Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04103242
Other study ID # 2017-01064 endoMB
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date December 31, 2022

Study information

Verified date June 2020
Source University Hospital, Basel, Switzerland
Contact Rebecca Moffat, MD
Phone +41 67 328 79 80
Email rebecca.moffat@usb.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Infertile women undergoing hysteroscopy for diagnostic or therapeutic indication are asked to donate a sample of endometrium.

Endometrial samples of study participants are examined for signs of chronic endometritis by immunohistochemical analysis.

High-throughput sequencing of the microbial 16s ribosomal ribonucleic acid (rRNA) subunit is performed to identify and quantify the microbes present in the sample.

Obstetric and reproductive outcome is recorded 12 months after hysteroscopy (telephone interview).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date December 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Infertile (= 12 months of unprotected regular intercourse) premenopausal women or women with = 2 consecutive miscarriages undergoing hysteroscopy. - Infertile women undergoing office hysteroscopy for other reasons, such as suspected intrauterine adhesions after curettage, irregular endometrium, uterine polyps, repeated implantation failure in assisted reproduction, etc.

- Signed informed consent

- BMI = 18 kg/m2 and = 40 kg/m2

- Age: = 18 years and = 45 years

- follicle stimulating hormone (FSH) = 20 (day 2-5 and estradiol = 300 pmol/l)

Exclusion Criteria:

- Treatment with antibiotics in the past 3 months

- Treatment with immune-suppressing or immune-modulating drugs in the past 3 months

- Treatment with estrogens, progestins, contraceptives and/or antiestrogenic drugs in the cycle during which hysteroscopy is performed

- Current infection of the cervix with Chlamydia trachomatis and/or gonorrhea

- Pelvic surgery in the past 3 months

- Suspicion of malignancy

- Pregnancy

- Breast feeding

- Perimenopause (irregular menses and FSH = 20 U/l on day 3-5 of the cycle)

- Outdated endometrial sample from the luteal phase (this criterion will be evaluated during visit 4 post surgery)

- Elevated progesterone concentration = 20 nmol/l measured in the blood sample taken at the time of HSC.

- Insufficient amount of tissue for immunohistochemical analysis and/or microbial 16s rRNA gene sequencing

Study Design


Related Conditions & MeSH terms


Intervention

Other:
16s rRNA gene sequencing
High-throughput sequencing of the microbial 16s rRNA subunit to define the abundance of microbial phyla and genera

Locations

Country Name City State
Switzerland University Hospital Basel Basel

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quantity of Lactobacillus Quantity of Lactobacillus determined by 16S ribosomal RNA gene sequencing 1 year
Primary alpha diversity of microbes Quantification of microbes and their diversity within the individual endometrium sample 1 year
Primary Shannon index (Beta diversity) Comparison of microbial diversity among the subjects 1 Year
Secondary Pregnancy Rate Number of pregnancies within 12 months after hysteroscopy 2 years
Secondary Live Birth Rate Number of pregnancies within 12 months after hysteroscopy 3 years
See also
  Status Clinical Trial Phase
Recruiting NCT05969574 - Is Decreased Ovarian Reserve Related to an Increased Number of Previous Early Miscarriages?
Recruiting NCT05358483 - PROspective Study of Mothers' and Infants' Social and Epidemiologic Determinants of Health
Recruiting NCT05969795 - Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support Phase 1
Recruiting NCT06051201 - Innovation for Small-scale Experiments: ReceptIVFity Test N/A
Completed NCT03177538 - Corifollitropin Alfa Combined With Menotropin Versus Follitropin and Lutropin Alfa in Expected Suboptimal Responders Phase 4
Completed NCT03638856 - Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Hysteroscopy N/A
Completed NCT04052464 - The Study of the Implantation Window From Endometrial Biopsy With Gene Expression Methods
Withdrawn NCT04753736 - Immunophenotypage of RIF and RM Patients and Intrauterine Administration of PBMC N/A
Completed NCT03349905 - Deferred Versus Fresh Embryo Transfers N/A
Completed NCT05076981 - Progesterone Levels During Ovulation and Luteal Phase
Completed NCT04096027 - Cabergoline Before or After Oocyte Collection for Follicular Resolution Phase 4
Recruiting NCT05980091 - Optimal Timing of Euploid Day 6 Blastocyst Transfer in Frozen HRT Cycles, Day 6 or Day 7 of Progesterone Administration. Phase 1
Terminated NCT01933633 - Improved Fertility After Exercise in Overweight/Obese Women N/A
Terminated NCT01202643 - Effect of Colony Stimulating Factor on Poor Endometrial Development During IVF Phase 1/Phase 2
Completed NCT01202656 - Effect of Colony Stimulating Factor on Implantation and Pregnancy Rates Following IVF (in Vitro Fertilization) Phase 1/Phase 2
Completed NCT01408615 - A Post Marketing Observational Study of the Safety and Efficacy of Elonva (Corifollitropin Alfa) in General Practice (P08165)
Enrolling by invitation NCT05698550 - The Role of Erzhi Tiangui Formula in Expected POR Women Undergoing IVF-ET Phase 3
Not yet recruiting NCT03910582 - Personalized FET in RIF Patients With Displaced Dating N/A
Completed NCT05440019 - Evaluation of the Safety and Usability of the M3T Fertigo System and Its Calibration
Completed NCT05130125 - Retrospective Cohort Observational Study to Evaluate the Effectiveness and Safety of Fresh or Frozen Embryo Transfer