Unexplained InfertilityNCT02539290
Preovulatory Uterine Flushing With Saline as a Treatment for Unexplained Infertility
A study testing Detection of ovulation, Uterine flushing and Vaginal flushing in people with Unexplained Infertility and Infertility, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether preovulatory uterine flushing with physiological saline is effective in the treatment of unexplained infertility. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- Unexplained Infertility, Infertility
- What is being tested?
- Detection of ovulation, Uterine flushing and Vaginal flushing
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteCanada
- Study dates
- 30 Dec 2015to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Primary or secondary infertility ≥12 months.
- Diagnosis of unexplained infertility ≤24 months:
- Anti-Mullerian hormone ≥0.4 ng/mL and/or follicle-stimulating hormone ≤13 IU/L in early follicular phase;
- regular cycle of 21-35 days,
- positive ovulation tests, and/or
- luteal phase serum progesterone ≥25mmol/L in a natural cycle;
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- semen analysis with total motile sperm count ≥ 5 million;
- normal uterine cavity;
- patent tubes.
- Negative genitourinary test for gonorrhoea and chlamydia ≤12 months.
Who cannot join
- Body mass index ≥35 kg/m2.
- Ongoing pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preovulatory Uterine Flushing With Saline as a Treatment for Unexplained Infertility: A Randomised Controlled Trial Protocol
The purpose of this study is to determine whether preovulatory uterine flushing with physiological saline is effective in the treatment of unexplained infertility.
Read the detailed description
In vitro fertilisation is the only current reasonable treatment for unexplained infertility. Uterine flushing, associated with a five-fold increase in pregnancy when performed preovulatory, has been proposed as a new alternative. This treatment could flush out debris or alter inflammatory factors preventing fertilisation and implantation. The objective of this study is to assess the efficacy of pre-ovulatory uterine flushing with physiological saline for the treatment of unexplained infertility. This study is a randomised controlled trial based on consecutive women aged between 18 and 37 years consulting for unexplained infertility for at least one year. The day of their luteinizing hormone surge, 192 participants will be randomised in two equal groups to either receive 20 millilitres of physiological saline by an intra-uterine catheter or 10 millilitres of saline intravaginally. Investigators will assess relative risk of live birth (primary outcome), as well as pregnancy over one cycle of treatment. Side effects, complications, and acceptability of the intervention will be reported.
- Conditions
- Unexplained Infertility, Infertility
- Being tested
- Detection of ovulation, Uterine flushing, Vaginal flushing, Sexual intercourse
- Keywords
- Unexplained infertility, Infertility, Tubal flushing, Uterine flushing, Live birth, Pregnancy, Randomized controlled trial, Saline, Physiological saline
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of ovulationBehavioural
Detecting the luteinizing hormone surge using test sticks in a urine sample
Uterine flushingProcedure or surgery
Also called Tubal flushing
Injection of 20 millilitres of physiological saline by an intra-uterine catheter the day of the luteinizing hormone surge
Vaginal flushingProcedure or surgery
Injection of 10 millilitres of physiological saline intravaginally the day of the luteinizing hormone surge
Sexual intercourseBehavioural
Sexual intercourse on the day of the intervention and the following day
| Study group | Role | What they receive |
|---|---|---|
| Uterine flushing | Experimental | Detection of ovulation, injection of 20 millilitres of physiological saline by an intra-uterine catheter the day of the luteinizing hormone surge, and sexual intercourse within 12 hours after intervention Receives: Behavioral: Detection of ovulation; Procedure: Uterine flushing; Behavioral: Sexual intercourse |
| Vaginal flushing | Sham comparator | Detection of ovulation, injection of 10 millilitres of physiological saline intravaginally the day of the luteinizing hormone surge, and sexual intercourse within 12 hours after intervention Receives: Behavioral: Detection of ovulation; Procedure: Vaginal flushing; Behavioral: Sexual intercourse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with a live birth resulting from one cycle of treatment
Proportion of participants with a live birth resulting from one cycle of treatment based on questionnaire and medical data.
Measured: 10 months after randomisation
Secondary outcomes (3)
Proportion of participants with a pregnancy resulting from one cycle of treatment
Proportion of participants with a positive urinary or serum pregnancy test, gestational sac on ultrasound or histological evidence of trophoblastic tissue resulting from one cycle of treatment based on questionnaire and medical data.
Measured: One month after randomisation
Adverse effects
Number of participants with treatment-related pain, vagal symptoms, nausea, vomiting, temperature, pelvic infection
Measured: One month after randomisation
Proportion of participants who find the intervention acceptable
Proportion of participants that would be willing to receive the intervention for a second time and find the intervention acceptable.
Measured: One month after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study start30 Dec 2015
- Primary completion30 Sep 2024
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unexplained 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvie Dodin, MD-MSc, Study director, Centre Hospitalier Universitaire de Quebec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539290
- Sponsor's protocol ID
- 2015-1146
- Status last verified
- Jan 2025
- First submitted
- 26 Aug 2015
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Maheux-Lacroix S, Dodin S, Moore L, Bujold E, Lefebvre J, Bergeron ME. Preovulatory uterine flushing with saline as a treatment for unexplained infertility: a randomised controlled trial protocol. BMJ Open. 2016 Jan 6;6(1):e009897. doi: 10.1136/bmjopen-2015-009897.
PubMed 26739737
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preovulatory Uterine Flushing With Saline as a Treatment for Unexplained Infertility: A Randomised Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT02539290
- Acronym / sponsor ID
- 2015-1146
- Conditions
- Unexplained Infertility, Infertility
- Keywords
- Unexplained infertility, Infertility, Tubal flushing, Uterine flushing, Live birth, Pregnancy, Randomized controlled trial, Saline
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Study start
- 30 Dec 2015 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 3 Sep 2015 (estimated)
- 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.
The purpose of this study is to determine whether preovulatory uterine flushing with physiological saline is effective in the treatment of unexplained infertility.
Detailed description
In vitro fertilisation is the only current reasonable treatment for unexplained infertility. Uterine flushing, associated with a five-fold increase in pregnancy when performed preovulatory, has been proposed as a new alternative. This treatment could flush out debris or alter inflammatory factors preventing fertilisation and implantation. The objective of this study is to assess the efficacy of pre-ovulatory uterine flushing with physiological saline for the treatment of unexplained infertility. This study is a randomised controlled trial based on consecutive women aged between 18 and 37 years consulting for unexplained infertility for at least one year. The day of their luteinizing hormone surge, 192 participants will be randomised in two equal groups to either receive 20 millilitres of physiological saline by an intra-uterine catheter or 10 millilitres of saline intravaginally. Investigators will assess relative risk of live birth (primary outcome), as well as pregnancy over one cycle of treatment. Side effects, complications, and acceptability of the intervention will be reported.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uterine flushing | Experimental | Behavioral: Detection of ovulation, Procedure: Uterine flushing, Behavioral: Sexual intercourseDetection of ovulation, injection of 20 millilitres of physiological saline by an intra-uterine catheter the day of the luteinizing hormone surge, and sexual intercourse within 12 hours after intervention |
| Vaginal flushing | Sham comparator | Behavioral: Detection of ovulation, Procedure: Vaginal flushing, Behavioral: Sexual intercourseDetection of ovulation, injection of 10 millilitres of physiological saline intravaginally the day of the luteinizing hormone surge, and sexual intercourse within 12 hours after intervention |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Primary or secondary infertility ≥12 months.
- Diagnosis of unexplained infertility ≤24 months:
- Negative genitourinary test for gonorrhoea and chlamydia ≤12 months.
Key exclusion criteria (2 listed)
- Body mass index ≥35 kg/m2.
- Ongoing pregnancy.
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 |
|---|---|---|
| Detection of ovulationDetecting the luteinizing hormone surge using test sticks in a urine sample | Behavioural | Uterine flushing, Vaginal flushing |
| Uterine flushingAlso: Tubal flushingInjection of 20 millilitres of physiological saline by an intra-uterine catheter the day of the luteinizing hormone surge | Procedure or surgery | Uterine flushing |
| Vaginal flushingInjection of 10 millilitres of physiological saline intravaginally the day of the luteinizing hormone surge | Procedure or surgery | Vaginal flushing |
| Sexual intercourseSexual intercourse on the day of the intervention and the following day | Behavioural | Uterine flushing, Vaginal flushing |
Primary outcome
Proportion of participants with a live birth resulting from one cycle of treatment
Time frame: 10 months after randomisation
Proportion of participants with a live birth resulting from one cycle of treatment based on questionnaire and medical data.
3 secondary outcomes
Proportion of participants with a pregnancy resulting from one cycle of treatment
Time frame: One month after randomisation
Adverse effects
Time frame: One month after randomisation
Proportion of participants who find the intervention acceptable
Time frame: One month after randomisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Derived from this study: PubMed 26739737Maheux-Lacroix S, Dodin S, Moore L, Bujold E, Lefebvre J, Bergeron ME. Preovulatory uterine flushing with saline as a treatment for unexplained infertility: a randomised controlled trial protocol. BMJ Open. 2016 Jan 6;6(1):e009897. doi: 10.1136/bmjopen-2015-009897.
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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.
Sylvie Dodin, MD-MSc study director
Centre Hospitalier Universitaire de Quebec
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Detection of ovulation, Uterine flushing and Vaginal flushing in people with Unexplained Infertility and Infertility, run by CHU de Quebec-Universite Laval at 1 site in Canada.
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 10 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2025. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of participants with a live birth resulting from one cycle of treatment (time frame: 10 months after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02539290, which also lists 1 linked publication.
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 13 Jan 2025.