IVFNCT06251596
What is the Impact of Frozen Embryo Transfer Protocol, on Endometrial Compaction
An observational study of IVF, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
This study aims to evaluate endometrial thickness on the day of the frozen embryo transfer, compared to endometrial thickness on the last day of assessment of the endometrium before exposure to progesterone in respect to the protocols used for endometrial preparation Read more about this study
- Who is it for?
- Ages 20 to 44 years, women only
- Conditions the study is for
- IVF
- How many people
- 247 participants
- Where
- 1 siteIsrael
- Study dates
- 25 Jan 2021to 31 Dec 2023
- Phase
- Observational
- 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 20 to 44 years
- Women only
- Adult
Study population: 250 IVF patients undergoing the return of frozen embryos
Who may be able to join
- -
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate endometrial thickness on the day of the frozen embryo transfer, compared to endometrial thickness on the last day of assessment of the endometrium before exposure to progesterone in respect to the protocols used for endometrial preparation
Read the detailed description
247 FET cycles were included in the study. Records of all patients and their cryopreservation embryos were analyzed. Data collection included baseline parameters of age, BMI (kg/m2), type of infertility, parity, lifestyles, and cause of infertility, as well as treatment parameters, including number of embryos transferred, embryo quality and pregnancy outcomes.
To reflect the broad range of patients typically encountered in clinical practice, no inclusion/exclusion criteria were applied regarding baseline characteristics.
- Conditions
- IVF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with ovulatory cycles | Patients with ovulatory cycles | |
| Patients with artificial cycles | Patients with artificial cycles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial compaction in each group.
Endometrial compaction in each group.
Measured: 5 years
Secondary outcomes (1)
Implantation and pregnancy rates in each group
Implantation and pregnancy rates in each group
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start25 Jan 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Einat Shalom Paz, PROF, Principal investigator, Israel Hillel Yaffe medical centerAnna Turetzky Oved, Nurse, Study chair, Israel Hillel Yaffe medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251596
- Sponsor's protocol ID
- 0202-20-HYMC
- Status last verified
- Feb 2023
- First submitted
- 1 Feb 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Impact of Frozen Embryo Transfer Protocol, on Endometrial Compaction
- ClinicalTrials.gov ID
- NCT06251596
- Acronym / sponsor ID
- 0202-20-HYMC
- Conditions
- IVF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 9 Feb 2024 (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.
This study aims to evaluate endometrial thickness on the day of the frozen embryo transfer, compared to endometrial thickness on the last day of assessment of the endometrium before exposure to progesterone in respect to the protocols used for endometrial preparation
Detailed description
247 FET cycles were included in the study. Records of all patients and their cryopreservation embryos were analyzed. Data collection included baseline parameters of age, BMI (kg/m2), type of infertility, parity, lifestyles, and cause of infertility, as well as treatment parameters, including number of embryos transferred, embryo quality and pregnancy outcomes.
To reflect the broad range of patients typically encountered in clinical practice, no inclusion/exclusion criteria were applied regarding baseline characteristics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with ovulatory cycles | – | –Patients with ovulatory cycles |
| Patients with artificial cycles | – | –Patients with artificial cycles |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- 250 IVF patients undergoing the return of frozen embryos
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Endometrial compaction in each group.
Time frame: 5 years
Endometrial compaction in each group.
1 secondary outcome
Implantation and pregnancy rates in each group
Time frame: 5 years
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 9 Feb 2024.
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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.
Einat Shalom Paz, PROF principal investigator
Israel Hillel Yaffe medical center
Anna Turetzky Oved, Nurse study chair
Israel Hillel Yaffe medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IVF, run by Hillel Yaffe 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 1 inclusion and 1 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 9 Feb 2024. 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?
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?
Endometrial compaction in each group. (time frame: 5 years). 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 9 Feb 2024.