Assessment of Endometrial Receptivity in Recipients of Donated Oocytes - Full Text View

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:	Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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.

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

Ages Eligible for Study:	18 Years to 51 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients scheduled for IVF or OD

Exclusion Criteria:

Cervical stenosis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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:

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.

ClinicalTrials.gov Identifier:	NCT00506480 History of Changes
Other Study ID Numbers:	319-08.07
Study First Received:	July 22, 2007
Last Updated:	February 4, 2010
Health Authority:	Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:

Embryo Implantation
Endometrium
endometrial implantation

Oocyte Donation
in vitro fertilization
endometrial sampling

Additional relevant MeSH terms:

Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013

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