Date  ICMJE December 20, 2018
First Posted Date  ICMJE December 26, 2018
Last Update Posted Date August 7, 2019
Actual Study Start Date  ICMJE January 15, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2018)
The ongoing pregnancy rate [ Time Frame: 12 weeks ]
Continued pregnancy at > gestational week 12 or more per initiated cycle
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2018)
  • Biochemical pregnancy rate [ Time Frame: 14 days ]
    positive b-hCG at ≥ 14 days following embryo transfer per initiated cycle
  • Implantation rate [ Time Frame: 12 weeks ]
    Sacs with a heartbeat on ultrasound per embryo transferred
  • Cumulative implantation rate [ Time Frame: One year ]
    Sacs with a heartbeat on ultrasound per embryo transferred within one year from randomization
  • Clinical pregnancy rate [ Time Frame: 7 weeks ]
    Sacs with a positive heartbeat on ultrasound at ≥ 7 weeks of gestation per initiated cycle
  • Cumulative clinical pregnancy rate [ Time Frame: One year ]
    Sacs with a positive heartbeat on ultrasound at ≥ 7 weeks of gestation per initiated cycle within one year from randomization
  • Cumulative ongoing pregnancy rate [ Time Frame: One year ]
    continued pregnancy after gestational week 12 per initiated cycle within one year from randomization
  • Twin pregnancy rate [ Time Frame: One year ]
    ≥ two foetuses with a heartbeat per initiated cycle
  • Embryo survival rate after thawing [ Time Frame: Five days of culture ]
    Blastocyst re-expansion for day 5 vitrified embryo after two hours and blastocyst formation on day 5 for embryo vitrified on day 4
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 Comparing the Ongoing Pregnancy Rate for Vitrification of Day-4 Morula With Day-5 Blast
Official Title  ICMJE The Ongoing Pregnancy Rate for Vitrification of Day-4 Morula and Day-5 Blastocyst
Brief Summary Comparing the vitrification at Day-4 (morula stage) with the blastocyst stage vitrification outcomes with the transfer of all day 5 after warming seems need evaluation. To the best of our knowledge, there has been no random-controlled trial conducted such comparison. Altogether, this trial is to evaluate the morula stage vitrification to blastocyst vitrification on the ongoing pregnancy rate after ICSI.
Detailed Description

Vitrification of human embryos has been a paradigm-shifting procedure for higher survival rate compared with the slow freezing protocol. The evidence is scarce to support superior results for vitrifying certain stages of preimplantation embryos. Anecdotal evidence suggests that blastocyst vitrification is more forgiving than cleavage stages. However, data obtained from the procedure of assisted shrinkage of blastocysts before vitrification show a higher survival rate, suggesting that fluid accumulation insides the blastocyst can be a barrier for cryoprotectant to reach the cells. Although reassuring, whether facilitating the cryoprotectants transfer to cells by the laser-assisted shrinkage or other modalities is completely safe remains elusive. Moreover, other claims compare between day-3 embryos vitrification and blastocyst stage, suggesting no difference exists.

One of the most critical stages in embryo development is the maternal to zygotic genome activation (MZA), which occurs at the 4 to 8 cell stages. Therefore, it seems the morula stage is still cleavage but passed the MZA. Morula in the most grading system has compaction for all or the majority of cells so if vitrified, the morula stage can bypass the earlier stage of vitrification as well as the need for the artificial shrinkage for blastocyst stage. Therefore, comparing the vitrification at Day-4 (morula stage) with the blastocyst stage vitrification outcomes with the transfer of all day 5 after warming seems need evaluation. To the best of our knowledge, there has been no random-controlled trial conducted such comparison. Altogether, this trial is to evaluate the morula stage vitrification to blastocyst vitrification on the ongoing pregnancy rate after ICSI.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Infertility
Intervention  ICMJE Other: Morula Vitrification
Evaluating the ongoing pregnancy rate following Morula vitrification compared with Blastocyst Vitrification.
Study Arms  ICMJE
  • Experimental: Morula Vitrification Arm
    Intervention: Other: Morula Vitrification
  • Active Comparator: Blastocyst Vitrification Arm
    Intervention: Other: Morula Vitrification
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: August 5, 2019)
1120
Original Estimated Enrollment  ICMJE
 (submitted: December 22, 2018)
850
Estimated Study Completion Date  ICMJE January 1, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Women age of ≥ 18 to ≤ 40
  2. BMI of ≤ 31
  3. Normal responder (≥ 12 antral follicle count (AFC) during basal ultrasound examination) or hyper responder
  4. The freeze-all groups including PCOS, OHSS, or high Progesterone at trigger day
  5. Women who have ≥ 1 year of primary or secondary infertility
  6. Tubal factor (unilateral, bilateral obstruction or salpingectomy)
  7. Fresh semen ejaculates but not frozen or surgically retrieved sperm
  8. Male factor: oligoasthenozoospermia but not globozoospermia or pinhead sperm
  9. Women who are undergoing their first or second ICSI attempts with a previously successful attempt
  10. Women who undergo only freeze-all embryo
  11. Freeze-all for poor endometrium at the fresh cycle
  12. Freeze-all due to abnormal endometrial findings such as polyp or myoma with a decision for freeze all for surgical correction.
  13. Women who have normal endometrial thickness (≥ 8) and echo-pattern at the time of progesterone start in the proposed vitrified warmed cycle

Exclusion Criteria:

  1. Women who have uncorrectable uterine pathology or abnormality including submucous myoma
  2. Women or their husbands who have abnormal karyotyping
  3. Women with a history of recurrent abortions or repeated implantation failures
  4. Women who have uncontrolled diabetes
  5. Women with diagnosed or undiagnosed liver or renal disease
  6. Women who had a history of malignancy or borderline pathology
  7. Women who will not meet the inclusion criteria
  8. Women who will refuse to participate in the study
  9. Women with endometriosis
  10. Patient undergoing PGS or PGD
  11. Surgically retrieved, frozen-thawed and pinpoint sperm or globozoospermia
  12. Adenomyosis
  13. Severe medical condition
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03787901
Other Study ID Numbers  ICMJE EFRE Vitrification Trial
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: No
Responsible Party Hassan Maghraby, Egyptian Foundation of Reproductive Endocrinology
Study Sponsor  ICMJE Egyptian Foundation of Reproductive Endocrinology
Collaborators  ICMJE
  • Al Hayat ICSI Centre of Alexandria, Egypt
  • Agial IVF/ICSI Unit of Alexandria, Egypt
  • Al Madina Fertility centre of Alexandria, Egypt
  • Rahem Fertility Center of Zagazig, Egypt
  • IbnSina IVF Centre of Sohag, Egypt
  • Bannon IVF Centre of Assiut, Egypt
  • Quena IVF Centre of Quena, Egypt
  • Alrahma Fertility Hospital of Sohag, Egypt
  • Alnada Fertility Center of Bniswaif, Egypt
  • Alhayat Algaded IVF Centre of Mansoura, Egypt
  • Ganna Fertility Hospital of Cairo, Egypt
Investigators  ICMJE Not Provided
PRS Account Egyptian Foundation of Reproductive Endocrinology
Verification Date August 2019

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