Clinical trial NCT03292770: Mucus Removal Before Embryo Transfer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Embryo Transfer
Keywords: Embryo Transfer
Flushing catheter
Pregnancy rate
Frozen Embryo Tranfer
Lead sponsor: Fundacion Dexeus
Sponsor class: OTHER
First posted: 2017-09-26
Enrollment: 1118
Sex: FEMALE
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Pregnancy Rate
timeFrame: 20 days after embryo transfer
Secondary outcomes:
measure: Biochemical Pregnancy Rate
timeFrame: 9 days after embryo transfer
measure: Early Pregnancy Loss Rate
timeFrame: 20 days after embryo transfer
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitario Dexeus
Study officials:
affiliation: Hospital Universitario Dexeus
name: Jorge Rodriguez-Purata, MD
role: PRINCIPAL_INVESTIGATOR
References: