Abnormal Vaginal MicrobiotaNCT03420859
The Microbiome of Infertile Couples and Its Effect on Their Reproductive Outcomes
An observational study of Abnormal Vaginal Microbiota and Infertility, run by Peter Humaidan at 1 site in Denmark.
Trial summary
A prospective cohort study in IVF patients at 5 IVF centres in Denmark. The primary aim is to include patients positive for abnormal vaginal microbiota to an RCT (EUDRACT 2016-002385-31). Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Abnormal Vaginal Microbiota, Infertility
- What is being tested?
- qPCR for abnormal vaginal microbiota
- How many people
- 1,850 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Dec 2017to 1 Jan 2024
- Phase
- Observational
- 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 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Study population: Infertile women fulfilling the abovementioned criteria.
Who may be able to join
- First, second or third IVF stimulation cycle at the involved clinic.
- BMI<35.
- Written informed consent.
- 18-42 years old
Who cannot join
- HIV, Hepatitis B or C positivity.
- Intrauterine malformations (Vaginal ultrasound)
- Hysterosalpinx
- Known severe renal or hepatic impairment.
- HPV CIN 2 or higher.
- Patients treated with vitamin K antagonists (warfarin)
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- Known or suspected hypersensitivity to clindamycin or any other antibiotic.
- Myastenia Gravis
- Former or current inflammatory bowel disease, including Mb. Crohn and Colitis ulcerosa
- Any uncontrolled concomitant disease (e.g. uncontrolled diabetes, uncontrolled hypertension etc.)
Trial locations and contacts
1 site in 1 country.
About this study
A prospective cohort study in IVF patients at 5 IVF centres in Denmark. The primary aim is to include patients positive for abnormal vaginal microbiota to an RCT (EUDRACT 2016-002385-31). Secondary aims are the prevalence of abnormal vaginal microbiota in women undergoing IVF treatment, intimate hygiene and relations to the vaginal microbiota, basic fertility work up in relation to vaginal microbiota.
Read the detailed description
At the time of the interim stage of the RCT (EUDRACT 2016-002385-31), we plan to make a first cross-sectional investigation of the intimate hygiene questionnaire at baseline as compared to abnormal vaginal microbiota. We plan to make focused interview of N=30 patients to cover any additional female hygiene details not covered in the original questionnaire. After this investigation we may include new questions after the interim analysis - given that the study proceeds. In this case we plan to publish the first results of the intimate hygiene habits of the patients enrolled until interim stage.
- Conditions
- Abnormal Vaginal Microbiota, Infertility
- Being tested
- qPCR for abnormal vaginal microbiota
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
qPCR for abnormal vaginal microbiotaDiagnostic test
qPCR for A.vaginae and/or G.vaginalis as developed in the pilot study (Hum Reprod. 2016 Apr;31(4):795-803. doi: 10.1093/humrep/dew026. Epub 2016 Feb 23.)
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormal vaginal microbiota
qPCR positive diagnosis as described in intervention.
Measured: minimum 2-7 days from vaginal swab.
Secondary outcomes (5)
Intimate hygiene
questionnaire
Measured: 2-5 weeks from baseline to embryo transfer
Male/partner seminal microbiome
DNA sequencing of seminal samples
Measured: 2-4 weeks from baseline to oocyte pick-up
Number of participants with Clinical pregnancy as measured by heartbeat
Tested by ultrasound scanning in week 7-9.
Measured: 7-9 weeks after inclusion.
Number of participants achieving Live birth (defined as birth of a living child later than 23 weeks)
Tested by self-reported schemes mailed to the clinics.
Measured: 36-42 weeks after inclusion
Cumulative live birth rate
The number of live births originating from one controlled ovarian stimulation.
Measured: 9 months - 24 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start4 Dec 2017
- Primary completion8 Aug 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal Vaginal MicrobiotaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter Humaidan
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Statens Serum Institut, Stork Fertility Clinic, VivaNeo, Copenhagen, Hvidovre Fertility Clinic, Copenhagen, Køge Fertility Clinic, Denmark
- Responsible party
- Sponsor-investigator, Peter Humaidan, Regionshospitalet Viborg, Skive
- Investigators
- Peter Humaidan, Professor, Principal investigator, The Fertility Clinic Skive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420859
- Sponsor's protocol ID
- 1-16-02-404-16 (datatilsynet)
- Status last verified
- Apr 2023
- First submitted
- 1 Jan 2018
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: By Danish law, we cannot share individual data. But pseudomized data might be available from the National Danish archives. We aim to publish as fully as possible by Danish data protection law.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Microbiome of Infertile Couples and Its Effect on Their Reproductive Outcomes
- ClinicalTrials.gov ID
- NCT03420859
- Acronym / sponsor ID
- 1-16-02-404-16 (datatilsynet)
- Conditions
- Abnormal Vaginal Microbiota, Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,850 participants (estimated)
- Lead sponsor
- Peter HumaidanUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Statens Serum Institut, Stork Fertility Clinic, VivaNeo, Copenhagen, Hvidovre Fertility Clinic, Copenhagen, Køge Fertility Clinic, Denmark
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 8 Aug 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 5 Feb 2018 (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.
A prospective cohort study in IVF patients at 5 IVF centres in Denmark. The primary aim is to include patients positive for abnormal vaginal microbiota to an RCT (EUDRACT 2016-002385-31). Secondary aims are the prevalence of abnormal vaginal microbiota in women undergoing IVF treatment, intimate hygiene and relations to the vaginal microbiota, basic fertility work up in relation to vaginal microbiota.
Detailed description
At the time of the interim stage of the RCT (EUDRACT 2016-002385-31), we plan to make a first cross-sectional investigation of the intimate hygiene questionnaire at baseline as compared to abnormal vaginal microbiota. We plan to make focused interview of N=30 patients to cover any additional female hygiene details not covered in the original questionnaire. After this investigation we may include new questions after the interim analysis - given that the study proceeds. In this case we plan to publish the first results of the intimate hygiene habits of the patients enrolled until interim stage.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Infertile women fulfilling the abovementioned criteria.
Key inclusion criteria (4 listed)
- First, second or third IVF stimulation cycle at the involved clinic.
- BMI<35.
- Written informed consent.
- 18-42 years old
Key exclusion criteria (10 listed)
- HIV, Hepatitis B or C positivity.
- Intrauterine malformations (Vaginal ultrasound)
- Hysterosalpinx
- Known severe renal or hepatic impairment.
- HPV CIN 2 or higher.
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 |
|---|---|---|
| qPCR for abnormal vaginal microbiotaqPCR for A.vaginae and/or G.vaginalis as developed in the pilot study (Hum Reprod. 2016 Apr;31(4):795-803. doi: 10.1093/humrep/dew026. Epub 2016 Feb 23.) | Diagnostic test | – |
Primary outcome
Abnormal vaginal microbiota
Time frame: minimum 2-7 days from vaginal swab.
qPCR positive diagnosis as described in intervention.
5 secondary outcomes
Intimate hygiene
Time frame: 2-5 weeks from baseline to embryo transfer
Male/partner seminal microbiome
Time frame: 2-4 weeks from baseline to oocyte pick-up
Number of participants with Clinical pregnancy as measured by heartbeat
Time frame: 7-9 weeks after inclusion.
Number of participants achieving Live birth (defined as birth of a living child later than 23 weeks)
Time frame: 36-42 weeks after inclusion
Cumulative live birth rate
Time frame: 9 months - 24 months after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: Undecided. By Danish law, we cannot share individual data. But pseudomized data might be available from the National Danish archives. We aim to publish as fully as possible by Danish data protection law.
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.
Peter Humaidan, Professor principal investigator
The Fertility Clinic Skive
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abnormal Vaginal Microbiota and Infertility, run by Peter Humaidan at 1 site in Denmark.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 27 Apr 2023. 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 Denmark. 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?
Results are not available in the source record.
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?
Abnormal vaginal microbiota (time frame: minimum 2-7 days from vaginal swab.). 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 27 Apr 2023.