GnRH Agonist as Luteal Support in FET Cycles

Study Overview
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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

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

Conditions
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Infertility

Intervention / Treatment
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* Drug: Natural cycle: Triptorelin acetate 0.1 mg
* Drug: Hormone replacement cycle and triptorelin acetate 0.1 mg


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Natural cycle, control<br>Treatment cycles with normal luteal support with progesteron | |
| Experimental: Natural cycle, intervention<br>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<br>* 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<br>|
| No Intervention: Hormone replacement cycle, control<br>Standard hormone replacement cycle with estrogen and progesteron | |
| Experimental: Hormone replacement cycle, intervention<br>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<br>* 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<br>Drug: Hormone replacement cycle and triptorelin acetate 0.1 mg<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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