Infertility, FemaleNCT04962789
Endometrial Compaction in Assissted Reproduction
An observational study of Infertility, Female, run by Assiut University at 1 site in Egypt.
Trial summary
To record the dynamic change of endometrial thickness (Day of embryo transfer Versus. Day of ovulation trigger administration in case of fresh cycles or end of estrogen phase in frozen cycles), and to investigate the impact of endometrial thickness change on pregnancy outcomes Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- transvaginal ultrasound on the uterus
- How many people
- 145 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2021to 1 Oct 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women undergoing IVF/ICSI.
Who may be able to join
- • Infertile women aged 18 years to 40 years undergoing IVF/ ICSI for any indication.
Who cannot join
- • History of recurrent pregnancy loss (≥ 2 spontaneous abortions) and/or history of recurrent (≥ 2) ICSI failure after embryo transfer.
- Uterine malformations.
- Uncorrected hydrosalpinx.
- Intrauterine conditions affecting pregnancy outcomes such as ( intrauterine adhesions, fibroids, polyps).
- Any previous hysteroscopic surgery eg. Metroplasty or hysteroscopic myomectomy or uterine surgeries involving the endometrium eg. myomectomy during which uterine cavity was opened.
- History suggesting endometritis.
- Use of hCG for endometrial preparation or luteal phase support.
- Poor quality embryos( according to Istanbul consensus workshop on embryo assessment )
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Women Health Hospital
Asyut, 71511
Ayman Askar, demonstrator, 00201019014640, aaaaskar@yahoo.com
About this study
Official title: The Impact of Endometrial Compaction on Ongoing Pregnancy Rate in Assisted Reproductive Technology Cycles : Prospective Cohort Study
To record the dynamic change of endometrial thickness (Day of embryo transfer Versus. Day of ovulation trigger administration in case of fresh cycles or end of estrogen phase in frozen cycles), and to investigate the impact of endometrial thickness change on pregnancy outcomes
Read the detailed description
Clinical pregnancy rate in IVF cycles depends on embryo quality and endometrial receptivity . It is challenging to assess endometrial receptivity. Measuring endometrial thickness by ultrasonography is a simple , noninvasive and accurate method to do so. Many studies have implicated endometrial thickness and pattern as prognostic parameters for successful outcomes in IVF-ET.
Some studies have suggested a minimal thickness for a successful pregnancy to occur, while others have reported adverse effects of increased endometrial thickness above which pregnancy is unlikely to occur.
Now there is a novel hypothesis that not only the initial endometrial thickness can affect implantation rate and clinical pregnancy rate ,but also the decrease in endometrial thickness in the time interval between the ovulation triggering and the embryo transfer or what is called endometrial compaction increases the implantation and clinical pregnancy rate
- Conditions
- Infertility, Female
- Being tested
- transvaginal ultrasound on the uterus
- Keywords
- infertility, IVF , ICSI, endometrium, compaction
- Medical subject headings
- Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transvaginal ultrasound on the uterusDiagnostic test
Transvaginal ultrasound measurement to record endometrial thickness 2 times in each cycle:
In case of fresh cycles: 1)Day of ovulation triggering 2)Day of embryo transfer In case of frozen thawed cycles : 1)End of estrogen phase 2)Day of embryo transfer
| Study group | Role | What they receive |
|---|---|---|
| with compaction | those whose endometrial thickness is calculated to decrease by the time of embryo transfer compared with the thickness at the day of ovulation trigger, analyzed according to the degree of compaction, i.e., 5%, 10%, 15%, or 20% decrease thickness Receives: Diagnostic Test: transvaginal ultrasound on the uterus | |
| without compaction | those who had an increase in their endometrial thickness or whose thickness decreased less than 5% Receives: Diagnostic Test: transvaginal ultrasound on the uterus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
rate of ongoing pregnancy in patients who have endometrial compaction
Measured: 12 weeks after embryo transfer if hCG tested positive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start20 Aug 2021
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Ahmad Abdelraof Ahmad Askar, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962789
- Sponsor's protocol ID
- EC
- Status last verified
- May 2022
- First submitted
- 10 Jul 2021
- Last updated
- 13 May 2022
- 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 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Endometrial Compaction on Ongoing Pregnancy Rate in Assisted Reproductive Technology Cycles : Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04962789
- Acronym / sponsor ID
- EC
- Conditions
- Infertility, Female
- Keywords
- infertility, IVF , ICSI, endometrium, compaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 15 Jul 2021 (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 record the dynamic change of endometrial thickness (Day of embryo transfer Versus. Day of ovulation trigger administration in case of fresh cycles or end of estrogen phase in frozen cycles), and to investigate the impact of endometrial thickness change on pregnancy outcomes
Detailed description
Clinical pregnancy rate in IVF cycles depends on embryo quality and endometrial receptivity . It is challenging to assess endometrial receptivity. Measuring endometrial thickness by ultrasonography is a simple , noninvasive and accurate method to do so. Many studies have implicated endometrial thickness and pattern as prognostic parameters for successful outcomes in IVF-ET.
Some studies have suggested a minimal thickness for a successful pregnancy to occur, while others have reported adverse effects of increased endometrial thickness above which pregnancy is unlikely to occur.
Now there is a novel hypothesis that not only the initial endometrial thickness can affect implantation rate and clinical pregnancy rate ,but also the decrease in endometrial thickness in the time interval between the ovulation triggering and the embryo transfer or what is called endometrial compaction increases the implantation and clinical pregnancy rate
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with compaction | – | Diagnostic Test: transvaginal ultrasound on the uterusthose whose endometrial thickness is calculated to decrease by the time of embryo transfer compared with the thickness at the day of ovulation trigger, analyzed according to the degree of compaction, i.e., 5%, 10%, 15%, or 20% decrease thickness |
| without compaction | – | Diagnostic Test: transvaginal ultrasound on the uterusthose who had an increase in their endometrial thickness or whose thickness decreased less than 5% |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women undergoing IVF/ICSI.
Key inclusion criteria (1 listed)
- • Infertile women aged 18 years to 40 years undergoing IVF/ ICSI for any indication.
Key exclusion criteria (8 listed)
- • History of recurrent pregnancy loss (≥ 2 spontaneous abortions) and/or history of recurrent (≥ 2) ICSI failure after embryo transfer.
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 |
|---|---|---|
| transvaginal ultrasound on the uterusTransvaginal ultrasound measurement to record endometrial thickness 2 times in each cycle: In case of fresh cycles: 1)Day of ovulation triggering 2)Day of embryo transfer In case of frozen thawed cycles : 1)End of estrogen phase 2)Day of embryo transfer | Diagnostic test | with compaction, without compaction |
Primary outcome
Ongoing pregnancy rate
Time frame: 12 weeks after embryo transfer if hCG tested positive
rate of ongoing pregnancy in patients who have endometrial compaction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Infertility, Female
RecruitingObservational study
Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)
Infertility
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
RecruitingObservational study
Biorepository in Participants Who Undergo OTC for Gonadotoxic Therapy
Acute Ovarian Failure, Infertility
Not yet recruitingObservational study
Linzagolix in Adenomyosis and Recurrent Implantation Failure
Adenomyosis of Uterus, Implantation Failure
Recruiting
225 IU Versus 300 IU Starting FSH Dose in PPOS for Good-Prognosis Women
Infertility (IVF Patients), Infertility Assisted Reproductive Technology
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 Infertility, Female, run by Assiut 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 1 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: status not confirmed, as of the sponsor's last update on 13 May 2022. 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?
Contact Ayman Askar, master (0020101 901 4640, aaaaskar@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy rate (time frame: 12 weeks after embryo transfer if hCG tested positive). 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 13 May 2022.