Serum Progesterone on the Day of Embryo Transfer and Pregnancy Rate.

January 30, 2019 updated by: Elena Labarta, Instituto Valenciano de Infertilidad, IVI VALENCIA

Impact of Serum Progesterone Levels on the Day of Embryo Transfer in Artificial Endometrial Preparation Cycles on the Ongoing Pregnancy Rate.

This study aims to analyze whether serum Progsterone levels on the day of Embryo Transfer are related with Ongoing Pregnancy rate in artificial endometrial preparation cycles with intravaginal micronized progesterone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1205

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
        • Instituto Valenciano de Infertilidad Spain

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

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women who are undergoing IVF treatments with artificial endometrial preparation with hormonal replacement therapy.

Description

Inclusion Criteria

  1. Age <50 years old

  2. Hormonal Replacement therapy cycle for embryo transfer in any of the following situations:

    1. Embryos in fresh cycle with donated oocytes.
    2. Subsequent embryo transfers of vitrified embryos in cycles of donated oocytes.
    3. Frozen embryo transfers in cycles with autologous oocytes.
  3. Endometrial line: >6.5-7mm (with trilaminar aspect) in proliferative phase, before introducing progesterone.
  4. Administration of natural micronized progesterone intravaginally (400 mg/12 hours for 5 complete days (10 dosis), before the embryo transfer and maintained until pregnancy week 12.
  5. Embryo transfer of blastocyst (day 5-6).
  6. Signed Informed Consent

Exclusion Criteria

  1. Uterine pathology (submucous o intramural fibroids (>4 cm) or which deform the uterine cavity; endometrial polyps or Müllerian anomalies; or adnexal anomalies (communicating hydrosalpinx).
  2. Simultaneous participation in another clinical study.
  3. Participation in another clinical study before the inclusion in the present study, and which could affect the objectives of the present study.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of serum Progesterone levels
Time Frame: The day of embryo transfer
Serum progesterone levels
The day of embryo transfer
Ongoing Pregnancies depending on Progesterone levels ranges.
Time Frame: Week 5-12 after Embryo Transfer
Ultrasound to confirm Ongoing Pregnancy
Week 5-12 after Embryo Transfer

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 (Actual)

September 8, 2017

Primary Completion (Actual)

November 28, 2018

Study Completion (Actual)

November 28, 2018

Study Registration Dates

First Submitted

August 31, 2017

First Submitted That Met QC Criteria

September 1, 2017

First Posted (Actual)

September 5, 2017

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 30, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1704-VLC-024-EL

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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