Evaluation of the Relationship Between Air Bubbles Depth and Pregnancy Rate in ICSI Cycles
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|ClinicalTrials.gov Identifier: NCT02658695|
Recruitment Status : Unknown
Verified January 2016 by Hagar Elnashar, Ain Shams Maternity Hospital.
Recruitment status was: Recruiting
First Posted : January 20, 2016
Last Update Posted : January 22, 2016
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?
|Condition or disease|
|Good Ovarian Response Infertility History|
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||82 participants|
|Target Follow-Up Duration:||8 Weeks|
|Official Title:||Evaluation of the Relationship Between Air Bubbles Depth and Pregnancy Rate in ICSI Cycles|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||February 2016|
|Estimated Study Completion Date :||February 2016|
The distance between the fundal endometrial surface and air bubbles (air bubbles depth) <10 mm.
The distance between the fundal endometrial surface and air bubbles (air bubbles depth) >10 mm.
- biochemical pregnancy rate [ Time Frame: 14 days after ET ]rate of pregnant females by serum quantitative beta-hCG level at 14 days after ET
- clinical pregnancy rate [ Time Frame: at 6 - 8 weeks of amenorrhea ]using trans-vaginal US examination to detect the presence of fetal sac & pulsation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658695
|Contact: Ahmed Khairy Makled, M.Demail@example.com|
|Study Chair:||Gasser Elbishery, M.D||Ain Shams Maternity Hospital|