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Evaluation of the Relationship Between Air Bubbles Depth and Pregnancy Rate in ICSI Cycles

Evaluation of the Relationship Between Air Bubbles Depth and Pregnancy Rate in ICSI Cycles

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02658695
Enrollment
82
Registered
2016-01-20
Start date
2015-04-30
Completion date
2016-02-29
Last updated
2016-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Good Ovarian Response, Infertility History

Keywords

ICSI, embryo transfer, air bubbles depth

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?

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.

Interventions

None listed

Sponsors

Ain Shams Maternity Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
biochemical pregnancy rate14 days after ETrate of pregnant females by serum quantitative beta-hCG level at 14 days after ET

Secondary

MeasureTime frameDescription
clinical pregnancy rateat 6 - 8 weeks of amenorrheausing trans-vaginal US examination to detect the presence of fetal sac & pulsation.

Countries

Egypt

Contacts

Primary ContactAhmed Khairy Makled, M.D
ahmedkhairy@yahoo.com+201223148633

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026