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NCT04939064 · ClinicalTrials.gov registry record
Endometrial Basis for Infertility in Women With Recurrent Implantation Failure and Pregnancy Loss
A clinical trial, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Terminated
- Registry status
- 3
- Enrollment target
NCT04939064: Clinical Trial study, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT04939064 is a clinical trial that was terminated before completion, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 3 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04939064 was terminated before completion, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- TERMINATED
- Registry status
- 3 participants
- Enrollment target
Study Summary
Background: Pregnancy loss is the most common complication of pregnancy. It occurs in roughly one-half of natural conceptions. It most frequently occurs in the first 2 to 3 weeks of pregnancy. Researchers want to look at the lining of the uterus, called the endometrium, to see what role it plays in implantation and miscarriage. Objective: To gain a better understanding of how normal and abnormal endometrium works. Eligibility: Healthy, fertile women ages 18-42 who have had one prior child. Design: Participants will have 3 study visits. At visit 1, participants will have a medical history. They will have a radiologic/imaging review if needed. They will be taught how to monitor their urine luteinizing hormone (LH) at home with an ovulation predictor kit. They will have their second study visit 9 days after their LH surge. At visit 2, participants will take a urine pregnancy test. They will have a physical exam and have blood drawn. They will have a uterine lavage and endometrial biopsy. For this, a speculum will be placed into the vagina. A soft catheter will be inserted through the cervical canal into the uterus. Saline will be added into the uterus and then recovered after 30 seconds. A tissue sample will be taken. About 46 days later, participants will start another round of LH monitoring. They will have a third study visit 9 days after their LH surge. At visit 3, they will repeat the tests from visit 2. Some samples will be used for genetic tests. Participation will last for 3 menstrual cycles. ...
Primary Outcome
This aim hypothesizes that the endometrium of fertile women has intrinsic differences in cell types and cell-specific gene expression compared to infertile women with clinically-defined early pregnancy loss. Cohorts of fertile women (controls) and infertile women with EIF, EPF or RPL (cases) will be recruited and sampled. Endometrial biopsies will be obtained from the women during the mid-secretory phase (LH+7-9) of their cycle. Single nuclei RNA-seq (snRNA-seq) will be employed to define the tr
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2022-09-30 |
| Est. Completion | 2023-12-05 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
Why NCT04939064 stopped before completion
NCT04939064 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 3 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT04939064 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04939064 about?
NCT04939064 is a clinical study titled "Endometrial Basis for Infertility in Women With Recurrent Implantation Failure and Pregnancy Loss". Background: Pregnancy loss is the most common complication of pregnancy. It occurs in roughly one-half of natural conceptions. It most frequently occurs in the first 2 to 3 weeks of pregnancy. Researchers want to look at the lining of the uterus, called the endometrium, to see what role it plays i...
What is the current status of trial NCT04939064?
This trial is currently terminated. The enrollment target is 3 participants. The study started on 2022-09-30. Estimated completion is 2023-12-05.
Who is sponsoring clinical trial NCT04939064?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
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