Does the Embryo Transfer Technique Affect the Success of in Vitro Fertilization?

NCT ID: NCT03756857

Last Updated: 2021-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-21
• Study Completion Date: 2021-12-31

Brief Summary

Prospective, open, randomized, parallel, two-arm trial to compare the clinical pregnancy rate between most commonly used two embryo transfer techniques: trial followed by transfer technique and afterloading technique

Detailed Description

Eligible patients will be informed about the possibility of participating in the clinical trial in the beginning of treatment and on the day ET, a signed consent form will be collected from those recipients who confirmed their participation. These patients will be randomized immediately before the ET procedure by sequentially numbered, opaque, sealed envelopes

Conditions

Infertility; Assisted Reproductive Technology; IVF

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Afterload transfer

First, an empty catheter passes to the level of the lower uterine segment under ultrasound guidance to a point where the inner catheter enters the endometrial cavity. The inner sheath is removed slowly, leaving the outer sheath just beyond the internal os. After verifying the catheter's position on the TA ultrasound scan, the physician gives the signal to the embryologist to start the embryo loading. The embryologist brings the loaded inner catheter and inserts it into the outer sheath, which is maintained in its position by the physician.

Group Type: EXPERIMENTAL

Afterload Transfer

Intervention Type: PROCEDURE

Embryo transfer is done by using "afterload transfer" method

Trial Followed by Transfer

First a trial transfer is performed using both the inner catheter and outer sheath connected together in standard configuration, just before the actual embryo transfer. It is passed up to and just through the the internal os. When it appears that the actual transfer will be possible without great difficulty ,the trial catheter is withdrawn. An embryo transfer catheter is loaded and the actual transfer is performed

Group Type: EXPERIMENTAL

Trial followed by transfer

Intervention Type: PROCEDURE

Embryo transfer is done by using "afterload transfer" method

Interventions

Afterload Transfer

Embryo transfer is done by using "afterload transfer" method

Intervention Type: PROCEDURE

Trial followed by transfer

Embryo transfer is done by using "afterload transfer" method

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Patient has given written informed consent

2. BMI 18-30 kg/m2

3. < 2 previous failed IVF trials

4. At least two good quality embryos on the day of transfer

Exclusion Criteria

1. Congenital uterine anomaly

2. Untreated endometrial polyp or fibroid distorting uterine cavity

3. Presence of hydrosalpinx 4.2 or more prior IVF trial failure

5.Moderate to severe endometriosis 6.Recurrent pregnancy loss history

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 37 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Acibadem Kadiköy Hospital

OTHER

Sponsor Role: lead

Responsible Party

deniz usal

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Acibadem Altunizade Hospital, Unit of ART

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Elif Esra UYAR, MD

Role: CONTACT

esra.uyar@acibadem.com

+902166494444

Facility Contacts

Elif Esra Uyar, MD

Role: primary

esra.uyar@acibadem.com

+902166494444

Other Identifiers

AcibademKD

Identifier Type: -

Identifier Source: org_study_id