Mucus Removal Before Embryo Transfer

NCT03292770 | Completed

• 1 other identifier: SMD-CAT-2017-01
• Study Type: interventional
• Target: 1,118
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; Embryo Transfer

Keywords

Embryo Transfer; Flushing catheter; Pregnancy rate; Frozen Embryo Tranfer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Biochemical Pregnancy Rate

  9 days after embryo transfer

• Early Pregnancy Loss Rate

  20 days after embryo transfer

Study Arms (2)

Control Group

NO INTERVENTION

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.

Flushing Group

EXPERIMENTAL

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

Interventions

Flushing Catheter DEVICE

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

Flushing Group

Eligibility Criteria

• Age: Up to 40 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Preimplantation genetic diagnosis and/or screening

Sponsors & Collaborators

• Fundacion Dexeus: lead

Study Sites (1)

Hospital Universitario Dexeus

Barcelona, 08022, Spain

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Jorge Rodriguez-Purata, MD

  Hospital Universitario Dexeus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All included patients will be blinded of the procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Jorge Rodriguez-Purata

Model Details: 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.

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: September 26, 2017
• Study Start: October 20, 2017
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: May 31, 2018

Record last verified: 2018-05

Locations

ES (1)