Early Progesterone Cessation After in Vitro Fertilization

April 5, 2024 updated by: Graciela Kohls, IVI Madrid
There seems to be a general consensus on the supplementation of progesterone (P4) for luteal phase support (LPS) to all women after in vitro fertilization (IVF) treatment. However, there is no agreement about the precise duration of LPS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of the study is to investigate the effect of early cessation of progesterone for LPS after IVF treatment on the pregnancy outcome, with special interest in determining the miscarriage rate and episodes of bleeding between the date of the first ultrasound (US) and up to 12 weeks of gestation.

Patients start to receive 200 mg twice a day of P4 on the day after oocyte retrieval.

All patients which show a gestational sac in their uterus in the first US are included in this study and randomized.

Inclusion criteria:

  1. Patients who underwent ovarian stimulation using GnRH analogues,
  2. Fresh embryo transfer,
  3. LPS by vaginal micronized P4,
  4. Clinical pregnancy demonstrated by US and
  5. Informed consent signed.

Exclusion criteria:

Patients who had bleeding episodes before their first US because they are likely to continue P4 therapy without medical indication.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

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
      • Madrid, Spain, 28023
        • IVI-Madrid

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 40 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients who underwent ovarian stimulation using GnRH analogues,
  2. Fresh embryo transfer,
  3. LPS by vaginal micronized P4,
  4. Clinical pregnancy demonstrated by US and
  5. Informed consent signed.

Exclusion Criteria:

Patients who had bleeding episodes before their first US because they are likely to continue P4 therapy without medical indication.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Progesterone 5 Weeks
The study group stop receiving P4 on the day of their first US at 5 weeks pregnancy
Other: Cease progsterone at 5
Cease administration of progsterone at first US at 5 weeks
Other: Control Group : P4 8 weeks
Progesterone will be given until 8 weeks of pregnancy
Other: control group: progesterone 8
Control group: progesterone until 8 weeks of pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Bleeding Episodes
Time Frame: Up to year
Number of bleeding episodes up to a year
Up to year

Collaborators and Investigators

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

Sponsor

IVI Madrid

Investigators

  • Study Director: Juan A Garcia-Velasco, MD, PhD, IVI Madrid

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

January 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

August 5, 2010

First Submitted That Met QC Criteria

August 6, 2010

First Posted (Estimated)

August 9, 2010

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAD-GK-01-2009-02

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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