Infertility, Female
Conditions
Brief summary
The purpose of this study is to comprehensively evaluate the transcriptomic signal of the endometrium before, during, and after the window of receptivity.
Detailed description
Phase 1 will aim to define a normal endometrial transcriptomic signature in healthy controls without infertility. Phase 2 will elucidate endometrial transcriptomic expression in patients with diagnoses of infertility unrelated to endometrial factor. Findings from this phase will be compared to the results of phase 1.
Interventions
OTHEREndometrial biopsy
All groups will undergo a mock frozen embryo transfer cycle with an endometrial biopsy being performed as opposed to an embryo transfer
Sponsors
Reproductive Medicine Associates of New Jersey
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Phase 1: Major Inclusion: The following are major inclusion criteria: 1. Regular menstrual cycles 2. Age 18-50 3. Normal baseline ultrasound 4. No intrauterine procedures in prior 90 days Exclusions: The following are
Exclusion criteria
1. Any contraindications to undergoing estrogen stimulation of the endometrium 1. Current smoking status 2. Multiple risk factors for arterial cardiovascular disease (smoking, diabetes, and hypertension) 3. Hypertension (systolic ≥140 mmHg or diastolic ≥90 mmHg) 4. Venous thromboembolism (current or history of) 5. Known thrombogenic mutations 6. Known ischemic heart disease 7. History of stroke 8. Complicated valvular heart disease (pulmonary hypertension, risk for atrial fibrillation, history of subacute bacterial endocarditis) 9. Systemic lupus erythematosus (positive or unknown antiphospholipid antibodies) 10. Migraine with aura at any age 11. Breast cancer 12. Cirrhosis 13. Hepatocellular adenoma or malignant hepatoma 2. History of infertility diagnosis 3. History of undiagnosed abnormal uterine bleeding. 4. Allergic reaction to any medication used for the preparatory cycle 5. Known pregnancy or delivery within the past 6 months 6. Breastfeeding 7. Obesity \>35 kg/m2 Phase 2 Major Inclusion: The following are major inclusion criteria: 1. Age 18-50 2. Diagnosis of infertility with low endometrial risk 3. No intrauterine procedures in prior 90 days Exclusions: In addition to the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| transcriptomic evaluation | 90 days | evaluation to characterize genes expressed during the window of implantation |
Countries
United States
Outcome results
None listed