A PILOT STUDY TO EVALUATE THE EFFECT OF TRIGGERING FINAL OOCYTE MATURATION WITH GnRHa OR hCG ON ENDOMETRIAL RECEPTIVITY PARAMETERS AND THE LUTEAL PHASE IN OOCYTE DONORS - GnRHa vs hCG: impact on endometrial receptivity

Phase 1

Conditions: Compare the endometrium of oocyte donors, who had final oocyte maturation with either hCG, Suprefact, followed by hCG 35 hours after triggering, Suprefact or Suprefact without luteal phase support.Group A, B, C receive luteal phase support for 5 days, until the day of endometrial sampling (OPU+5).To avoid inter-patient variation in endometrial histology, each patient will preferably perform 4 consecutive oocyte donation cycles, within one year, using models A-D for final oocyte maturation

Registration Number: EUCTR2009-009429-26-BE

Lead Sponsor: FREE UNIVERSITY OF BRUSSELS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

• All patients qualifying as oocyte donors i.e.
• A minimum of 5-10 antral follicles in each ovary
• Normal genetic analysis
• Normal caryotype
• Normal serological findings within 3 months prior to stimulation
• Normal vaginal ultrasound
• No IUD

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• PCOS (Rotterdam criteria)
• Age = 36 years
• BMI = 30
• Severe endometriosis
• Hydrosalpinges, visible at ultrasound

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: comparison of endometrial status after different types of final oocyte maturation;Secondary Objective: ;Primary end point(s): Study groups A, B, C and D:<br>Histological markers (Noyes criteria) in all samples as well as gene expression in a subset of each group. A set of classical implantation markers can be added, ie osteopontin, glycodelinA, Dickkopf, transcobalamin, dipeptidilpeptidase IV. Differentially expressed genes in the three groups can be further explored and compared to already known implantation factors.<br>Progesterone-receptor, LH-receptor expression and oestradiol-receptor expression, possibly performed with quantitative RT-PCR in relation to two or three house-hold genes constantly expressed. <br>Further analysis of gene expression with the Affymetrix HGU133Plus2 microarray. According to previous publications, the significantly up and down regulated genes will be analysed (SERPINB6, FOXO3A, SOX17, and CDC42, NRP1, HOXA10, and OSF2).

Secondary Outcome Measures