Transcriptomic Evaluation of Endometrial Receptivity

Study Overview
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Brief Summary
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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
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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.

Official Title
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Transcriptomic Evaluation of Endometrial Receptivity

Conditions
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Infertility, Female

Intervention / Treatment
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* Other: Endometrial biopsy


Participation Criteria
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Eligibility Criteria
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Phase 1: Major Inclusion: The following are major inclusion criteria: Regular menstrual cycles Age 18-50 Normal baseline ultrasound No intrauterine procedures in prior 90 days Exclusions: The following are exclusion criteria: Any contraindications to undergoing estrogen stimulation of the endometrium Current smoking status Multiple risk factors for arterial cardiovascular disease (smoking, diabetes, and hypertension) Hypertension (systolic ≥140 mmHg or diastolic ≥90 mmHg) Venous thromboembolism (current or history of) Known thrombogenic mutations Known ischemic heart disease History of stroke Complicated valvular heart disease (pulmonary hypertension, risk for atrial fibrillation, history of subacute bacterial endocarditis) Systemic lupus erythematosus (positive or unknown antiphospholipid antibodies) Migraine with aura at any age Breast cancer Cirrhosis Hepatocellular adenoma or malignant hepatoma History of infertility diagnosis History of undiagnosed abnormal uterine bleeding. Allergic reaction to any medication used for the preparatory cycle Known pregnancy or delivery within the past 6 months Breastfeeding Obesity >35 kg/m2 Phase 2 Major Inclusion: The following are major inclusion criteria: Age 18-50 Diagnosis of infertility with low endometrial risk No intrauterine procedures in prior 90 days Exclusions: In addition to the exclusion criteria for phase 1, patients deemed to have an elevated endometrial risk will also be excluded. This would include the following: Recurrent implantation failure Failed transfer with a euploid blastocyst History of Asherman's or abnormal endometrial function History of endometriosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy volunteers without infertility<br>Healthy volunteers without a history of infertility who have regular menstrual cycles and whom have not had any intrauterine procedures performed in the last 90 days prior to participation in the study | Other: Endometrial biopsy<br>* All groups will undergo a mock frozen embryo transfer cycle with an endometrial biopsy being performed as opposed to an embryo transfer<br>|
| Infertile Patients<br>Infertile patients with a history of infertility but without concern for endometrial dysfunction as the cause of their infertility. | Other: Endometrial biopsy<br>* All groups will undergo a mock frozen embryo transfer cycle with an endometrial biopsy being performed as opposed to an embryo transfer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transcriptomic evaluation | evaluation to characterize genes expressed during the window of implantation | 90 days |