Mucus Removal Before Embryo Transfer

Infertility Clinical Trial

— MUCRET  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03292770
• Other study ID #: SMD-CAT-2017-01
• Status: Completed
• Phase: N/A
• Start date: October 20, 2017
• Est. completion date: May 30, 2018

Study information

• Verified date: May 2018
• Source: Institut Universitari Dexeus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1118
• Est. completion date: May 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Embryo Transfer
• Infertility

Intervention

Device:
• Flushing Catheter
A catheter will be used to performed a flushing of the cervical canal with culture media.

Locations

Country	Name	City	State
Spain	Hospital Universitario Dexeus	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Institut Universitari Dexeus

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Biochemical Pregnancy Rate	Defined as the proportion of patients with =25 mIU/L of serum ßhCG 9 days after embryo transfer	9 days after embryo transfer
Secondary	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