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

Good Ovarian Response Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02658695
• Other study ID #: Ahmed Khairy Makled
• Status: Recruiting
• Phase: N/A
• First received: January 15, 2016
• Last updated: January 21, 2016
• Start date: April 2015
• Est. completion date: February 2016

Study information

• Verified date: January 2016
• Source: Ain Shams Maternity Hospital
• Contact: Ahmed Khairy Makled, M.D
• Phone: +201223148633
• Email: ahmedkhairy[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Observational [Patient Registry]

Clinical 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Good Ovarian Response
• Infertility History

Locations

Country	Name	City	State
Egypt	Ain Shams maternity hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	biochemical pregnancy rate	rate of pregnant females by serum quantitative beta-hCG level at 14 days after ET	14 days after ET	Yes
Secondary	clinical pregnancy rate	using trans-vaginal US examination to detect the presence of fetal sac & pulsation.	at 6 - 8 weeks of amenorrhea	Yes