Transcriptomic Evaluation of Endometrial Receptivity

NCT04141085 | Completed

• 1 other identifier: RMA-2019-01
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

• transcriptomic evaluation

  evaluation to characterize genes expressed during the window of implantation

  90 days

Study Arms (2)

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

Infertile Patients

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

Other: Endometrial biopsy

Interventions

Endometrial biopsy OTHER

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

Healthy volunteers without infertility; Infertile Patients

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Regular menstrual cycles
• Age 18-50
• Normal baseline ultrasound
• No intrauterine procedures in prior 90 days

You may not qualify if:

• 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

Sponsors & Collaborators

• Reproductive Medicine Associates of New Jersey: lead

Study Sites (1)

Reproductive Medicine Assoicates of New Jersey

Basking Ridge, New Jersey, 07920, United States

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Richard T Scott, MD

  Reproductive Medicine Associates of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: October 28, 2019
• Study Start: January 28, 2020
• Primary Completion: January 31, 2022
• Study Completion: December 15, 2022
• Last Updated: May 3, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)