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NCT02696694 Clinical Trial

Predictive Value of Mid-luteal Serum Progesterone Levels in Egg Donation Cycles

Pregnancy Clinical Trial

Official title:
Impact of Serum Progesterone Levels on the Day of Embryo Transfer on the Success Rate in Egg Donation Cycles Under Hormonal Replacement

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02696694
Other study ID # 1511-VLC-061-EL
Secondary ID IVI-EST-2015-01
Status Completed
Phase N/A
First received February 16, 2016
Last updated November 28, 2016
Start date February 2016
Est. completion date October 2016

Study information
Verified date November 2016
Source Instituto Valenciano de Infertilidad, IVI VALENCIA
Contact n/a
Is FDA regulated No
Health authority Spain: Agencia Española de Medicamentos y Productos Sanitarios
Study type Observational

Clinical Trial Summary

This study aims to investigate the impact of serum progesterone concentrations on the day of embryo transfer in egg donation cycles under hormonal replacement therapy. As secondary outcomes, the investigators will investigate if endometrial volume measured by three-dimensional (3D) ultrasound on the day of embryo transfer is related with progesterone levels and with chances of pregnancy.

Recruitment information / eligibility
Status Completed
Enrollment 242
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 50 Years
Eligibility Inclusion Criteria:

- Age<50 yo

- BMI < 30Kg/m2

- Hormonal replacement cycle

- Endometrial thickness >6.5 mm during proliferative phase

- Transfer of one or two blastocyst grade A-B according to ASEBIR

Exclusion Criteria:

- Uterine pathology

- Cryptozoospermia

- Severe implantation failure (>6 GQ embryos transferred without success)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Progesterone 25-75
Impact of serum progesterone concentrations [25-75] on the day of embryo transfer in egg donation cycles under hormonal replacement therapy
• Progesterone <25, >75
Impact of serum progesterone concentrations (<25, >75) on the day of embryo transfer in egg donation cycles under hormonal replacement therapy

Locations
Country Name City State
Spain IVI Valencia Valencia

Sponsors (1)
Lead Sponsor Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary mid-luteal serum progesterone level one year No
Secondary endometrial volume one year No
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