Administration of Vaginal and Rectal Progesterone During FET Cycles

September 9, 2019 updated by: Thor Haahr

Administration of Vaginal and Rectal Progesterone During Frozen Embryo Transfer Cycles

Observational study of reproductive outcome after frozen embryo transfer in HRT with vaginal and rectal progesterone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cohort of patients treated with autologous blastocyst at the Fertility clinic Skive Regional Hospital in HRT cycle. Estradiol stimulation started on second cycle day and on day 12 - 20 vaginal and rectal progesterone is added. Blastocyst transfer on 6th progesterone treatment day. Serum progesterone and hCG measurement 9 or 11 days after embryo transfer.

Study Type

Observational

Enrollment (Actual)

277

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

  • Denmark
      • Skive, Denmark, 7800
        • Fertility Clinic Regional Hospital Skive

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 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Autologuos spare embryos from previous IVF/ICSI cycles.

Description

Inclusion Criteria:

  • Frozen embryo transfer cycles in HRT cycles

Exclusion Criteria:

  • Donor frozen embryo transfer

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ongoing pregnancy
Time Frame: 4 month
gestational week 12
4 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pregnancy rate
Time Frame: 4 month
positive hCG
4 month
Pregnancy loss
Time Frame: 4 month
pregnancy loss before week 7
4 month

Collaborators and Investigators

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

Sponsor

Thor Haahr

Investigators

  • Study Chair: Peter Humaidan, DMsc, Fertility Clinic Skive

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)

February 1, 2018

Primary Completion (ACTUAL)

February 1, 2019

Study Completion (ACTUAL)

September 1, 2019

Study Registration Dates

First Submitted

March 12, 2018

First Submitted That Met QC Criteria

March 18, 2018

First Posted (ACTUAL)

March 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 10, 2019

Last Update Submitted That Met QC Criteria

September 9, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Progesterone03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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