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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2007 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00506480
First Posted: July 25, 2007
Last Update Posted: February 5, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  Purpose
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.

Condition Intervention
Embryo Implantation Procedure: endometrial sampling

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase 1 Study of Endometrial Markers of Endometrial Receptivity in Oocyte Donation

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • embryo implantation [ Time Frame: 1 MONTH ]

Estimated Enrollment: 100
Study Start Date: August 2007
Arms Assigned Interventions
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.
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: 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.
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.

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 51 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for IVF or OD

Exclusion Criteria:

  • Cervical stenosis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00506480


Contacts
Contact: Ariel Revel, MD 97226777111 ext 76424 arielr2@hadassah.org.il
Contact: Alex Simon, MD 97226777111 ext 77174 asimon@md.huji.ac.il

Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Ariel Revel, MD Hadassah
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00506480     History of Changes
Other Study ID Numbers: 319-08.07
First Submitted: July 22, 2007
First Posted: July 25, 2007
Last Update Posted: February 5, 2010
Last Verified: July 2007

Keywords provided by Hadassah Medical Organization:
Embryo Implantation
Endometrium
endometrial implantation
Oocyte Donation
in vitro fertilization
endometrial sampling