InfertilityNCT03787901
Comparing the Ongoing Pregnancy Rate for Vitrification of Day-4 Morula With Day-5 Blast
A study testing Morula Vitrification in people with Infertility, run by Egyptian Foundation of Reproductive Endocrinology at 4 sites in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Morula Vitrification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 4 sitesEgypt
- Study dates
- 15 Jan 2019to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women age of ≥ 18 to ≤ 40
- BMI of ≤ 31
- Normal responder (≥ 12 antral follicle count (AFC) during basal ultrasound examination) or hyper responder
- The freeze-all groups including PCOS, OHSS, or high Progesterone at trigger day
- Women who have ≥ 1 year of primary or secondary infertility
- Tubal factor (unilateral, bilateral obstruction or salpingectomy)
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- Fresh semen ejaculates but not frozen or surgically retrieved sperm
- Male factor: oligoasthenozoospermia but not globozoospermia or pinhead sperm
- Women who are undergoing their first or second ICSI attempts with a previously successful attempt
- Women who undergo only freeze-all embryo
- Freeze-all for poor endometrium at the fresh cycle
- Freeze-all due to abnormal endometrial findings such as polyp or myoma with a decision for freeze all for surgical correction.
- Women who have normal endometrial thickness (≥ 8) and echo-pattern at the time of progesterone start in the proposed vitrified warmed cycle
Who cannot join
- Women who have uncorrectable uterine pathology or abnormality including submucous myoma
- Women or their husbands who have abnormal karyotyping
- Women with a history of recurrent abortions or repeated implantation failures
- Women who have uncontrolled diabetes
- Women with diagnosed or undiagnosed liver or renal disease
- Women who had a history of malignancy or borderline pathology
Show all 13Show fewer
- Women who will not meet the inclusion criteria
- Women who will refuse to participate in the study
- Women with endometriosis
- Patient undergoing PGS or PGD
- Surgically retrieved, frozen-thawed and pinpoint sperm or globozoospermia
- Adenomyosis
- Severe medical condition
Trial locations and contacts
4 sites in 1 country.
Egypt4 sites
Agial
Alexandria, 12345
Al Hayat ICSI Centre of Alexandria
Alexandria, 12345
AlMadina IVF and ICSI Centre
Alexandria, 12345
Rahem Fertility Centre of Zagazig
Zagazig, 12345
About this study
Official title: The Ongoing Pregnancy Rate for Vitrification of Day-4 Morula and Day-5 Blastocyst
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.
Read the 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.
- Conditions
- Infertility
- Being tested
- Morula Vitrification
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morula VitrificationOther
Evaluating the ongoing pregnancy rate following Morula vitrification compared with Blastocyst Vitrification.
| Study group | Role | What they receive |
|---|---|---|
| Morula Vitrification Arm | Experimental | Not described Receives: Other: Morula Vitrification |
| Blastocyst Vitrification Arm | Active comparator | Not described Receives: Other: Morula Vitrification |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ongoing pregnancy rate
Continued pregnancy at > gestational week 12 or more per initiated cycle
Measured: 12 weeks
Secondary outcomes (8)
Biochemical pregnancy rate
positive b-hCG at ≥ 14 days following embryo transfer per initiated cycle
Measured: 14 days
Implantation rate
Sacs with a heartbeat on ultrasound per embryo transferred
Measured: 12 weeks
Cumulative implantation rate
Sacs with a heartbeat on ultrasound per embryo transferred within one year from randomization
Measured: One year
Clinical pregnancy rate
Sacs with a positive heartbeat on ultrasound at ≥ 7 weeks of gestation per initiated cycle
Measured: 7 weeks
Cumulative clinical pregnancy rate
Sacs with a positive heartbeat on ultrasound at ≥ 7 weeks of gestation per initiated cycle within one year from randomization
Measured: One year
Cumulative ongoing pregnancy rate
continued pregnancy after gestational week 12 per initiated cycle within one year from randomization
Measured: One year
Twin pregnancy rate
≥ two foetuses with a heartbeat per initiated cycle
Measured: One year
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
Measured: Five days of culture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start15 Jan 2019
- Primary completion31 May 2020
- Study completion1 Jun 2020
Why it stopped: Failed to achieve sample size due to COVID19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egyptian Foundation of Reproductive Endocrinology
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Hassan Maghraby, Egyptian Foundation of Reproductive Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787901
- Sponsor's protocol ID
- EFRE Vitrification Trial
- Status last verified
- Jun 2022
- First submitted
- 20 Dec 2018
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ongoing Pregnancy Rate for Vitrification of Day-4 Morula and Day-5 Blastocyst
- ClinicalTrials.gov ID
- NCT03787901
- Acronym / sponsor ID
- EFRE Vitrification Trial
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failed to achieve sample size due to COVID19 pandemic
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Egyptian Foundation of Reproductive EndocrinologyUniversity, hospital or other
- 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
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morula Vitrification Arm | Experimental | Other: Morula Vitrification |
| Blastocyst Vitrification Arm | Active comparator | Other: Morula Vitrification |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Women age of ≥ 18 to ≤ 40
- BMI of ≤ 31
- Normal responder (≥ 12 antral follicle count (AFC) during basal ultrasound examination) or hyper responder
- The freeze-all groups including PCOS, OHSS, or high Progesterone at trigger day
- Women who have ≥ 1 year of primary or secondary infertility
Key exclusion criteria (13 listed)
- Women who have uncorrectable uterine pathology or abnormality including submucous myoma
- Women or their husbands who have abnormal karyotyping
- Women with a history of recurrent abortions or repeated implantation failures
- Women who have uncontrolled diabetes
- Women with diagnosed or undiagnosed liver or renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morula VitrificationEvaluating the ongoing pregnancy rate following Morula vitrification compared with Blastocyst Vitrification. | Other | Blastocyst Vitrification Arm, Morula Vitrification Arm |
Primary outcome
The ongoing pregnancy rate
Time frame: 12 weeks
Continued pregnancy at > gestational week 12 or more per initiated cycle
8 secondary outcomes
Biochemical pregnancy rate
Time frame: 14 days
Implantation rate
Time frame: 12 weeks
Cumulative implantation rate
Time frame: One year
Clinical pregnancy rate
Time frame: 7 weeks
Cumulative clinical pregnancy rate
Time frame: One year
Cumulative ongoing pregnancy rate
Time frame: One year
Twin pregnancy rate
Time frame: One year
Embryo survival rate after thawing
Time frame: Five days of culture
Results and safety
The study was stopped early (reason given: Failed to achieve sample size due to COVID19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morula Vitrification in people with Infertility, run by Egyptian Foundation of Reproductive Endocrinology at 4 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Failed to achieve sample size due to COVID19 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ongoing pregnancy rate (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.