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

November 28, 2016 updated by: Elena Labarta, Instituto Valenciano de Infertilidad, IVI VALENCIA

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

242

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
      • Valencia, Spain, 46015
        • IVI Valencia

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

25 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Infertile patients undergoing their first or second egg donation cycle

Description

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 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
P25-P75
serum progesterone between 25 and 75 percentile
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
<P25 ó >P75
serum progesterone <25 or >75 percentile
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mid-luteal serum progesterone level
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
endometrial volume
Time Frame: one year
one year

Collaborators and Investigators

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

Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

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

February 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

February 16, 2016

First Submitted That Met QC Criteria

February 25, 2016

First Posted (Estimate)

March 2, 2016

Study Record Updates

Last Update Posted (Estimate)

November 29, 2016

Last Update Submitted That Met QC Criteria

November 28, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1511-VLC-061-EL
  • IVI-EST-2015-01 (Other Identifier: CAEPO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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