Assessment of Endometrial Receptivity in Recipients of Donated Oocytes (ERPOD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00506480
First received: July 22, 2007
Last updated: February 4, 2010
Last verified: July 2007

July 22, 2007
February 4, 2010
August 2007
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embryo implantation [ Time Frame: 1 MONTH ]
Same as current
Complete list of historical versions of study NCT00506480 on ClinicalTrials.gov Archive Site
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Assessment of Endometrial Receptivity in Recipients of Donated Oocytes
Phase 1 Study of Endometrial Markers of Endometrial Receptivity in Oocyte Donation

The purpose of this study is to determine whether endometrial receptivity markers obtained by endometrial sampling are effective in prediction of in vivo human embryo implantation.

Since the introduction of In vitro fertilization (IVF), substantial improvements have been developed in ovulation induction, oocyte retrieval, fertilization capability and embryonic development. However, the end point which is to improve implantation and pregnancy rates after transferring embryos, remains below physiological expectations. It has been estimated that clinical implantation in the human is efficient in no more than 30% of cases considering that only one embryo is present in natural cycles, which gives us a 30% implantation rate.

A frequent pitfall found in the literature is the consideration that implantation is the result of good embryonic quality. Although this is completely true, it is not the only truth because the maternal endometrium is at least of equal relevance. In ovum donation, the endometrial factor could also be improved by individualizing the implantation window in each patient. In this proposed research we will analyze suggested markers of endometrial receptivity in order to optimize human implantation in patients undergoing assisted reproductive technologies focusing on improving endometrial receptivity in IVF and ovum donation patients.

Interventional
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Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Embryo Implantation
Procedure: endometrial sampling
Endometrial biopsy is a procedure in which a tissue sample is obtained from the endometrium. This procedure is performed without anesthesia during pelvic examination. The cervix is cleaned with an antiseptic solution and then grasped with an instrument (tenaculum) to steady the uterus. A small, hollow plastic tube is gently passed into the uterine cavity. Gentle suction removes a sample of the lining. The tissue sample and instruments are removed, and the sample is examined by pathology, immunohistochemistry, PCR and western blotting.
  • Experimental: OD
    patients artificially prepared for OD will undergo a mock cycle consisting of estrogen and later by progesterone. a pipelle sample will be taken after 6 days of progesterone supplementation.
    Intervention: Procedure: endometrial sampling
  • Experimental: IVF
    A pipelle sample will be taken on day 21 of the cycle before administration of GNRHa. Exact timing will be performed by counting 7 days from the LH surge.
    Intervention: Procedure: endometrial sampling
Achache H, Revel A. Endometrial receptivity markers, the journey to successful embryo implantation. Hum Reprod Update. 2006 Nov-Dec;12(6):731-46. Epub 2006 Sep 18. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
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Inclusion Criteria:

  • Patients scheduled for IVF or OD

Exclusion Criteria:

  • Cervical stenosis
Female
18 Years to 51 Years
No
Contact: Ariel Revel, MD 97226777111 ext 76424 arielr2@hadassah.org.il
Contact: Alex Simon, MD 97226777111 ext 77174 asimon@md.huji.ac.il
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NCT00506480
319-08.07
No
Not Provided
Hadassah Medical Organization
Not Provided
Principal Investigator: Ariel Revel, MD Hadassah
Hadassah Medical Organization
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP