Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to comprehensively evaluate the transcriptomic signal of the endometrium before, during, and after the window of receptivity.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| Infertile Patients | Infertile patients with a history of infertility but without concern for endometrial dysfunction as the cause of their infertility. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| transcriptomic evaluation | evaluation to characterize genes expressed during the window of implantation | 90 days |
Not provided
Not provided
Phase 1:
Major Inclusion: The following are major inclusion criteria:
Exclusions: The following are exclusion criteria:
Any contraindications to undergoing estrogen stimulation of the endometrium
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:
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:
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Richard T Scott, MD | Reproductive Medicine Associates of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reproductive Medicine Assoicates of New Jersey | Basking Ridge | New Jersey | 07920 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| D000091662 | Genital Diseases |
| D007246 | Infertility |