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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
Sponsor:
Information provided by (Responsible Party):
Hagar Elnashar, Ain Shams Maternity Hospital

Study Description
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Brief 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?


Condition or disease
Good Ovarian Response Infertility History

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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 82 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. biochemical pregnancy rate [ Time Frame: 14 days after ET ]
    rate of pregnant females by serum quantitative beta-hCG level at 14 days after ET


Secondary Outcome Measures :
  1. clinical pregnancy rate [ Time Frame: at 6 - 8 weeks of amenorrhea ]
    using trans-vaginal US examination to detect the presence of fetal sac & pulsation.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Ahmed Khairy Makled, M.D +201223148633 ahmedkhairy@yahoo.com

Locations
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Egypt
Ain Shams maternity hospital Recruiting
Cairo, Egypt
Contact: Ahmed Khairy Makled, MD       ahmedkhairy@yahoo.com   
Contact: Ihab Gomaa, M.SC       ihabgomaa@yahoo.com   
Principal Investigator: Hagar Elnashar, M.B.B.Ch         
Sponsors and Collaborators
Ain Shams Maternity Hospital
Investigators
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Study Chair: Gasser Elbishery, M.D Ain Shams Maternity Hospital
More Information
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Additional Information:

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Responsible Party: Hagar Elnashar, obstetrics & gynecology resident - Ministry of health, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier: NCT02658695    
Other Study ID Numbers: Ahmed Khairy Makled
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: January 22, 2016
Last Verified: January 2016
Keywords provided by Hagar Elnashar, Ain Shams Maternity Hospital:
ICSI
embryo transfer
air bubbles depth
Additional relevant MeSH terms:
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Infertility