PregnancyNCT02942472
Position Of The Tip Of The Inner Catheter And Air Bubbles As Predictors Of Pregnancy During ICSI Cycles
An observational study of Pregnancy, run by Ain Shams Maternity Hospital.
Trial summary
Position of the tip of the inner catheter and air bubbles detection (at time,5min 10min)during embryo transfer influence the pregnancy rate in ICSI cycles . Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Jan 2017
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: prospective observational study
Who may be able to join
- BMI < 30 kg/ m2.
- Between 20 and 35years old.
- FSH levels on cycle day 3 of <12 mIU/mL.
- Both ovaries present deprived of morphological abnormalities and adequately visualized in Transvaginal ultrasound.
- Grade one or two embryo quality.
Who cannot join
- Hydrosalpinx.
- Intrauterine lesion.
- Patients undergoing ET after cryopreservation.
- Blood present on the catheter during the transfer procedure.
- A difficult transfer or with a suspicion of touching the fundus.
- Endometrial thickness less than 8mm.
- Known allergic reaction against one of the ingredient of the medications used during the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Position Of The Tip Of The Inner Catheter And Air Bubbles As Predictors Of Pregnancy During ICSI Cycles:Prospective Observational Study
Position of the tip of the inner catheter and air bubbles detection (at time,5min 10min)during embryo transfer influence the pregnancy rate in ICSI cycles .
Read the detailed description
The aim of this study is to assess the relationship between the position of the tip of the inner catheter, the position of the air bubbles (at time , 5 min ,10 min )after embryo transfer and pregnancy rate outcome in ICSI cycles. Most IVF teams consider not touching the endometrium and the uterine fundus with replacement of the embryos in the lumen of the endometrial cavity the most important factors for successful embryo transfer, it is highly recommended to use agents that can facilitate a smooth embryo transfer and reduce unintended stimulation of the fundus, for example the application of soft-tipped catheters, which can improve pregnancy rate.
The advantage of using the air and liquid content for catheter loading is to prevent the embryo from adhering to the wall of the catheter at the time of injection.The presence of two air bubbles on both sides of the medium that contains the embryo prevents the transfer of the embryo within the catheter and beside, in the transfer under ultrasonographic guidance, the air bubbles are often considered a marker for the embryo's position in the uterus.
- Conditions
- Pregnancy
- Keywords
- clinical pregnancy rate after embryo transfer
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate
Measured: one and half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AMR HELMY YEHIA, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942472
- Sponsor's protocol ID
- MOHEgypt
- Status last verified
- Oct 2016
- First submitted
- 21 Oct 2016
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Position Of The Tip Of The Inner Catheter And Air Bubbles As Predictors Of Pregnancy During ICSI Cycles:Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02942472
- Acronym / sponsor ID
- MOHEgypt
- Conditions
- Pregnancy
- Keywords
- clinical pregnancy rate after embryo transfer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 24 Oct 2016 (estimated)
- 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.
Position of the tip of the inner catheter and air bubbles detection (at time,5min 10min)during embryo transfer influence the pregnancy rate in ICSI cycles .
Detailed description
The aim of this study is to assess the relationship between the position of the tip of the inner catheter, the position of the air bubbles (at time , 5 min ,10 min )after embryo transfer and pregnancy rate outcome in ICSI cycles. Most IVF teams consider not touching the endometrium and the uterine fundus with replacement of the embryos in the lumen of the endometrial cavity the most important factors for successful embryo transfer, it is highly recommended to use agents that can facilitate a smooth embryo transfer and reduce unintended stimulation of the fundus, for example the application of soft-tipped catheters, which can improve pregnancy rate.
The advantage of using the air and liquid content for catheter loading is to prevent the embryo from adhering to the wall of the catheter at the time of injection.The presence of two air bubbles on both sides of the medium that contains the embryo prevents the transfer of the embryo within the catheter and beside, in the transfer under ultrasonographic guidance, the air bubbles are often considered a marker for the embryo's position in the uterus.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- prospective observational study
Key inclusion criteria (5 listed)
- BMI < 30 kg/ m2.
- Between 20 and 35years old.
- FSH levels on cycle day 3 of <12 mIU/mL.
- Both ovaries present deprived of morphological abnormalities and adequately visualized in Transvaginal ultrasound.
- Grade one or two embryo quality.
Key exclusion criteria (7 listed)
- Hydrosalpinx.
- Intrauterine lesion.
- Patients undergoing ET after cryopreservation.
- Blood present on the catheter during the transfer procedure.
- A difficult transfer or with a suspicion of touching the fundus.
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
clinical pregnancy rate
Time frame: one and half year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Ain Shams Maternity Hospital.
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 7 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 24 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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 AMR H YEHIA, MD, MRCOG (0020127900014, am_helmy77@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical pregnancy rate (time frame: one and half year). 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 24 Oct 2016.