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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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-009429-26-BE
Enrollment
Unknown
Registered
2009-03-02
Start date
2010-03-15
Completion date
Unknown
Last updated
2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: Pregnyl 1500 IU Product Name: Pregnyl 1500 IU Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: choriongonadotrofine (hCG) Concentration unit: IU inte

Sponsors

FREE UNIVERSITY OF BRUSSELS
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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: 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. 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. 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).

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026