IVFNCT06583265
Impact of Endometrial Compaction on Clinical Pregnancy Rate in Frozen Embryo Transfers
An observational study of IVF, run by Ain Shams University at 1 site in Egypt.
Trial summary
To find out if the percentage of endometrial compaction is correlated to clinical pregnancy rate in down regulated frozen embryo transfer cycle. Endometrial compaction is the change in endometrial thickness between the end of the estrogen only phase and the day of embryo transfer. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- IVF
- What is being tested?
- Observational
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to Sep 2024
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Infertility patients planning for FET
Who may be able to join
- Women undergoing down regulated cycles frozen embryo transfer.
- Women at age group 20-35 years old.
- Day 5 embryos will be transferred.
Who cannot join
- Chromosomal abnormality in either partner (As this could lead to cycle cancellation).
- Uterine malformation or any intrauterine condition affecting the pregnancy outcomes of FET, such as endometrial polyps, uterine cavity adhesion, history of endometrial tuberculosis, hydrosalpinx with a reflux into uterine cavity (As the might not be candidates for IVF cycle till correction).
- Recurrent implantation failure, defined as 2 or more previous failed trials (Other confounding factors might of present which could affect the results).
- Cycles of patients with persistent endometrial thickness <7mm during treatment protocol (Due to cycled cancelation).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo
Passant Eid, MBBCH, 01119405010, emp14094@med.asu.edu.eg
About this study
To find out if the percentage of endometrial compaction is correlated to clinical pregnancy rate in down regulated frozen embryo transfer cycle. Endometrial compaction is the change in endometrial thickness between the end of the estrogen only phase and the day of embryo transfer. In concept, the compaction of the endometrium after progesterone initiation indicates that the endometrium is responsive to progesterone and could therefore be used as a proxy for endometrial receptivity predictability of FET cycle outcome
- Conditions
- IVF
- Being tested
- Observational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalDrug
To observe if endometrial compaction ≥ 5% in down regulated FET cycles increases clinical pregnancy rate.
| Study group | Role | What they receive |
|---|---|---|
| Infertility patients planning for FET | Not described Receives: Drug: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate
Clinical pregnancy rate, determined by visualizing a viable embryo within the uterine cavity by ultrasound 3-4 weeks after ET, in patients with endometrial compaction in down regulated FET cycles in comparison to non endometrial compaction.
Measured: 3-4 wks after ET
Secondary outcomes (3)
Percentage of change of endometrial thickness between the end of estrogen administration only phase and the day of embryo transfer.
Measured: 3-4 wks after ET
Chemical pregnancy rates, detected by positive hCG test in the absence of pregnancy findings on TVUS
Measured: 3-4 wks after ET
Number of estrogen administration days
Measured: 10 days before ET
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start1 Jan 2024
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
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.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583265
- Sponsor's protocol ID
- Endometrial Compaction
- Status last verified
- Jan 2024
- First submitted
- 1 Sep 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Endometrial Compaction on Clinical Pregnancy Rate in Frozen Embryo Transfers
- ClinicalTrials.gov ID
- NCT06583265
- Acronym / sponsor ID
- Endometrial Compaction
- Conditions
- IVF
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 4 Sep 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.
To find out if the percentage of endometrial compaction is correlated to clinical pregnancy rate in down regulated frozen embryo transfer cycle. Endometrial compaction is the change in endometrial thickness between the end of the estrogen only phase and the day of embryo transfer. In concept, the compaction of the endometrium after progesterone initiation indicates that the endometrium is responsive to progesterone and could therefore be used as a proxy for endometrial receptivity predictability of FET cycle outcome
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infertility patients planning for FET | – | Drug: Observational |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Infertility patients planning for FET
Key inclusion criteria (3 listed)
- Women undergoing down regulated cycles frozen embryo transfer.
- Women at age group 20-35 years old.
- Day 5 embryos will be transferred.
Key exclusion criteria (4 listed)
- Chromosomal abnormality in either partner (As this could lead to cycle cancellation).
- Uterine malformation or any intrauterine condition affecting the pregnancy outcomes of FET, such as endometrial polyps, uterine cavity adhesion, history of endometrial tuberculosis, hydrosalpinx with a reflux into uterine cavity (As the might not be candidates for IVF cycle till correction).
- Recurrent implantation failure, defined as 2 or more previous failed trials (Other confounding factors might of present which could affect the results).
- Cycles of patients with persistent endometrial thickness <7mm during treatment protocol (Due to cycled cancelation).
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 |
|---|---|---|
| ObservationalTo observe if endometrial compaction ≥ 5% in down regulated FET cycles increases clinical pregnancy rate. | Drug | Infertility patients planning for FET |
Primary outcome
clinical pregnancy rate
Time frame: 3-4 wks after ET
Clinical pregnancy rate, determined by visualizing a viable embryo within the uterine cavity by ultrasound 3-4 weeks after ET, in patients with endometrial compaction in down regulated FET cycles in comparison to non endometrial compaction.
3 secondary outcomes
Percentage of change of endometrial thickness between the end of estrogen administration only phase and the day of embryo transfer.
Time frame: 3-4 wks after ET
Chemical pregnancy rates, detected by positive hCG test in the absence of pregnancy findings on TVUS
Time frame: 3-4 wks after ET
Number of estrogen administration days
Time frame: 10 days before ET
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
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 Ain Shams University at 1 site 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 3 inclusion and 4 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 4 Sep 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical pregnancy rate (time frame: 3-4 wks after ET). 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 4 Sep 2024.