ARTNCT03833869
Assisted Hatching in Frozen Blastocysts
A study testing Assisted hatching in people with ART, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
The current study aims to assess the effect of assisted hatching on the implantation rate of frozen blastocytes. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- ART
- What is being tested?
- Assisted hatching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2019to Mar 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 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- In-vitro fertilization patients at the investigators' institution, intended to undergo a transfer of a frozen five-day embryo (blastocyte)
- 18 to 39 years old
- First to third treatment cycle
- Patient has previously had a maximum of four embryos transferred.
Who cannot join
- Over 40 years old
- Congenital or acquired uterine malformations
- Hydrosalpinx
- Chronic autoimmune diseases
- Embryo intended to be undergo preimplantation genetic diagnosis
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Edith Wolfson Medical Center
Holon
Hadas Ganer Herman, MD
About this study
Official title: The Effect of Assisted Hatching on Implantation Rate in Frozen Blastocyst Transfer - a Prospective Randomized Controlled Study
The current study aims to assess the effect of assisted hatching on the implantation rate of frozen blastocytes.
Read the detailed description
The Zona Pellucida protects the ovum from the penetration of multiple sperm, and from mechanical and physiological damage until the fertilized ovum reaches the uterus. Subsequently, spontaneous hatching occurs, and enables the embryo to attach to the endometrium. The technique of assisted hatching was originally investigated as a means to improve implantation in cases of zona hardening, and is commonly performed in 3-day embryos. In the current study, the investigators aim to investigate the effect of assisted hatching on 5-day frozen embryos.
- Conditions
- ART
- Being tested
- Assisted hatching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assisted hatchingProcedure or surgery
Controlled hatching of the zona pellucida in the laboratory prior to embryo transfer
| Study group | Role | What they receive |
|---|---|---|
| Assisted hatching | Experimental | Five-day frozen embryos will undergo assisted hatching prior to embryo transfer Receives: Procedure: Assisted hatching |
| Control | No intervention | Five-day frozen embryos will not undergo any additional procedures prior to embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation rate
Number of gestational sacs demonstrated on ultrasound divided by the number of embryos transferred (expressed as percentage)
Measured: Five to six weeks following embryo transfer
Secondary outcomes (2)
Chemical pregnancy
Increase and subsequent decrease in beta HCG levels with no evidence of gestational sac on ultrasound
Measured: Five to six weeks following embryo transfer
Early spontaneous abortion
Spontaneous abortion of pregnancy during the first trimester of pregnancy
Measured: Up to 15 weeks from embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start1 Mar 2019
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARTStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hadas Ganer Herman, Wolfson Medical Center
- Investigators
- Hadas Ganer Herman, MD, Principal investigator, Edith Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833869
- Sponsor's protocol ID
- 0020-19-WOMC
- Status last verified
- Feb 2019
- First submitted
- 6 Feb 2019
- Last updated
- 11 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Assisted Hatching on Implantation Rate in Frozen Blastocyst Transfer - a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03833869
- Acronym / sponsor ID
- 0020-19-WOMC
- Conditions
- ART
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 7 Feb 2019 (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 current study aims to assess the effect of assisted hatching on the implantation rate of frozen blastocytes.
Detailed description
The Zona Pellucida protects the ovum from the penetration of multiple sperm, and from mechanical and physiological damage until the fertilized ovum reaches the uterus. Subsequently, spontaneous hatching occurs, and enables the embryo to attach to the endometrium. The technique of assisted hatching was originally investigated as a means to improve implantation in cases of zona hardening, and is commonly performed in 3-day embryos. In the current study, the investigators aim to investigate the effect of assisted hatching on 5-day frozen embryos.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assisted hatching | Experimental | Procedure: Assisted hatchingFive-day frozen embryos will undergo assisted hatching prior to embryo transfer |
| Control | No intervention | –Five-day frozen embryos will not undergo any additional procedures prior to embryo transfer |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- In-vitro fertilization patients at the investigators' institution, intended to undergo a transfer of a frozen five-day embryo (blastocyte)
- 18 to 39 years old
- First to third treatment cycle
- Patient has previously had a maximum of four embryos transferred.
Key exclusion criteria (5 listed)
- Over 40 years old
- Congenital or acquired uterine malformations
- Hydrosalpinx
- Chronic autoimmune diseases
- Embryo intended to be undergo preimplantation genetic diagnosis
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 |
|---|---|---|
| Assisted hatchingControlled hatching of the zona pellucida in the laboratory prior to embryo transfer | Procedure or surgery | Assisted hatching |
Primary outcome
Implantation rate
Time frame: Five to six weeks following embryo transfer
Number of gestational sacs demonstrated on ultrasound divided by the number of embryos transferred (expressed as percentage)
2 secondary outcomes
Chemical pregnancy
Time frame: Five to six weeks following embryo transfer
Early spontaneous abortion
Time frame: Up to 15 weeks from embryo transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
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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.
Hadas Ganer Herman, MD principal investigator
Edith Wolfson Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assisted hatching in people with ART, run by Wolfson Medical Center at 1 site in Israel.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 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 1 site in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hadas Ganer Herman, MD (9720526206696, hadassganer@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implantation rate (time frame: Five to six weeks following embryo transfer). 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 11 Jun 2019; AzTrials last refreshed its copy on 31 Oct 2026.