Fertility IssuesNCT06021886
CS Scar Impact on ART Outcomes
An observational study of Fertility Issues, run by HealthPlus Fertility Center at 1 site in United Arab Emirates.
Trial summary
CS scar impact on ART outcomes, Retrospective Cohort Study IVF outcome can be affected by the presence of caesarean section scar with or without defect in different ways Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Fertility Issues
- How many people
- 510 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 15 Jun 2023to 1 Jan 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 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: All women who underwent an embryo transfer with a Euploid embryo between 2005 and 2022, who meet the inclusion criteria will be included in the study. To compare the success rates and outcomes of pregnancies of frozen embryo transfer for euploid embryos in patients without caesarean section, and who had caesarean section (with or without a NICHE) after euploid embryo transfer.
Who may be able to join
- Age 25-40 years old.
- Euploid embryo transfer.
- Medically free
- BMI less tha 30 kg/m2
- Hormone therapy preparation for FET.
Who cannot join
- Exclusion criteria
- Previous uterine scar other than cesarean section.
- Congenital uterine abnormalities
- Presence of intrauterine lesions e.g., polyp, fibroid,
- Endometriosis or adenomyosis
- Hydrosalpinx, Chronic endometritis
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
HealthPlus fertility Centre
Abu Dhabi
HealthPLus Dr Ahmed Al Bohoty, consultant, 050406730, ahmed.bohoty@hplus.ae
Waleed Sayed, consultant, 0506638001, walid.sayed@hplus.ae
About this study
CS scar impact on ART outcomes, Retrospective Cohort Study IVF outcome can be affected by the presence of caesarean section scar with or without defect in different ways
Read the detailed description
CS scar impact on ART outcomes, Retrospective Cohort Study IVF outcome can be affected by the presence of caesarean section scar with or without defect in different ways; increase difficulty of embryo transfer, presence intrauterine fluid at the time of transfer can affect the chances of embryo implantation and increase the rate of spontaneous miscarriages To compare the success rates and outcomes of pregnancies of frozen embryo transfer for euploid embryos in patients without caesarean section, and who had caesarean section (with or without a NICHE) after euploid embryo transfer. Does CS scar and CS scar defect affect IVF outcome? All women who underwent an embryo transfer with a Euploid embryo between 2015 and 2022, who meet the inclusion criteria will be included in the study.
- Inclusion Criteria: Age 25-40 years old. Euploid embryo transfer. Medically free BMI less tha 30 kg/m2 Hormone therapy preparation for FET.
- Exclusion criteria Previous uterine scar other than cesarean section. Congenital uterine abnormalities Presence of intrauterine lesions e.g., polyp, fibroid, Endometriosis or adenomyosis Hydrosalpinx, Chronic endometritis
- Primary outcome: Clinical pregnancy rate, defined as a pregnancy with a detectable heart rate at 7 weeks of gestation or beyond.
- Secondary outcomes : Early pregnancy complications Ectopic pregnancy or Miscarriage. Caesarean section scar dehiscence or
- Conditions
- Fertility Issues
- Keywords
- CS Scar Impact on ART Outcomes
- Medical subject headings
- Infertility
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 |
|---|---|---|
| patient without scar | history of euploid embryo transfer | |
| patient with cs scar no Niche | history of euploid embryo transfer | |
| patient with cs scar with niche | history of euploid embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
CS scar impact on ART outcomes, Retrospective Cohort Study
Clinical pregnancy rate
Measured: 2015 to 2022,
Secondary outcomes (1)
ART outcomes
Early pregnancy complications:
Ectopic pregnancy or Miscarriage.
Caesarean section scar dehiscence or rupture.
Presence of intrauterine fluid accumulation at the time of ET.
Endometrial thickness at the time of ET.
Live birth.
Measured: 2015 to 2022,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start15 Jun 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility IssuesStudies 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
- Retrospective
- Enrolment
- 510 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HealthPlus Fertility Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Elsayed Hassan Hamed Elbohoty, HealthPlus Fertility Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021886
- Sponsor's protocol ID
- REC/2023/P38
- Status last verified
- Nov 2023
- First submitted
- 21 Jun 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CS Scar Impact on ART Outcomes
- ClinicalTrials.gov ID
- NCT06021886
- Acronym / sponsor ID
- REC/2023/P38
- Conditions
- Fertility Issues
- Keywords
- CS Scar Impact on ART Outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 510 participants (estimated)
- Lead sponsor
- HealthPlus Fertility CenterUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 1 Sep 2023 (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.
CS scar impact on ART outcomes, Retrospective Cohort Study IVF outcome can be affected by the presence of caesarean section scar with or without defect in different ways
Detailed description
CS scar impact on ART outcomes, Retrospective Cohort Study IVF outcome can be affected by the presence of caesarean section scar with or without defect in different ways; increase difficulty of embryo transfer, presence intrauterine fluid at the time of transfer can affect the chances of embryo implantation and increase the rate of spontaneous miscarriages To compare the success rates and outcomes of pregnancies of frozen embryo transfer for euploid embryos in patients without caesarean section, and who had caesarean section (with or without a NICHE) after euploid embryo transfer. Does CS scar and CS scar defect affect IVF outcome? All women who underwent an embryo transfer with a Euploid embryo between 2015 and 2022, who meet the inclusion criteria will be included in the study.
- Inclusion Criteria: Age 25-40 years old. Euploid embryo transfer. Medically free BMI less tha 30 kg/m2 Hormone therapy preparation for FET.
- Exclusion criteria Previous uterine scar other than cesarean section. Congenital uterine abnormalities Presence of intrauterine lesions e.g., polyp, fibroid, Endometriosis or adenomyosis Hydrosalpinx, Chronic endometritis
- Primary outcome: Clinical pregnancy rate, defined as a pregnancy with a detectable heart rate at 7 weeks of gestation or beyond.
- Secondary outcomes : Early pregnancy complications Ectopic pregnancy or Miscarriage. Caesarean section scar dehiscence or
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patient without scar | – | –history of euploid embryo transfer |
| patient with cs scar no Niche | – | –history of euploid embryo transfer |
| patient with cs scar with niche | – | –history of euploid embryo transfer |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All women who underwent an embryo transfer with a Euploid embryo between 2005 and 2022, who meet the inclusion criteria will be included in the study. To compare the success rates and outcomes of pregnancies of frozen embryo transfer for euploid embryos in patients without caesarean section, and who had caesarean section (with or without a NICHE) after euploid embryo transfer.
Key inclusion criteria (5 listed)
- Age 25-40 years old.
- Euploid embryo transfer.
- Medically free
- BMI less tha 30 kg/m2
- Hormone therapy preparation for FET.
Key exclusion criteria (6 listed)
- Exclusion criteria
- Previous uterine scar other than cesarean section.
- Congenital uterine abnormalities
- Presence of intrauterine lesions e.g., polyp, fibroid,
- Endometriosis or adenomyosis
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
CS scar impact on ART outcomes, Retrospective Cohort Study
Time frame: 2015 to 2022,
Clinical pregnancy rate
1 secondary outcome
ART outcomes
Time frame: 2015 to 2022,
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
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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 Fertility Issues, run by HealthPlus Fertility Center at 1 site in United Arab Emirates.
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 5 inclusion and 6 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 21 Nov 2023. 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 United Arab Emirates. 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?
CS scar impact on ART outcomes, Retrospective Cohort Study (time frame: 2015 to 2022,). 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 21 Nov 2023.