Endometrial Diseases Clinical Trial
Official title:
Endometrial and Isthmic Microbiota During IVF Stimulation in Patients Affected With Isthmocele and Intrauterine Mucus Secretion After C-section.
Verified date | February 2020 |
Source | IVI Middle East Fertility Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 3 |
Est. completion date | February 24, 2020 |
Est. primary completion date | November 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: 1. 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). 2. 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). Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United Arab Emirates | IVI Middle East Fertilty Clinic | Abu Dhabi |
Lead Sponsor | Collaborator |
---|---|
IVI Middle East Fertility Clinic |
United Arab Emirates,
Caporaso JG, Kuczynski J, Stombaugh J, Bittinger K, Bushman FD, Costello EK, Fierer N, Peña 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. — View Citation
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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. — View Citation
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. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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