Progesterone Variation on the Final Day of Oocyte Maturation.

April 3, 2018 updated by: Nikolaos Polyzos, Institut Universitari Dexeus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08028
        • Salud de la Mujer Dexeus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Healthy oocyte donors according to spanish law for oocyte donation

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Oocyte donors
Healthy oocyte donors undergoing ovarian stimulation with recombinant Follicular stimulating hormone
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progesterone variation among 4 different moments on the day of ovulation triggering
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Universitari Dexeus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2017

Primary Completion (ACTUAL)

January 25, 2018

Study Completion (ACTUAL)

January 25, 2018

Study Registration Dates

First Submitted

November 28, 2017

First Submitted That Met QC Criteria

December 7, 2017

First Posted (ACTUAL)

December 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 4, 2018

Last Update Submitted That Met QC Criteria

April 3, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMD-VPD-2017-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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