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

Sponsor

Acibadem Kadiköy Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03756857

Collaborator

(none)

200

Enrollment

Location

Arms

34.3

Anticipated Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Infertility Assisted Reproductive Technology IVF	Procedure: Afterload Transfer Procedure: Trial followed by transfer	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective, open, randomized, parallel, two-arm trialProspective, open, randomized, parallel, two-arm trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison of IVF Success Rates Between Different Embryo Transfer Techniques: Afterload Technique and Trial Followed by Transfer Technique

Actual Study Start Date :

Jan 21, 2019

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Procedure: Afterload Transfer Embryo transfer is done by using "afterload transfer" method
Experimental: 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	Procedure: Trial followed by transfer Embryo transfer is done by using "afterload transfer" method

Arm

Intervention/Treatment

Experimental: 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.

Procedure: Afterload Transfer

Embryo transfer is done by using "afterload transfer" method

Experimental: 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

Procedure: Trial followed by transfer

Embryo transfer is done by using "afterload transfer" method

Outcome Measures

Primary Outcome Measures

clinical pregnancy rate [5-6 weeks after embryo transfer]
the presence of gestational sac on ultrasound

Secondary Outcome Measures

implantation rate [3-4 weeks after embryo transfer]
the number of gestational sacs divided by the number of embryos transferred

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 37 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patient has given written informed consent
BMI 18-30 kg/m2
< 2 previous failed IVF trials
At least two good quality embryos on the day of transfer

Exclusion Criteria:

Congenital uterine anomaly
Untreated endometrial polyp or fibroid distorting uterine cavity
Presence of hydrosalpinx 4.2 or more prior IVF trial failure

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Acibadem Altunizade Hospital, Unit of ART	İstanbul		Turkey	34662

Sponsors and Collaborators

Acibadem Kadiköy Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

deniz usal, Medical Doctor, Acibadem Kadiköy Hospital

ClinicalTrials.gov Identifier:

NCT03756857

Other Study ID Numbers:

AcibademKD

First Posted:

Nov 28, 2018

Last Update Posted:

Mar 23, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infertility

Study Results

No Results Posted as of Mar 23, 2021