Progesterone Levels and Clinical Outcomes Using a Single Pessary of 400 mg of Vaginal Progesterone in Substitutive Cycles for Embryo Transfer. (CycloCT)

March 17, 2021 updated by: Joaquín Llácer, Instituto Bernabeu

This study aims to compare the efficacy, in terms of progesterone levels and clinical outcomes, of two different presentations of micronized vaginal progesterone (400 mg vs. 200 mg) used in endometrial preparation in artificial cycle (AC) for embryo transfer.

This is a non-inferiority, retrospective case-control study, with at least 200 cycles analyzed (at least 100 per arm) and the primary outcome is the serum progesterone level on the day of the embryo transfer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

347

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
    • Comunidad Valenciana
      • Alicante, Comunidad Valenciana, Spain, 03016
        • Instituto Bernabeu

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 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The population will be selected among those patients who have undergone embryo transfer treatment with endometrial preparation in a artificial cycle at the Instituto Bernabeu.

Description

Inclusion Criteria:

  • Patients with primary or secondary infertility undergoing endometrial preparation for an embryo transfer using standard doses of oral or transdermal estrogens.
  • Age between 18 and 50 years.
  • Normal uterine cavity verified by imaging techniques.
  • Serum progesterone documented on the day of embryo transfer.

Exclusion Criteria:

  • Patients with a history of endometritis.
  • Patients diagnosed with Asherman's syndrome.
  • Patients with a different supplementation regimen or doses than those of the study groups.

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: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
400 mg
Treatments where 400 mg tablet presentation of micronized vaginal progesterone was used, the protocol being one vaginal tablet twice a day.
Drug: Vaginally administered progesterone
The artificial endometrial preparation for an embryo transfer with the use of 400 mg vaginal tablet (one tablet twice a day) or 200 mg (two tablets twice a day)
200 mg
Treatments where 200 mg tablet presentation of micronized vaginal progesterone was used, the protocol being two vaginal tablets twice a day.
Drug: Vaginally administered progesterone
The artificial endometrial preparation for an embryo transfer with the use of 400 mg vaginal tablet (one tablet twice a day) or 200 mg (two tablets twice a day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum progesterone level
Time Frame: On the day of embryo transfer
On the day of embryo transfer

Secondary Outcome Measures

Outcome Measure
Time Frame
Need for additional progesterone supplementation
Time Frame: assessed on the day of the embryo transfer
assessed on the day of the embryo transfer
Clinical results (ongoing pregnancy and miscarriage rate)
Time Frame: assessed on the day of the pregnancy test and during the pregnancy evolution
assessed on the day of the pregnancy test and during the pregnancy evolution

Collaborators and Investigators

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

Sponsor

Instituto Bernabeu

Investigators

  • Principal Investigator: Joaquín Llácer, MD PhD, Instituto Bernabeu

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)

March 3, 2021

Primary Completion (Actual)

March 3, 2021

Study Completion (Actual)

March 17, 2021

Study Registration Dates

First Submitted

January 21, 2021

First Submitted That Met QC Criteria

January 21, 2021

First Posted (Actual)

January 25, 2021

Study Record Updates

Last Update Posted (Actual)

March 19, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IB-1201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The information collected in the study will always be treated as grouped data and never as individual or personal data, thus maintaining anonymity and confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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