Endometrial DiseasesNCT03519763
Intrauterine Microbiota During IVF in Patients Affected With Isthmocele.
An observational study of Endometrial Diseases, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.
Trial summary
To evaluate the endometrial and isthmic microbiota in patients with isthmocele after C-Section, and if this microbiota is similar or not with better reproductive outcomes. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Diseases
- What is being tested?
- ultrasound
- How many people
- 3 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 13 Jun 2018to 24 Feb 2020
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Female patients undergoing IVF treatment.
Who may be able to join
- Patients with isthmocele:
- Patients performing IVF treatment with a planned cycle segmentation and consecutive frozen embryo transfer on a hormone replacement therapy (HRT) cycle or natural cycle.
- Age between 18 - 45 years all (both inclusive).
- One or multiple C-sections.
- Isthmocele present during TV scan.
- BMI: 18,5 - 35 kg / m2 (both inclusive).
Show all 10Show fewer
- Patients without isthmocele:
- Patients performing IVF treatment with planned cycle segmentation and who would have embryo transfer with frozen embryos under hormone replacement therapy.
- NO Isthmocele present during transvaginal ultrasound.
- BMI: 18,5 - 30 kg / m2 (both inclusive).
Who cannot join
- Age < 18 and > 45 years old.
- Previous or active endometritis.
- Patients who are IUD carriers for the last 3 months.
- Patients who have taken prescribed antibiotics in the last 3 months previous to sample collection.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
IVI Middle East Fertilty Clinic
Abu Dhabi
About this study
Official title: Endometrial and Isthmic Microbiota During IVF Stimulation in Patients Affected With Isthmocele and Intrauterine Mucus Secretion After C-section.
To evaluate the endometrial and isthmic microbiota in patients with isthmocele after C-Section, and if this microbiota is similar or not with better reproductive outcomes.
Read the detailed description
A total of 45 subjects undergoing in vitro fertilization treatment. Fifteen patients without isthmocele will be included in the control group and 30 patients affected with isthmocele in the other group, divided in 2 subgroups: 15 with 1 previous C-Section, and 15 with 2 or more previous C-Section. Paired samples of endometrial fluid (EF) and isthmic fluid (IF) will be obtained simultaneously the day of egg retrieval. Patients will follow a protocol for all-freezing embryos or oocytes.
- Conditions
- Endometrial Diseases
- Being tested
- ultrasound
- Medical subject headings
- Uterine Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDiagnostic test
Also called transvaginal scan, ultrasound
All the patients will have a transvaginal ultrasound evaluation during the first visit to the clinic to evaluate the presence or not of isthmocele.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Fifteen patients without isthmocele Receives: Diagnostic Test: ultrasound | |
| Study subgroup1 | 15 patients with 1 previous C-Section | |
| Study subgroup2 | 15 patients with 2 or more previous C-Section. Receives: Diagnostic Test: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
If the intrauterine microbiota profile in patients affected with isthmocele differs from the one found in patients without isthmocele.
patients undergoing in vitro fertilization treatment
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start13 Jun 2018
- Primary completion30 Nov 2019
- Study completion24 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Endometrial DiseasesStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- ART Fertility Clinics LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Dr. Human Fatemi, ART Fertility Clinics LLC
- Investigators
- Human Fatemi, MD, Principal investigator, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519763
- Sponsor's protocol ID
- 1707-ABU-065-HF
- Status last verified
- Feb 2020
- First submitted
- 25 Apr 2018
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sirota I, Zarek SM, Segars JH. Potential influence of the microbiome on infertility and assisted reproductive technology. Semin Reprod Med. 2014 Jan;32(1):35-42. doi: 10.1055/s-0033-1361821. Epub 2014 Jan 3.
PubMed 24390919Ravel J, Gajer P, Abdo Z, Schneider GM, Koenig SS, McCulle SL, Karlebach S, Gorle R, Russell J, Tacket CO, Brotman RM, Davis CC, Ault K, Peralta L, Forney LJ. Vaginal microbiome of reproductive-age women. Proc Natl Acad Sci U S A. 2011 Mar 15;108 Suppl 1(Suppl 1):4680-7. doi: 10.1073/pnas.1002611107. Epub 2010 Jun 3.
PubMed 20534435Romero R, Hassan SS, Gajer P, Tarca AL, Fadrosh DW, Bieda J, Chaemsaithong P, Miranda J, Chaiworapongsa T, Ravel J. The vaginal microbiota of pregnant women who subsequently have spontaneous preterm labor and delivery and those with a normal delivery at term. Microbiome. 2014 May 27;2:18. doi: 10.1186/2049-2618-2-18. eCollection 2014.
PubMed 24987521Moreno I, Codoner FM, Vilella F, Valbuena D, Martinez-Blanch JF, Jimenez-Almazan J, Alonso R, Alama P, Remohi J, Pellicer A, Ramon D, Simon C. Evidence that the endometrial microbiota has an effect on implantation success or failure. Am J Obstet Gynecol. 2016 Dec;215(6):684-703. doi: 10.1016/j.ajog.2016.09.075. Epub 2016 Oct 4.
PubMed 27717732Tower AM, Frishman GN. Cesarean scar defects: an underrecognized cause of abnormal uterine bleeding and other gynecologic complications. J Minim Invasive Gynecol. 2013 Sep-Oct;20(5):562-72. doi: 10.1016/j.jmig.2013.03.008. Epub 2013 May 14.
PubMed 23680518Vikhareva Osser O, Valentin L. Risk factors for incomplete healing of the uterine incision after caesarean section. BJOG. 2010 Aug;117(9):1119-26. doi: 10.1111/j.1471-0528.2010.02631.x.
PubMed 20604776Sim K, Cox MJ, Wopereis H, Martin R, Knol J, Li MS, Cookson WO, Moffatt MF, Kroll JS. Improved detection of bifidobacteria with optimised 16S rRNA-gene based pyrosequencing. PLoS One. 2012;7(3):e32543. doi: 10.1371/journal.pone.0032543. Epub 2012 Mar 28.
PubMed 22470420Caporaso JG, Kuczynski J, Stombaugh J, Bittinger K, Bushman FD, Costello EK, Fierer N, Pena AG, Goodrich JK, Gordon JI, Huttley GA, Kelley ST, Knights D, Koenig JE, Ley RE, Lozupone CA, McDonald D, Muegge BD, Pirrung M, Reeder J, Sevinsky JR, Turnbaugh PJ, Walters WA, Widmann J, Yatsunenko T, Zaneveld J, Knight R. QIIME allows analysis of high-throughput community sequencing data. Nat Methods. 2010 May;7(5):335-6. doi: 10.1038/nmeth.f.303. Epub 2010 Apr 11. No abstract available.
PubMed 20383131
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial and Isthmic Microbiota During IVF Stimulation in Patients Affected With Isthmocele and Intrauterine Mucus Secretion After C-section.
- ClinicalTrials.gov ID
- NCT03519763
- Acronym / sponsor ID
- 1707-ABU-065-HF
- Conditions
- Endometrial Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- ART Fertility Clinics LLCUniversity, hospital or other
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 24 Feb 2020 (actual)
- First posted
- 9 May 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.
To evaluate the endometrial and isthmic microbiota in patients with isthmocele after C-Section, and if this microbiota is similar or not with better reproductive outcomes.
Detailed description
A total of 45 subjects undergoing in vitro fertilization treatment. Fifteen patients without isthmocele will be included in the control group and 30 patients affected with isthmocele in the other group, divided in 2 subgroups: 15 with 1 previous C-Section, and 15 with 2 or more previous C-Section. Paired samples of endometrial fluid (EF) and isthmic fluid (IF) will be obtained simultaneously the day of egg retrieval. Patients will follow a protocol for all-freezing embryos or oocytes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Diagnostic Test: ultrasoundFifteen patients without isthmocele |
| Study subgroup1 | – | –15 patients with 1 previous C-Section |
| Study subgroup2 | – | Diagnostic Test: ultrasound15 patients with 2 or more previous C-Section. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Female patients undergoing IVF treatment.
Key inclusion criteria (10 listed)
- Patients with isthmocele:
- Patients without isthmocele:
Key exclusion criteria (4 listed)
- Age < 18 and > 45 years old.
- Previous or active endometritis.
- Patients who are IUD carriers for the last 3 months.
- Patients who have taken prescribed antibiotics in the last 3 months previous to sample collection.
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 |
|---|---|---|
| ultrasoundAlso: transvaginal scan, ultrasoundAll the patients will have a transvaginal ultrasound evaluation during the first visit to the clinic to evaluate the presence or not of isthmocele. | Diagnostic test | Control group, Study subgroup2 |
Primary outcome
If the intrauterine microbiota profile in patients affected with isthmocele differs from the one found in patients without isthmocele.
Time frame: 1year
patients undergoing in vitro fertilization treatment
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 25 Feb 2020.
- Background: PubMed 24390919Sirota I, Zarek SM, Segars JH. Potential influence of the microbiome on infertility and assisted reproductive technology. Semin Reprod Med. 2014 Jan;32(1):35-42. doi: 10.1055/s-0033-1361821. Epub 2014 Jan 3.
- Background: PubMed 20534435Ravel J, Gajer P, Abdo Z, Schneider GM, Koenig SS, McCulle SL, Karlebach S, Gorle R, Russell J, Tacket CO, Brotman RM, Davis CC, Ault K, Peralta L, Forney LJ. Vaginal microbiome of reproductive-age women. Proc Natl Acad Sci U S A. 2011 Mar 15;108 Suppl 1(Suppl 1):4680-7. doi: 10.1073/pnas.1002611107. Epub 2010 Jun 3.
- Background: PubMed 24987521Romero R, Hassan SS, Gajer P, Tarca AL, Fadrosh DW, Bieda J, Chaemsaithong P, Miranda J, Chaiworapongsa T, Ravel J. The vaginal microbiota of pregnant women who subsequently have spontaneous preterm labor and delivery and those with a normal delivery at term. Microbiome. 2014 May 27;2:18. doi: 10.1186/2049-2618-2-18. eCollection 2014.
- Background: PubMed 27717732Moreno I, Codoner FM, Vilella F, Valbuena D, Martinez-Blanch JF, Jimenez-Almazan J, Alonso R, Alama P, Remohi J, Pellicer A, Ramon D, Simon C. Evidence that the endometrial microbiota has an effect on implantation success or failure. Am J Obstet Gynecol. 2016 Dec;215(6):684-703. doi: 10.1016/j.ajog.2016.09.075. Epub 2016 Oct 4.
- Background: PubMed 23680518Tower AM, Frishman GN. Cesarean scar defects: an underrecognized cause of abnormal uterine bleeding and other gynecologic complications. J Minim Invasive Gynecol. 2013 Sep-Oct;20(5):562-72. doi: 10.1016/j.jmig.2013.03.008. Epub 2013 May 14.
- Background: PubMed 20604776Vikhareva Osser O, Valentin L. Risk factors for incomplete healing of the uterine incision after caesarean section. BJOG. 2010 Aug;117(9):1119-26. doi: 10.1111/j.1471-0528.2010.02631.x.
- Background: PubMed 22470420Sim K, Cox MJ, Wopereis H, Martin R, Knol J, Li MS, Cookson WO, Moffatt MF, Kroll JS. Improved detection of bifidobacteria with optimised 16S rRNA-gene based pyrosequencing. PLoS One. 2012;7(3):e32543. doi: 10.1371/journal.pone.0032543. Epub 2012 Mar 28.
- Background: PubMed 20383131Caporaso JG, Kuczynski J, Stombaugh J, Bittinger K, Bushman FD, Costello EK, Fierer N, Pena AG, Goodrich JK, Gordon JI, Huttley GA, Kelley ST, Knights D, Koenig JE, Ley RE, Lozupone CA, McDonald D, Muegge BD, Pirrung M, Reeder J, Sevinsky JR, Turnbaugh PJ, Walters WA, Widmann J, Yatsunenko T, Zaneveld J, Knight R. QIIME allows analysis of high-throughput community sequencing data. Nat Methods. 2010 May;7(5):335-6. doi: 10.1038/nmeth.f.303. Epub 2010 Apr 11. No abstract available.
- Individual participant dataSharing planned: No
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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.
Human Fatemi, MD principal investigator
Medical Director
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 Endometrial Diseases, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.
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 4 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 25 Feb 2020. 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 United Arab Emirates. 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?
If the intrauterine microbiota profile in patients affected with isthmocele differs from the one found in patients without isthmocele. (time frame: 1year). 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 NCT03519763, which also lists 8 linked publications.
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 25 Feb 2020.