Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment Phase
Infertility Other: Morula Vitrification Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Other
Official Title: The Ongoing Pregnancy Rate for Vitrification of Day-4 Morula and Day-5 Blastocyst
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : January 1, 2020

Arm Intervention/treatment
Experimental: Morula Vitrification Arm Other: Morula Vitrification
Evaluating the ongoing pregnancy rate following Morula vitrification compared with Blastocyst Vitrification.

Active Comparator: Blastocyst Vitrification Arm Other: Morula Vitrification
Evaluating the ongoing pregnancy rate following Morula vitrification compared with Blastocyst Vitrification.




Primary Outcome Measures :
  1. The ongoing pregnancy rate [ Time Frame: 12 weeks ]
    Continued pregnancy at > gestational week 12 or more per initiated cycle


Secondary Outcome Measures :
  1. Biochemical pregnancy rate [ Time Frame: 14 days ]
    positive b-hCG at ≥ 14 days following embryo transfer per initiated cycle

  2. Implantation rate [ Time Frame: 12 weeks ]
    Sacs with a heartbeat on ultrasound per embryo transferred

  3. Cumulative implantation rate [ Time Frame: One year ]
    Sacs with a heartbeat on ultrasound per embryo transferred within one year from randomization

  4. Clinical pregnancy rate [ Time Frame: 7 weeks ]
    Sacs with a positive heartbeat on ultrasound at ≥ 7 weeks of gestation per initiated cycle

  5. 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

  6. Cumulative ongoing pregnancy rate [ Time Frame: One year ]
    continued pregnancy after gestational week 12 per initiated cycle within one year from randomization

  7. Twin pregnancy rate [ Time Frame: One year ]
    ≥ two foetuses with a heartbeat per initiated cycle

  8. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787901


Locations
Layout table for location information
Egypt
Agial Recruiting
Alexandria, Egypt, 12345
Contact: Hisham Saleh, MD    +201223152272    hishamalisaleh@gmail.com   
Principal Investigator: Hisham Saleh, MD         
Al Hayat ICSI Centre of Alexandria Recruiting
Alexandria, Egypt, 12345
Contact: Hassan Maghraby, MD    +201222137317    hassanmaghraby@gmail.com   
Contact: Dalal AlGaziry, MD    +201222137317    hassanmaghraby@gmail.com   
Principal Investigator: Hassan Maghraby, MD         
Sub-Investigator: Dalal AlGaziry, MD         
AlMadina IVF and ICSI Centre Recruiting
Alexandria, Egypt, 12345
Contact: Ashraf Aboali, MD    +201007333950    aboalimadina@yahoo.com   
Principal Investigator: Ashraf Aboali, MD         
Bannon IVF Centre Recruiting
Assiut, Egypt, 12345
Contact: Mai Emad, BSc    +201094845310    mai_emad_khedr@yahoo.com   
Principal Investigator: Mai Emad, BSc         
AlNada Fertility Centre of Baniswaif Recruiting
Baniswaif, Egypt, 12345
Contact: Mohamed A Youssif    +20114 8088826    m.a.youssef@amc.uva.nl   
Principal Investigator: Mohamed A Youssif, MD         
Sub-Investigator: Momen Abdelkhalik, MSc         
Ganaa IVF Hospital Recruiting
Cairo, Egypt
Contact: Mohamed Hady, Lab Director    +20111768111    hady_zam@yahoo.com   
Alhayat Algaded IVF Centre Recruiting
Mansoura, Egypt, 12345
Contact: Ahmed Gibreel, MD    +20 100 404 5733    ahmedfathgi@yahoo.com   
Principal Investigator: Ahmed Gibreel, MD         
Quena Fertilty Centre Recruiting
Quena, Egypt, 12345
Contact: Ahmed Mowafy, MD    +201005688230    ahm.mowafy@gmail.com   
Principal Investigator: Ahmed Mowafy, MD         
ALRahma Fertilty Hospital Recruiting
Sohag, Egypt, 12345
Contact: Mohamed y AbdelRahman    +20100 7575474    Dryahyaz@yahoo.com   
Principal Investigator: Mohamed Y AbdelRahman, MD         
IbnSina IVF Centre Recruiting
Sohag, Egypt, 12345
Contact: Mohamed Fawzy, MD    +201011122286    drfawzy001@me.com   
Principal Investigator: Mohamed Fawzy, MD         
Sub-Investigator: Mohamed Alaa, MD         
Rahem Fertility Centre of Zagazig Recruiting
Zagazig, Egypt, 12345
Contact: Eman Elgendy, MD    +2-1227491143    Eman_elgindy2013@hotmail.com   
Principal Investigator: Eman Elgendy, MD         
Sponsors and Collaborators
Egyptian Foundation of Reproductive Endocrinology
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

Layout table for additonal information
Responsible Party: Hassan Maghraby, MD, Director, Al Hayat ICSI Centre of Alexandria, Egypt, Egyptian Foundation of Reproductive Endocrinology
ClinicalTrials.gov Identifier: NCT03787901     History of Changes
Other Study ID Numbers: EFRE Vitrification Trial
First Posted: December 26, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Genital Diseases, Male
Genital Diseases, Female