MUCRET: Mucus Removal Before Embryo Transfer

Sponsor

Institut Universitari Dexeus (Other)

Overall Status

Completed

CT.gov ID

NCT03292770

Collaborator

(none)

1,118

Enrollment

Location

Arms

7.3

Actual Duration (Months)

153.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Despite these revolutionary changes in the laboratory, little has changed with the process of embryo transfer (ET). A study to prospectively evaluate the role of cervical mucus removal prior to embryo transfer on pregnancy rates in ART will be undertaken.

Condition or Disease	Intervention/Treatment	Phase
Infertility Embryo Transfer	Device: Flushing Catheter	N/A

Detailed Description

ET involves placing the embryo(s) obtained before assisted reproduction technology (ART) into the uterus via a catheter advanced through the cervical canal. Yet this is the final, and in some respects the most critical, process in the sequential events that encompass an ART cycle. If an embryo cannot be delivered to the uterine cavity atraumatically and in a location for optimal implantation, the steps of ovarian hyperstimulation, oocyte retrieval, embryo culture, and embryo selection will have no benefit. Contamination of the catheter with blood may be a marker for difficult ET and has also been linked to poor ET outcomes. When retrospectively assessing outcomes, Goudas et al. (1) demonstrated a clinical pregnancy rate of 50% with no blood, and this rate fell by half when a small amount of blood was noted on the catheter tip. Pregnancy rates fell even further, to 10%, when there was a significant amount of blood (1). Similarly, in a preliminary study, blood or mucus on the tip was associated with a significantly lower pregnancy outcome (2). Blood and mucus were associated with an increased risk for unsuccessful transfers with odds ratios of 1.9 and 1.8, respectively. Although all these data suggest a possible role of cervical mucus in embryo transfer, there is no clinical evidence on the effect of removal of cervical mucus on the outcome of IVF/ICSI. In view of this uncertainty, a study to prospectively evaluate the role of cervical mucus removal prior to embryo transfer on pregnancy rates in ART will be undertaken. It is hypothesized that removal of cervical mucus will achieve higher clinical pregnancy rates.

Study Design

Study Type:

Interventional

Actual Enrollment :

1118 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

All participants will be randomized by an intention to treat approach. All other components of the IVF/ICSI cycle including stimulation medications, monitoring protocols, etc. will be at the discretion of the participant's primary physician; while this information will be documented it will not constitute criteria for enrolment. The group allocation will take place the day of the embryo transfer. The clinician will randomize all included patients into one of the two study groups using an open computer-generated list.All participants will be randomized by an intention to treat approach. All other components of the IVF/ICSI cycle including stimulation medications, monitoring protocols, etc. will be at the discretion of the participant's primary physician; while this information will be documented it will not constitute criteria for enrolment. The group allocation will take place the day of the embryo transfer. The clinician will randomize all included patients into one of the two study groups using an open computer-generated list.

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

All included patients will be blinded of the procedure.

Primary Purpose:

Treatment

Official Title:

EFFICACY STUDY OF THE UTILIZATION OF A FLUSHING CATHETER FOR REMOVAL OF CERVICAL MUCUS BEFORE AN EMBRYO TRANSFER: A RANDOMIZED PILOT CONTROLLED TRIAL

Actual Study Start Date :

Oct 20, 2017

Actual Primary Completion Date :

May 30, 2018

Actual Study Completion Date :

May 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Group Embryo transfer will be performed as per clinic's routine protocol, where cervical mucus is gently removed with a cotton swab. No manipulation of the cervical canal is executed.
Experimental: Flushing Group A catheter will be used to perform a flushing of the cervical canal with culture media. The Flushing Catheter has a flared proximal end that is designed to affix to a standard Luer slip syringe and a pre-curved distal closed end, with a biseled opening on the side, 2mm from the tip, in which liquid flushes towards the outside of the cervical canal. Device: Cook Flushing Catheter J-IUIC-352200 (3.5fr 20cm flushing catheter with positioner closed end) (CEE approval).	Device: Flushing Catheter A catheter will be used to performed a flushing of the cervical canal with culture media.

Arm

Intervention/Treatment

No Intervention: Control Group

Embryo transfer will be performed as per clinic's routine protocol, where cervical mucus is gently removed with a cotton swab. No manipulation of the cervical canal is executed.

Experimental: Flushing Group

A catheter will be used to perform a flushing of the cervical canal with culture media. The Flushing Catheter has a flared proximal end that is designed to affix to a standard Luer slip syringe and a pre-curved distal closed end, with a biseled opening on the side, 2mm from the tip, in which liquid flushes towards the outside of the cervical canal. Device: Cook Flushing Catheter J-IUIC-352200 (3.5fr 20cm flushing catheter with positioner closed end) (CEE approval).

Device: Flushing Catheter

A catheter will be used to performed a flushing of the cervical canal with culture media.

Outcome Measures

Primary Outcome Measures

Clinical Pregnancy Rate [20 days after embryo transfer]
Defined as the proportion of patients with a gestational sac seen 20 days after embryo transfer

Secondary Outcome Measures

Biochemical Pregnancy Rate [9 days after embryo transfer]
Defined as the proportion of patients with ≥25 mIU/L of serum βhCG 9 days after embryo transfer
Early Pregnancy Loss Rate [20 days after embryo transfer]
Defined as the proportion of patients with a pregnancy loss following a positive pregnancy test and/or a detectable gestational sac

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

IVF or OD patients with supernumerary embryos (oocyte's age will be considered as patient's age).
Normal transvaginal ultrasound at screening, without evidence of clinically significant abnormality consistent with finding adequate for ART with respect to uterus and adnexa
Single embryo transfer
Embryo transfer at the blastocyst stage
Embryo with a morphological classification of ≥3BB

Exclusion Criteria:

Preimplantation genetic diagnosis and/or screening

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Dexeus	Barcelona		Spain	08022

Sponsors and Collaborators

Institut Universitari Dexeus

Investigators

Principal Investigator: Jorge Rodriguez-Purata, MD, Hospital Universitario Dexeus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jorge Rodriguez-Purata, Dr. Jorge Rodriguez-Purata, Institut Universitari Dexeus

ClinicalTrials.gov Identifier:

NCT03292770

Other Study ID Numbers:

SMD-CAT-2017-01

First Posted:

Sep 26, 2017

Last Update Posted:

May 31, 2018

Last Verified:

May 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

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

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

Keywords provided by Jorge Rodriguez-Purata, Dr. Jorge Rodriguez-Purata, Institut Universitari Dexeus

Embryo Transfer

Flushing catheter

Pregnancy rate

Frozen Embryo Tranfer

Additional relevant MeSH terms:

Infertility

Study Results

No Results Posted as of May 31, 2018