GnRH Agonist as Luteal Support in FET Cycles

NCT ID: NCT02620124

Last Updated: 2016-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Natural cycle, control

Treatment cycles with normal luteal support with progesteron

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Natural cycle: Triptorelin acetate 0.1 mg

Intervention Type DRUG

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

Hormone replacement cycle, control

Standard hormone replacement cycle with estrogen and progesteron

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Natural cycle: Triptorelin acetate 0.1 mg

Intervention Type DRUG

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

Hormone replacement cycle and triptorelin acetate 0.1 mg

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Varpu Jokimaa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital District of the South-West Finland

Other Identifiers

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T5/2013

Identifier Type: -

Identifier Source: org_study_id