InfertilityMUCRETNCT03292770
Mucus Removal Before Embryo Transfer
A study testing Flushing Catheter in people with Infertility and Embryo Transfer, run by Fundacion Dexeus at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages Up to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Embryo Transfer
- What is being tested?
- Flushing Catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,118 participants
- Where
- 1 siteSpain
- Study dates
- 20 Oct 2017to 30 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Preimplantation genetic diagnosis and/or screening
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Infertility, Embryo Transfer
- Being tested
- Flushing Catheter
- Keywords
- Embryo Transfer, Flushing catheter, Pregnancy rate, Frozen Embryo Tranfer
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flushing CatheterDevice
A catheter will be used to performed a flushing of the cervical canal with culture media.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Flushing Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy Rate
Defined as the proportion of patients with a gestational sac seen 20 days after embryo transfer
Measured: 20 days after embryo transfer
Secondary outcomes (2)
Biochemical Pregnancy Rate
Defined as the proportion of patients with ≥25 mIU/L of serum βhCG 9 days after embryo transfer
Measured: 9 days after embryo transfer
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
Measured: 20 days after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start20 Oct 2017
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Dexeus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Rodriguez-Purata, Fundacion Dexeus
- Investigators
- Jorge Rodriguez-Purata, MD, Principal investigator, Hospital Universitario Dexeus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292770
- Sponsor's protocol ID
- SMD-CAT-2017-01
- Acronym
- MUCRET
- Status last verified
- May 2018
- First submitted
- 21 Sep 2017
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03292770
- Acronym / sponsor ID
- MUCRET / SMD-CAT-2017-01
- Conditions
- Infertility, Embryo Transfer
- Keywords
- Embryo Transfer, Flushing catheter, Pregnancy rate, Frozen Embryo Tranfer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,118 participants (actual)
- Lead sponsor
- Fundacion DexeusUniversity, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 26 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Flushing CatheterA 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). |
Who may qualify
- Ages
- Up to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Preimplantation genetic diagnosis and/or screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flushing CatheterA catheter will be used to performed a flushing of the cervical canal with culture media. | Device | Flushing Group |
Primary outcome
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
2 secondary outcomes
Biochemical Pregnancy Rate
Time frame: 9 days after embryo transfer
Early Pregnancy Loss Rate
Time frame: 20 days after embryo transfer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Rodriguez-Purata, MD principal investigator
Hospital Universitario Dexeus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flushing Catheter in people with Infertility and Embryo Transfer, run by Fundacion Dexeus at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Pregnancy Rate (time frame: 20 days after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2018.