NCT03519763

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 9, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

June 13, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2020

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

1.5 years

First QC Date

April 25, 2018

Last Update Submit

February 24, 2020

Conditions

Endometrial Diseases

Outcome Measures

Primary Outcomes (1)

  • 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

    1year

Study Arms (3)

Control group

Fifteen patients without isthmocele

Diagnostic Test: ultrasound

Study subgroup1

15 patients with 1 previous C-Section

Study subgroup2

15 patients with 2 or more previous C-Section.

Diagnostic Test: ultrasound

Interventions

ultrasoundDIAGNOSTIC_TEST

All the patients will have a transvaginal ultrasound evaluation during the first visit to the clinic to evaluate the presence or not of isthmocele.

Also known as: transvaginal scan, ultrasound
Control groupStudy subgroup2

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Female patients undergoing IVF treatment.

You may qualify if:

  • 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).
  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVI Middle East Fertilty Clinic

Abu Dhabi, United Arab Emirates

Location

Related Publications (8)

  • 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.

    PMID: 24390919BACKGROUND

  • Ravel 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.

    PMID: 20534435BACKGROUND

  • Romero 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.

    PMID: 24987521BACKGROUND

  • Moreno 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.

    PMID: 27717732BACKGROUND

  • Tower 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.

    PMID: 23680518BACKGROUND

  • Vikhareva 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.

    PMID: 20604776BACKGROUND

  • Sim 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.

    PMID: 22470420BACKGROUND

  • Caporaso 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.

    PMID: 20383131BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

samples for Endometrial fluid (EF) and isthmocele fluid (IF) will be collected the day of the oocyte pick up after IVF stimulation for freeze-all oocytes or embryos.

MeSH Terms

Conditions

Uterine Diseases

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Human Fatemi, MD

    Medical Director

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 25, 2018

First Posted

May 9, 2018

Study Start

June 13, 2018

Primary Completion

November 30, 2019

Study Completion

February 24, 2020

Last Updated

February 25, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

AE(1)