NCT04939064

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

Terminated Last updated 22 March 2024

What this trial tests

trial in Normal Endometrial Physiology in 3 participants. Terminated before completion.

Timeline

30 September 2022

Primary endpoint
5 December 2023

5 December 2023

Quick facts

Lead sponsor	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	3
Start date	30 September 2022
Primary completion	5 December 2023
Estimated completion	5 December 2023
Sites	1 location across United States

Conditions studied

• Normal Endometrial Physiology — all drugs for Normal Endometrial Physiology →

Sponsor

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

Who can join

Adults 18 to 42, female only, with Normal Endometrial Physiology. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

...

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Harnessing induced pluripotent stem cells and organoids for disease modeling and precision medicine.
   Lee CJ, Nam Y, Rim YA, Ju JH. · · 2026 · PMID 41656303 · DOI 10.1186/s13287-026-04906-9