Hormonal Effects on the Uterus and Endometrium

NCT00001454 | Completed

• 2 other identifiers: 95011095-CH-0110
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

Endometrium is the lining of the uterus. It is where the fertilized egg normally implants during pregnancy. This study was designed to better understand the way(s) that female sex hormones (estrogen and progesterone) cause the uterus to grow and develop. It is known that these hormones are necessary to prepare the uterus for pregnancy, but the way the hormones work is unknown. Researchers would like to identify the genes that are affected by female sex hormones by using a variety of tests (in situ hybridization, immunohistochemistry, and culture of human endometrium). Researchers will select women who have regular monthly menstrual cycles and study them for two cycles;

1. 1.\<TAB\>The first cycle (PRE-BIOPSY CYCLE) will include daily measurements of the patient's body temperature and progesterone measurements during the last 14 days (luteal phase) of the menstrual cycle.
2. 2.\<TAB\> The second cycle (BIOPSY CYCLE) will include measurements of urinary luteinizing hormone (LH) to determine the day of the LH surge. Luteinizing hormone is the hormone that causes the ovary to release the developed egg. Ovarian ultrasounds will be performed before the biopsy to determine development of the egg. Blood tests will be taken on the day of the biopsy to have an overall idea of the hormones circulating in the patient's blood. An endometrial biopsy will be taken at one of three possible times to identify endometrial products under conditions of estrogen, estrogen/progesterone, or steroid hormone withdrawal.\<TAB\>

Conditions

Pregnancy

Keywords

Estrogen; Progesterone; Menses; Endometrium; Normal Volunteer

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Sokolov BP, Prockop DJ. A rapid and simple PCR-based method for isolation of cDNAs from differentially expressed genes. Nucleic Acids Res. 1994 Sep 25;22(19):4009-15. doi: 10.1093/nar/22.19.4009.

  PMID: 7524031 BACKGROUND

• Jones GS. The clinical evaluation of ovulation and the luteal phase. J Reprod Med. 1977 Mar;18(3):139-42. No abstract available.

  PMID: 853495 BACKGROUND

• Batista MC, Cartledge TP, Merino MJ, Axiotis C, Platia MP, Merriam GR, Loriaux DL, Nieman LK. Midluteal phase endometrial biopsy does not accurately predict luteal function. Fertil Steril. 1993 Feb;59(2):294-300.

  PMID: 8425621 BACKGROUND

Study Officials

• Lynnette K Nieman, M.D.

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: April 21, 1995
• Study Completion: July 27, 2015
• Last Updated: December 16, 2019

Record last verified: 2015-07-27

Locations

US (1)