Good Ovarian ResponseNCT02658695
Evaluation of the Relationship Between Air Bubbles Depth and Pregnancy Rate in ICSI Cycles
An observational study of Good Ovarian Response and Infertility History, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
The aim of this work is to assess the effect of air bubbles localization inside the uterus on embryo transfer outcome in ICSI cycles. Is there a relationship between embryo transfer outcome and the distance between fundal endometrial surface and air bubbles assessed by trans-abdominal ultrasound? Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Good Ovarian Response, Infertility History
- How many people
- 82 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2015to Feb 2016
- How long will I take part?
- 8 Weeks
- 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 38 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Eighty two women who will undergo ICSI in assisted reproductive technology unit of Ain Shams University Hospital will be enrolled in and a written informed consent will be obtained from all participants.
Who may be able to join
- Women in reproductive period (age 18-38 years).
- Infertility due to bilateral tubal block or unexplained infertility programmed for ICSI.
- BMI < 25 kg/m².
- FSH level on cycle day 3 of < 12 mIU/mL
Who cannot join
- Previous failed ICSI or IVF attempts.
- Infertility due to male factors.
- Presence of an abnormal uterine cavity due to endometrial polyps, myomas distorting the uterine cavity, Mullerian malformations, endometrial synechiae, etc. (assessed by transvaginal US and/or hysterography).
- Patients with hydrosalpinx or pyosalpinx.
- Patients undergoing ET after cryopreservation.
- Patients with blood present on the catheter during the transfer procedure.
- Patients with difficult transfer or with suspicion of touching the fundus.
- Poor responders.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams maternity hospital
Cairo
Ahmed Khairy Makled, MD, ahmedkhairy@yahoo.com
Ihab Gomaa, M.SC, ihabgomaa@yahoo.com
About this study
The aim of this work is to assess the effect of air bubbles localization inside the uterus on embryo transfer outcome in ICSI cycles.
Is there a relationship between embryo transfer outcome and the distance between fundal endometrial surface and air bubbles assessed by trans-abdominal ultrasound?
Read the detailed description
All ET will be performed on day 3 after oocyte retrieval at the blastocyst stage by one operator under trans-abdominal US guidance performed by one physician, without any anesthesia or sedation with moderate bladder filling. Two embryos will be transferred using the same type of catheter which is Labotect embryo transfer catheter. It's a semirigid catheter that's less likely to induce endometrial trauma and uterine contractions.
The tip of the inner catheter will be placed approximately 1.5-2 cm from the fundal endometrial surface.The distance between the fundal endometrial surface and air bubbles will be measured and categorized as:
- Group 1: air bubbles depth <10 mm.
- Group 2: air bubbles depth >10 mm. The primary outcome will be biochemical pregnancy rate based on serum quantitative beta-hCG level at 14 days after ET. Secondary outcome will be clinical pregnancy rate using trans-vaginal US examination at 6 - 8 weeks of amenorrhea to detect the presence of fetal sac \& pulsation.
- Conditions
- Good Ovarian Response, Infertility History
- Keywords
- ICSI, embryo transfer, air bubbles depth
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 |
|---|---|---|
| Group 1 | The distance between the fundal endometrial surface and air bubbles (air bubbles depth) <10 mm. | |
| Group 2 | The distance between the fundal endometrial surface and air bubbles (air bubbles depth) >10 mm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
biochemical pregnancy rate
rate of pregnant females by serum quantitative beta-hCG level at 14 days after ET
Measured: 14 days after ET
Secondary outcomes (1)
clinical pregnancy rate
using trans-vaginal US examination to detect the presence of fetal sac \& pulsation.
Measured: at 6 - 8 weeks of amenorrhea
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startApr 2015
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Good Ovarian ResponseStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 82 participants (estimated)
- Target duration
- 8 Weeks
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar Elnashar, Ain Shams Maternity Hospital
- Investigators
- Gasser Elbishery, M.D, Study chair, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658695
- Sponsor's protocol ID
- Ahmed Khairy Makled
- Status last verified
- Jan 2016
- First submitted
- 15 Jan 2016
- Last updated
- 22 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Air Bubbles Depth and Pregnancy Rate in ICSI Cycles
- ClinicalTrials.gov ID
- NCT02658695
- Acronym / sponsor ID
- Ahmed Khairy Makled
- Conditions
- Good Ovarian Response, Infertility History
- Keywords
- ICSI, embryo transfer, air bubbles depth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 20 Jan 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.
The aim of this work is to assess the effect of air bubbles localization inside the uterus on embryo transfer outcome in ICSI cycles.
Is there a relationship between embryo transfer outcome and the distance between fundal endometrial surface and air bubbles assessed by trans-abdominal ultrasound?
Detailed description
All ET will be performed on day 3 after oocyte retrieval at the blastocyst stage by one operator under trans-abdominal US guidance performed by one physician, without any anesthesia or sedation with moderate bladder filling. Two embryos will be transferred using the same type of catheter which is Labotect embryo transfer catheter. It's a semirigid catheter that's less likely to induce endometrial trauma and uterine contractions.
The tip of the inner catheter will be placed approximately 1.5-2 cm from the fundal endometrial surface.The distance between the fundal endometrial surface and air bubbles will be measured and categorized as:
- Group 1: air bubbles depth <10 mm.
- Group 2: air bubbles depth >10 mm. The primary outcome will be biochemical pregnancy rate based on serum quantitative beta-hCG level at 14 days after ET. Secondary outcome will be clinical pregnancy rate using trans-vaginal US examination at 6 - 8 weeks of amenorrhea to detect the presence of fetal sac \& pulsation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 8 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –The distance between the fundal endometrial surface and air bubbles (air bubbles depth) <10 mm. |
| Group 2 | – | –The distance between the fundal endometrial surface and air bubbles (air bubbles depth) >10 mm. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Eighty two women who will undergo ICSI in assisted reproductive technology unit of Ain Shams University Hospital will be enrolled in and a written informed consent will be obtained from all participants.
Key inclusion criteria (4 listed)
- Women in reproductive period (age 18-38 years).
- Infertility due to bilateral tubal block or unexplained infertility programmed for ICSI.
- BMI < 25 kg/m².
- FSH level on cycle day 3 of < 12 mIU/mL
Key exclusion criteria (8 listed)
- Previous failed ICSI or IVF attempts.
- Infertility due to male factors.
- Presence of an abnormal uterine cavity due to endometrial polyps, myomas distorting the uterine cavity, Mullerian malformations, endometrial synechiae, etc. (assessed by transvaginal US and/or hysterography).
- Patients with hydrosalpinx or pyosalpinx.
- Patients undergoing ET after cryopreservation.
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
biochemical pregnancy rate
Time frame: 14 days after ET
rate of pregnant females by serum quantitative beta-hCG level at 14 days after ET
1 secondary outcome
clinical pregnancy rate
Time frame: at 6 - 8 weeks of amenorrhea
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2016.
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.
Gasser Elbishery, M.D study chair
Ain Shams Maternity Hospital
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 Good Ovarian Response and Infertility History, run by Ain Shams Maternity Hospital 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 4 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 22 Jan 2016. 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 Ahmed Khairy Makled, M.D (+201223148633, ahmedkhairy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biochemical pregnancy rate (time frame: 14 days 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 22 Jan 2016.