Transcriptomic Evaluation of Endometrial Receptivity

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

Study Overview

• Status: Completed
• Conditions: Infertility, Female
• Intervention / Treatment: Other: Endometrial biopsy

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.

• Study Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Reproductive Medicine Assoicates of New Jersey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Phase 1:

Healthy volunteers without a history of infertility will be recruited for the first phase to undergo an endometrial biopsy on a randomized cycle day surrounding the window of implantation

Phase 2:

Healthy volunteers with a history of infertility but without concern for endometrial dysfunction will be recruited for the second phase to undergo an endometrial biopsy during a preparatory IVF cycle.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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
Infertile Patients; Infertile patients with a history of infertility but without concern for endometrial dysfunction as the cause of their infertility.	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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Reproductive Medicine Associates of New Jersey
• Investigators: Principal Investigator: Richard T Scott, MD, Reproductive Medicine Associates of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2020
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: October 24, 2019
• First Submitted That Met QC Criteria: October 24, 2019
• First Posted (Actual): October 28, 2019

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: RMA-2019-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No