Mucus Removal Before Embryo Transfer (MUCRET)

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

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.

Study Overview

• Status: Completed
• Conditions: Infertility; Embryo Transfer
• Intervention / Treatment: Device: Flushing Catheter

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 Type: Interventional
• Enrollment (Actual): 1118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08022
    • Hospital Universitario Dexeus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 40 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Pregnancy Rate	Defined as the proportion of patients with a gestational sac seen 20 days after embryo transfer	20 days after embryo transfer

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Institut Universitari Dexeus
• Investigators: Principal Investigator: Jorge Rodriguez-Purata, MD, Hospital Universitario Dexeus

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 20, 2017
• Primary Completion (ACTUAL): May 30, 2018
• Study Completion (ACTUAL): May 30, 2018

Study Registration Dates

• First Submitted: September 21, 2017
• First Submitted That Met QC Criteria: September 21, 2017
• First Posted (ACTUAL): September 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 31, 2018
• Last Update Submitted That Met QC Criteria: May 30, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Pregnancy rate; Embryo Transfer; Flushing catheter; Frozen Embryo Tranfer
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: SMD-CAT-2017-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No