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Endometrial Basis for Infertility in Women With Recurrent Implantation Failure and Pregnancy Loss

NCT04939064 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 3

Last updated 2024-03-22

No results posted yet for this 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.

...

Conditions

  • Normal Endometrial Physiology

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    lead NIH

Principal Investigators

  • Laverne G Mensah, M.D. · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2023-12-05
Completion
2023-12-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04939064 on ClinicalTrials.gov