Transcriptomic Evaluation of Endometrial Receptivity

NCT ID: NCT04141085

Last Updated: 2023-05-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 63 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-28
• Study Completion Date: 2022-12-15

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.

Conditions

Infertility, Female

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy volunteers without infertility

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

Endometrial biopsy

Intervention Type: OTHER

All groups will undergo a mock frozen embryo transfer cycle with an endometrial biopsy being performed as opposed to an embryo transfer

Infertile Patients

Infertile patients with a history of infertility but without concern for endometrial dysfunction as the cause of their infertility.

Endometrial biopsy

Intervention Type: OTHER

All groups will undergo a mock frozen embryo transfer cycle with an endometrial biopsy being performed as opposed to an embryo transfer

Interventions

Endometrial biopsy

All groups will undergo a mock frozen embryo transfer cycle with an endometrial biopsy being performed as opposed to an embryo transfer

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Regular menstrual cycles

2. Age 18-50

3. Normal baseline ultrasound

4. No intrauterine procedures in prior 90 days

1. Age 18-50

2. Diagnosis of infertility with low endometrial risk

3. No intrauterine procedures in prior 90 days

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

1. Recurrent implantation failure

2. Failed transfer with a euploid blastocyst

3. History of Asherman's or abnormal endometrial function

4. History of endometriosis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Reproductive Medicine Associates of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard T Scott, MD

Role: PRINCIPAL_INVESTIGATOR

Reproductive Medicine Associates of New Jersey

Locations

Reproductive Medicine Assoicates of New Jersey

Basking Ridge, New Jersey, United States

Countries

United States

Other Identifiers

RMA-2019-01

Identifier Type: -

Identifier Source: org_study_id