Substituted Frozen Embryo Transfer Cycles With GnRH-agonist Supplementation

June 22, 2020 updated by: Peter Humaidan

The aim of this study is to compare two FET protocols by modifying the substituted FET cycle in order to maintain a higher ongoing positive pregnancy rate and thus reduce the early pregnancy loss.

Hypothesis: adding GnRH-agonist to the substituted cycle in FET treatment reduces the early pregnancy loss.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

287

Phase

  • Phase 4

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
      • Fredericia, Denmark, 7000
        • IVF syd
      • 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

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Endometrial thickness ≥ 7 mm after stimulation
  • 18-45 years
  • IVF/ICSI fertilisation
  • BMI > 18,5 <30 kg/m2
  • cycle length 25-34 days

Exclusion Criteria:

  • endometrial thickness < 7 mm or no triple layer endometrium and/or functional follicles
  • Uterine abnormality
  • Chronic medical disease
  • oocyte donation cycles

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
Experimental: Substituted FET cycle and GnRHa
Substituted FET GnRH-a 2 bolus two days before Estradiol 6 mg Progesterone (Crinone) 180 mg
Drug: Estradiol and progeterone
Estradiol and progesterone
Other Names:
  • Estradiol and progesterone
Active Comparator: Substituted FET cycle
substituted FET cycle Estradiol Progesterone
Drug: Estradiol and progeterone
Estradiol and progesterone
Other Names:
  • Estradiol and progesterone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pregnancy loss rate
Time Frame: Primary outcome is avaible after 12th week of gestational.
Primary outcome is avaible after 12th week of gestational.

Secondary Outcome Measures

Outcome Measure
Time Frame
Pregnancy rate
Time Frame: 14 days after embryo transfer.
14 days after embryo transfer.

Other Outcome Measures

Outcome Measure
Time Frame
Luteal progesterone levels
Time Frame: 7th week of gestation
7th week of gestation

Collaborators and Investigators

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

Sponsor

Peter Humaidan

Investigators

  • Principal Investigator: Birgit Alsbjerg, M.D., Fertility Clinic Regional Hospital 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

December 1, 2013

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

September 12, 2013

First Submitted That Met QC Criteria

September 16, 2013

First Posted (Estimate)

September 17, 2013

Study Record Updates

Last Update Posted (Actual)

June 23, 2020

Last Update Submitted That Met QC Criteria

June 22, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Skive-2013-BA

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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