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Mucus Removal Before Embryo Transfer

NCT ID: NCT03292770

Last Updated: 2018-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-20

Study Completion Date

2018-05-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Infertility Embryo Transfer

Keywords

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Embryo Transfer Flushing catheter Pregnancy rate Frozen Embryo Tranfer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
All included patients will be blinded of the procedure.

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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).

Group Type EXPERIMENTAL

Flushing Catheter

Intervention Type DEVICE

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

Interventions

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Flushing Catheter

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

Intervention Type DEVICE

Eligibility Criteria

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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
Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fundacion Dexeus

OTHER

Sponsor Role lead

Responsible Party

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Jorge Rodriguez-Purata

Dr. Jorge Rodriguez-Purata

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jorge Rodriguez-Purata, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Dexeus

Locations

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Hospital Universitario Dexeus

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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SMD-CAT-2017-01

Identifier Type: -

Identifier Source: org_study_id