Transcriptomic Evaluation of Endometrial Receptivity

Infertility, Female Clinical Trial

Official title:

Transcriptomic Evaluation of Endometrial Receptivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04141085
• Other study ID #: RMA-2019-01
• Status: Completed
• Start date: January 28, 2020
• Est. completion date: December 15, 2022

Study information

• Verified date: May 2023
• Source: Reproductive Medicine Associates of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to comprehensively evaluate the transcriptomic signal of the endometrium before, during, and after the window of receptivity.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 15, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 exclusion criteria for phase 1, patients deemed to have an

elevated endometrial risk will also be excluded. This would include the following:

1. Recurrent implantation failure

2. Failed transfer with a euploid blastocyst

3. History of Asherman's or abnormal endometrial function

4. History of endometriosis

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

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

Locations

Country	Name	City	State
United States	Reproductive Medicine Assoicates of New Jersey	Basking Ridge	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive Medicine Associates of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	transcriptomic evaluation	evaluation to characterize genes expressed during the window of implantation	90 days