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Completed

NCT Number: NCT03292770

Mucus Removal Before Embryo Transfer

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.

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Key information

Age range

Up to 40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Dexeus

Barcelona, 08022, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flushing Catheter

Device

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

Primary outcomes

  1. Clinical Pregnancy Rate

    Time frame: 20 days after embryo transfer

    Defined as the proportion of patients with a gestational sac seen 20 days after embryo transfer

Secondary outcomes

  1. Biochemical Pregnancy Rate

    Time frame: 9 days after embryo transfer

    Defined as the proportion of patients with ≥25 mIU/L of serum βhCG 9 days after embryo transfer

  2. Early Pregnancy Loss Rate

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fundacion Dexeus

Other

Registry information

Official study title

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

Acronym: MUCRET

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 26, 2017
Registry last updated
May 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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