Progesterone Variation on the Final Day of Oocyte Maturation.

Circadian Rhythm Clinical Trial

Official title:

Progesterone Variation on the Final Day of Oocyte Maturation. A Prospective Cohort Study With Repeated Measurements

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03366025
• Other study ID #: SMD-VPD-2017-03
• Status: Completed
• First received: November 28, 2017
• Last updated: April 3, 2018
• Start date: November 1, 2017
• Est. completion date: January 25, 2018

Study information

• Verified date: April 2018
• Source: Institut Universitari Dexeus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The current study, aims through a robust design to provide a simple answer on whether progesterone levels of the same individual may significantly vary depending on the time of blood retrieval before the ovulation triggering, by evaluating the daily variability of serum progesterone on the day of triggering in healthy women who perform a COS for oocyte donation, through multiple blood samplings.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 25, 2018
• Est. primary completion date: January 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Healthy oocyte donors according to spanish law for oocyte donation

• Controlled ovarian stimulation following a flexible antagonist protocol and stimulation with recombinant Follicular stimulating hormone.

• Informed consent signed

Exclusion Criteria:

• Detection of luteinizing hormone surge before triggering

Related Conditions & MeSH terms

• Circadian Rhythm
• Controlled Ovarian Stimulation
• Oocyte Donors
• Progesterone Variation on Trigger Day

Intervention

Diagnostic Test:
• Serum progesterone measure
Serum Progesterone will be measured in all donors on the day triggering at 8:00 am, 12:00 p, 16:00 pm and 20:00 pm

Locations

Country	Name	City	State
Spain	Salud de la Mujer Dexeus	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Institut Universitari Dexeus

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progesterone variation among 4 different moments on the day of ovulation triggering	Measurement of serum Progesterone (ng/ml) in each oocyte donor at 4 different times on the day of ovulation triggering: The primary outcome will be the variation among the 4 progesterone measurements for each patient within the fixed12 hours time (8:00am; 12:00pm; 4:00pm and 8:00pm).	Progesterone will be measured 4 times on the day of ovulation triggering, each of them separated 4 hours from the previous one (total 4 samples within 12 hours): blood samples will be obtained at 8:00 am, 12:00 pm, 4:00 pm and 08:00 pm