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Completed

NCT Number: NCT04141085

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Reproductive Medicine Assoicates of New Jersey

Basking Ridge, New Jersey, 07920, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. transcriptomic evaluation

    Time frame: 90 days

    evaluation to characterize genes expressed during the window of implantation

Sponsors and collaborators

Lead sponsor

Reproductive Medicine Associates of New Jersey

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 28, 2019
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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