Embryo ImplantationNCT03128970
Synchronizing Blastocyst in Frozen Embryo Transfer
A study testing synchronizing blastocysts in people with Embryo Implantation, run by Al-Yasmeen Fertility and Gynecology Center at 2 sites in Egypt.
Trial summary
The aim of the present study is to determine if implantation rate could be increased in women undergoing frozen embryo transfer cycles in case of adjusting their embryo development at hatching stage. Read more about this study
- Who is it for?
- Ages 19 to 33 years, women only
- Conditions the study is for
- Embryo Implantation
- What is being tested?
- synchronizing blastocysts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 742 participants
- Where
- 2 sitesEgypt
- Study dates
- 21 Apr 2017to 10 May 2018
- 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 19 to 33 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients who will agree to participate and assign an informed consent form
- Only blastocyst transfer FET cycles
- Patients undergoing FET after their 1st IVF or ICSI cycle with no pregnancy at the fresh transfer
- Freeze-all cycles due to OHSS
- Freeze-all cycles due to poor endometrium
- Age 19-33 at the time of randomization.
Show all 12Show fewer
- Their frozen blastocysts are 3 or less grade of expansion.
- Female with a ≥12 AFCs
- Endometrial thickness ≥ 8mm at the time of ovulation
- Women with their male partners will give only fresh semen
- Women who have no uterine abnormality by ultrasound
- BMI ≤ 31
Who cannot join
- Cycles undergoing preimplantation genetic diagnosis.
- Women who have previous two cycles of implantation failure at fresh transfer
- Women who have previous two FET failed cycles
- Any uterine pathology (myomas, adenomyosis, endocrinopathies, thrombophilia, chronic pathologies, acquired or congenital uterine abnormalities)
- Patients with severe endometriosis
- Presence of uni- or bilateral hydrosalpinx
- Recurrent pregnancy loss.
- Any medical condition that affect fertility.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Al-Yasmeen fertility and gynecology center
Banhā
Ganna Fertility and Gynecology Center
Cairo
About this study
Official title: Synchronizing Blastocyst at Hatching Stage in Frozen Embryo Transfer Cycles
The aim of the present study is to determine if implantation rate could be increased in women undergoing frozen embryo transfer cycles in case of adjusting their embryo development at hatching stage.
- Conditions
- Embryo Implantation
- Being tested
- synchronizing blastocysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
synchronizing blastocystsOther
transferring frozen/thawed a synchronized blastocysts at hatching stage into female uterus.
| Study group | Role | What they receive |
|---|---|---|
| frozen/thawed | No intervention | blastocysts with three or less grade of expansion will be thawed and then subsequently transferred into women uterus three hours post-thawing. |
| synchronized frozen/thawed hatching blastocysts | Experimental | blastocyst thawing (with three or less grade of expansion) will take place the day before embryo transfer in order to reach hatching stage Receives: Other: synchronizing blastocysts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing implantation rate
ultrasound detection of ongoing gestational sacs with heartbeats after 12 weeks of gestation per transferred embryos
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start21 Apr 2017
- Primary completion15 Jan 2018
- Study completion10 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embryo ImplantationStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 742 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Yasmeen Fertility and Gynecology Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ganna Fertility Center
- Responsible party
- Principal investigator, Yasmin Magdi, Al-Yasmeen Fertility and Gynecology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128970
- Sponsor's protocol ID
- 001-2017
- Status last verified
- Jun 2019
- First submitted
- 21 Apr 2017
- Last updated
- 27 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synchronizing Blastocyst at Hatching Stage in Frozen Embryo Transfer Cycles
- ClinicalTrials.gov ID
- NCT03128970
- Acronym / sponsor ID
- 001-2017
- Conditions
- Embryo Implantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 742 participants (actual)
- Lead sponsor
- Al-Yasmeen Fertility and Gynecology CenterUniversity, hospital or other
- Collaborators
- Ganna Fertility Center
- Study start
- 21 Apr 2017 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 10 May 2018 (actual)
- First posted
- 25 Apr 2017 (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.
The aim of the present study is to determine if implantation rate could be increased in women undergoing frozen embryo transfer cycles in case of adjusting their embryo development at hatching stage.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| frozen/thawed | No intervention | –blastocysts with three or less grade of expansion will be thawed and then subsequently transferred into women uterus three hours post-thawing. |
| synchronized frozen/thawed hatching blastocysts | Experimental | Other: synchronizing blastocystsblastocyst thawing (with three or less grade of expansion) will take place the day before embryo transfer in order to reach hatching stage |
Who may qualify
- Ages
- 19 to 33 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Patients who will agree to participate and assign an informed consent form
- Only blastocyst transfer FET cycles
- Patients undergoing FET after their 1st IVF or ICSI cycle with no pregnancy at the fresh transfer
- Freeze-all cycles due to OHSS
- Freeze-all cycles due to poor endometrium
Key exclusion criteria (8 listed)
- Cycles undergoing preimplantation genetic diagnosis.
- Women who have previous two cycles of implantation failure at fresh transfer
- Women who have previous two FET failed cycles
- Any uterine pathology (myomas, adenomyosis, endocrinopathies, thrombophilia, chronic pathologies, acquired or congenital uterine abnormalities)
- Patients with severe endometriosis
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 |
|---|---|---|
| synchronizing blastocyststransferring frozen/thawed a synchronized blastocysts at hatching stage into female uterus. | Other | synchronized frozen/thawed hatching blastocysts |
Primary outcome
Ongoing implantation rate
Time frame: 12 weeks
ultrasound detection of ongoing gestational sacs with heartbeats after 12 weeks of gestation per transferred embryos
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Individual participant dataSharing planned: Yes
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing synchronizing blastocysts in people with Embryo Implantation, run by Al-Yasmeen Fertility and Gynecology Center at 2 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 12 inclusion and 8 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: finished, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ongoing implantation 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 27 Jun 2019.