Completed

Endometrial Mediators of Gonadal Steroid Action

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What is being collected

Data Collection

Who is being recruted

From 18 to 43 Years
See all eligibility criteria
How is the trial designed

Observational
Study Start: April 1995
See protocol details

Summary

Principal SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Last updated: December 16, 2019
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Study start date: April 21, 1995

Actual date on which the first participant was enrolled.

Estrogen and progesterone induce characteristic and predictable morphological changes in the endometrium that are required for successful implantation and pregnancy. The mechanism(s) by which estrogen and progesterone exert these effects on the endometrium is not known. This is a tissue collection protocol to obtain endometrium and/or menstrual effluent from normally cycling women, women with endometriosis and women with infertility. This tissue will be used for future studies intended to understand gonadal steroid action on the endometrium We propose to identify peptides that are induced by endogenous estrogen and progesterone using in situ hybridization, immunohistochemistry, microarray analysis and/or culture of human endometrium obtained at hormonally different times of the cycle. Regularly cycling women not at risk for pregnancy will be studied for two menstrual cycles. The first, pre-biopsy cycle, will be characterized by daily basal body temperature measurements and a luteal phase progesterone measurement. During the biopsy cycle, urinary LH measurements will be performed to determine the day of the LH surge. Ovarian ultrasounds to assess follicular development will be performed before biopsy. Blood will be obtained on the day of the biopsy to characterize the hormonal mileau. An endometrial biopsy will be obtained either in the early follicular phase (at a follicular diameter of less than 8 mm), the late follicular phase (follicular diameter greater than 14 mm) or in the mid-(luteal phase day 6-8) or late (luteal phase day 12 - 14) luteal phase, to allow identification of endometrial products under conditions of estrogen, estrogen/progesterone and steroid withdrawal. Alternatively, endometrial tissue may be obtained from normal women and those with endometriosis at the time of menses using a cup-shaped intravaginal collecting device. Additionally, women with infertility possibly related to endometrial dysfunction will be studied in the luteal phase.

NCT00001454
Principal SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Last updated: December 16, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

129 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 43 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

INCLUSION CRITERIA: Healthy volunteers will be in excellent health. Only women with regular menstrual cycles (every 26-35 days) using mechanical (condoms, diaphragm) or sterilization methods of contraception will be included. Only women with a negative pregnancy test, normal physical examination and laboratory results, and a luteal phase progesterone value of greater than 4 ng/mL will be entered into this study. Women with endometriosis will be recruited from those with histologically-proven endometriosis. Except for this diagnosis they will meet criteria for healthy volunteers as stated above. Women may participate in the study on more than one occasion, but biopsies may not be performed in a "baseline" cycle.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps
CompletedOne Study Center