Vaginal Versus Combined Use of Progesterone in Fresh IVF/ICSI Cycles

October 10, 2021 updated by: Nikos Vlahos, University of Athens
Hypothesis: the combined use of progesterone administration for luteal phase support is superior to the single route of progesterone administration in terms of pregnancy outcome parameters in women undergoing fresh IVF/ICSI cycles.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In ART (IVF/ICSI), most of the studies have shown a deficiency of progesterone during the luteal phase, especially due to the use of GnRH analogs. The lack of progesterone leads to abnormal endometrial development and consequently to desynchronization between the latter and the blastocyst implantation. Therefore, it is a standard of care to use progesterone for luteal phase support after embryo transfer and during the first trimester, in case of pregnancy.

According to ESHRE guidelines, either of vaginal, oral, subcutaneous or intramuscular route is advisable.

But, until now, there is no robust evidence on the effect on pregnancy outcome of the combined route of progesterone administration compared to the standard of care (single route).

The aim of this study is to compare the effectiveness of the combined route of progesterone administration to the single route.

The study is a prospective cohort study. Participants will receive either standard treatment with single route (vaginal) progesterone administration according to the ESHRE guidelines, or combination of more than one routes of administration, that is vaginal plus oral or subcutaneous progesterone, starting afterthe fresh embryo transfer until 12 weeks of gestation or a negative pregnancy test.

Study Type

Observational

Enrollment (Anticipated)

698

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Greece
    • Attica
      • Athens, Attica, Greece, 11528
        • Recruiting
        • National and Kapodistrian University of Athens
        • Contact:
        • Contact:

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

22 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Infertile couples with an indication for IVF/ICSI (both Units).

Description

Inclusion Criteria:

  • Patients with a documented history of infertility, aged 22-40, undergoing fresh embryo transfer after IVF/ICSI, under informed consent.
  • Physiological menstrual cycles (24-35 days), normal endocrine function (FSH ≤ 15 IU / ml), transvaginal ultrasound without pathological findings, free personal medical history, indication for IVF/ICSI.

Exclusion Criteria:

  • Endocrine or metabolic disorders, e.g., PCO (S), pathology of the uterus and/or endometrium, basal FSH levels> 15 IU / ml, major surgery in the ovaries (removal), and age <22 years and > 40 years old.
  • Active pelvic inflammatory disease
  • IVF/ICSI with donor eggs
  • Previous participation in this trial

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
combined progesterone group
patients will receive vaginal plus subcutaneous or per os progesterone
Drug: Utrogestan
PROSPECTIVE STUDY
Other Names:
  • PROLUTEX,VASCLOR
Vaginal progesterone group
patients will receive vaginal progesterone
Drug: Utrogestan
PROSPECTIVE STUDY
Other Names:
  • PROLUTEX,VASCLOR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live birth rate
Time Frame: 9 months]
The percentage of viable embryo after 20 weeks of gestation
9 months]
Abortion rate
Time Frame: 20 weeks
Loss of pregnancy up to 20 weeks of gestation
20 weeks

Collaborators and Investigators

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

Sponsor

University of Athens

Collaborators

Iaso Maternity Hospital, Athens, Greece

Investigators

  • Study Director: Nikolaos Vlachos, National and Kapodistrian University of Athens

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 14, 2021

Primary Completion (ANTICIPATED)

February 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

October 10, 2021

First Submitted That Met QC Criteria

October 10, 2021

First Posted (ACTUAL)

October 22, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 22, 2021

Last Update Submitted That Met QC Criteria

October 10, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARETAIEION UNIVERSITY HOSPITAL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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