Assessment of Endometrial Receptivity in Recipients of Donated Oocytes

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
Phase 1 Study of Endometrial Markers of Endometrial Receptivity in Oocyte Donation

Conditions
-----------------
Embryo Implantation

Intervention / Treatment
-----------------
* Procedure: endometrial sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for IVF or OD Exclusion Criteria: Cervical stenosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 51 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OD<br>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<br>* 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.<br>|
| Experimental: IVF<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| embryo implantation |  | 1 MONTH | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Embryo Implantation, Endometrium, endometrial implantation, Oocyte Donation, in vitro fertilization, endometrial sampling