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

Infertility Clinical Trial

Official title:

The Ongoing Pregnancy Rate for Vitrification of Day-4 Morula and Day-5 Blastocyst

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03787901
• Other study ID #: EFRE Vitrification Trial
• Status: Terminated
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: June 2022
• Source: Egyptian Foundation of Reproductive Endocrinology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 53
• Est. completion date: June 1, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• Morula Vitrification
Evaluating the ongoing pregnancy rate following Morula vitrification compared with Blastocyst Vitrification.

Locations

Country	Name	City	State
Egypt	Agial	Alexandria
Egypt	Al Hayat ICSI Centre of Alexandria	Alexandria
Egypt	AlMadina IVF and ICSI Centre	Alexandria
Egypt	Rahem Fertility Centre of Zagazig	Zagazig

Sponsors (5)

Lead Sponsor	Collaborator
Egyptian Foundation of Reproductive Endocrinology	Agial IVF/ICSI Unit of Alexandria, Egypt, Al Hayat ICSI Centre of Alexandria, Egypt, Al Madina Fertility centre of Alexandria, Egypt, Rahem Fertility Center of Zagazig, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The ongoing pregnancy rate	Continued pregnancy at > gestational week 12 or more per initiated cycle	12 weeks
Secondary	Biochemical pregnancy rate	positive b-hCG at = 14 days following embryo transfer per initiated cycle	14 days
Secondary	Implantation rate	Sacs with a heartbeat on ultrasound per embryo transferred	12 weeks
Secondary	Cumulative implantation rate	Sacs with a heartbeat on ultrasound per embryo transferred within one year from randomization	One year
Secondary	Clinical pregnancy rate	Sacs with a positive heartbeat on ultrasound at = 7 weeks of gestation per initiated cycle	7 weeks
Secondary	Cumulative clinical pregnancy rate	Sacs with a positive heartbeat on ultrasound at = 7 weeks of gestation per initiated cycle within one year from randomization	One year
Secondary	Cumulative ongoing pregnancy rate	continued pregnancy after gestational week 12 per initiated cycle within one year from randomization	One year
Secondary	Twin pregnancy rate	= two foetuses with a heartbeat per initiated cycle	One year
Secondary	Embryo survival rate after thawing	Blastocyst re-expansion for day 5 vitrified embryo after two hours and blastocyst formation on day 5 for embryo vitrified on day 4	Five days of culture