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

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.

Study Overview

• Status: Unknown
• Conditions: Embryo Implantation
• Intervention / Treatment: Procedure: endometrial sampling

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ariel Revel, MD; Phone Number: 76424 97226777111; Email: arielr2@hadassah.org.il
• Study Contact Backup: Name: Alex Simon, MD; Phone Number: 77174 97226777111; Email: asimon@md.huji.ac.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients scheduled for IVF or OD

Exclusion Criteria:

• Cervical stenosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
embryo implantation	1 MONTH

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Investigators: Principal Investigator: Ariel Revel, MD, Hadassah

Publications and helpful links

General Publications

• Achache H, Revel A. Endometrial receptivity markers, the journey to successful embryo implantation. Hum Reprod Update. 2006 Nov-Dec;12(6):731-46. doi: 10.1093/humupd/dml004. Epub 2006 Sep 18.

Study record dates

Study Major Dates

• Study Start: August 1, 2007

Study Registration Dates

• First Submitted: July 22, 2007
• First Submitted That Met QC Criteria: July 22, 2007
• First Posted (Estimate): July 25, 2007

Study Record Updates

• Last Update Posted (Estimate): February 5, 2010
• Last Update Submitted That Met QC Criteria: February 4, 2010
• Last Verified: July 1, 2007

More Information

Terms related to this study

• Keywords: in vitro fertilization; Endometrium; Embryo Implantation; endometrial implantation; Oocyte Donation; endometrial sampling
• Other Study ID Numbers: 319-08.07