NCT01943812

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
287

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2013

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 17, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

June 23, 2020

Status Verified

June 1, 2020

Enrollment Period

5.3 years

First QC Date

September 12, 2013

Last Update Submit

June 22, 2020

Conditions

Pregnancy LossFrozen Embryo Transfer

Outcome Measures

Primary Outcomes (1)

  • Pregnancy loss rate

    Primary outcome is avaible after 12th week of gestational.

Secondary Outcomes (1)

  • Pregnancy rate

    14 days after embryo transfer.

Other Outcomes (1)

  • Luteal progesterone levels

    7th week of gestation

Study Arms (2)

Substituted FET cycle and GnRHa

EXPERIMENTAL

Substituted FET GnRH-a 2 bolus two days before Estradiol 6 mg Progesterone (Crinone) 180 mg

Drug: Estradiol and progeterone

Substituted FET cycle

ACTIVE COMPARATOR

substituted FET cycle Estradiol Progesterone

Drug: Estradiol and progeterone

Interventions

Estradiol and progeteroneDRUG

Estradiol and progesterone

Also known as: Estradiol and progesterone
Substituted FET cycleSubstituted FET cycle and GnRHa

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

IVF syd

Fredericia, 7000, Denmark

Location

Fertility Clinic Regional Hospital Skive

Skive, 7800, Denmark

Location

MeSH Terms

Interventions

EstradiolProgesterone

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPregnenedionesPregnenesPregnanesCorpus Luteum HormonesProgesterone Congeners

Study Officials

  • Birgit Alsbjerg, M.D.

    Fertility Clinic Regional Hospital Skive

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
D.M.Sc., M.D.

Study Record Dates

First Submitted

September 12, 2013

First Posted

September 17, 2013

Study Start

December 1, 2013

Primary Completion

April 1, 2019

Study Completion

April 1, 2020

Last Updated

June 23, 2020

Record last verified: 2020-06

Locations

DK(2)