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

Not Applicable

• Conditions: Infertility; Assisted Reproductive Technology; IVF
• Interventions: Procedure: Trial followed by transfer; Procedure: Afterload Transfer

• Registration Number: NCT03756857
• Lead Sponsor: Acibadem Kadiköy Hospital

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

Study Timeline

• Study First Submitted: 2018-11-27
• Study First Submitted QC: 2018-11-27
• Study First Posted: 2018-11-28
• Study Start: 2019-01-21
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-21
• Last Update Posted: 2021-03-23
• Primary Completion: 2021-09
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trial Followed by Transfer	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 When it appears that the actual transfer will be possible without great difficulty ,the trial catheter is withdrawn.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
Afterload transfer	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.

Primary Outcome Measures

Name	Time	Method
clinical pregnancy rate	5-6 weeks after embryo transfer	the presence of gestational sac on ultrasound

Secondary Outcome Measures

Name	Time	Method
implantation rate	3-4 weeks after embryo transfer	the number of gestational sacs divided by the number of embryos transferred

Trial Locations

Locations (1)

Acibadem Altunizade Hospital, Unit of ART; 🇹🇷 İstanbul, Turkey