GnRH Agonist as Luteal Support in FET Cycles

November 22, 2016 updated by: Turku University Hospital

GnRH Anonist as Luteal Support in Frozen-thawed Embryo Transfer Cycles

Back ground: A single dose of GnRH analogue in the luteal phase is reported to improve the outcome of IVF/ICSI treatments but the effect in FET cycles has not been reported.

Aim: To compare the results of frozen thawed embryo transfers with and without GnRHa analogue support Primary end point: IR, PR, on going PR Secondary end point: hCH, E2 and progesterone levels 14 days after thawing

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

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

20 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 20 - 45 year old women comig to frozen thawed embryo transfer

Exclusion Criteria:

  • The age of the woman over 42 years during the initial ICF/ICSI- treatment from which the embryos derive
  • Abnormal uterus
  • Known abnormality of karyotype of the woman or her partner
  • Severe male factor as an exclusive reason for subfertility
  • Allegy for triptorelin acetate

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: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Natural cycle, control
Treatment cycles with normal luteal support with progesteron
EXPERIMENTAL: Natural cycle, intervention
Treatment cycles with normal luteal support with progesteron and a single dose of 0.1 mg triptorelin when the age of the embryo was 6 days: Intervention is the additional 0.1 mg triptorelin as described in the previous sentence.
Drug: Natural cycle: Triptorelin acetate 0.1 mg
A single dose of triptorelin acetate 0.1 s.c. was giwen when the age of the transferred embryo was six days in additon to standard micronized progesterone 400 mg vaginally
NO_INTERVENTION: Hormone replacement cycle, control
Standard hormone replacement cycle with estrogen and progesteron
EXPERIMENTAL: Hormone replacement cycle, intervention
Standard hormone replacement cycle with estrogen and progesteron and a single dose of 0.1 mg triptorelin when the age of the embryo was 6 days
Drug: Natural cycle: Triptorelin acetate 0.1 mg
A single dose of triptorelin acetate 0.1 s.c. was giwen when the age of the transferred embryo was six days in additon to standard micronized progesterone 400 mg vaginally
Drug: Hormone replacement cycle and triptorelin acetate 0.1 mg
A single dose of triptorelin acetate 0.1 s.c. was giwen when the age of the transferred embryo was six days in addition to standard Estradiol and progesterone support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pregnancy rate
Time Frame: five weeks after the embryo transfer
five weeks after the embryo transfer
Implantation rate
Time Frame: five weeks after the embryo transfer
five weeks after the embryo transfer
Ongoing pregnancy rate
Time Frame: ten weeks after the embryo transfer
ten weeks after the embryo transfer

Secondary Outcome Measures

Outcome Measure
Time Frame
hCG- level
Time Frame: 14 days after thawing of the embryos
14 days after thawing of the embryos

Collaborators and Investigators

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

Sponsor

Turku University Hospital

Investigators

  • Principal Investigator: Varpu Jokimaa, MD, PhD, Hospital District of the South-West Finland

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

May 1, 2013

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

October 1, 2015

Study Registration Dates

First Submitted

November 30, 2015

First Submitted That Met QC Criteria

November 30, 2015

First Posted (ESTIMATE)

December 2, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

November 23, 2016

Last Update Submitted That Met QC Criteria

November 22, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T5/2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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