Luteal Phase Support in Insemination Cycles

Study Overview
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Brief Summary
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This study is a prospective randomized trial with 242 IUI cycles. Patients are randomized in two groups including 121 cycles in each group. A total of 255 cycles in 167 patients are finally recruited. In the first group, the patients will be treated with triptorelin (Gonapeptyl®) in their luteal phase. As for the other group, the patients will undergo the luteal phase without any supportive medication. This study is going to clarify the role of the gonadotropin agonist (triptorelin acetate, Gonapeptyl®) as a luteal phase supporter. The benefit of the treatment is measured by the numbers in the live birth and clinical pregnancy rates.

Official Title
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A Protocol for a Randomized, Controlled Study to Compare the Use of Gonodotropin-releasing Hormone Agonist Triptoreline (Gonapeptyl®) for Luteal Phase Support Versus Natural Luteal Phase in the Insemination Cycles

Conditions
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Infertility, Female

Intervention / Treatment
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* Drug: Triptorelin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients with ovarian stimulation cycles preparing to insemination Patients with medical ovarian stimulation protocols including GnRH agonist, aromatase inhibitors and different combinations of GnRH agonists and aromatase inhibitors are included Patient's willingness to participate in the study Exclusion Criteria: - Failure in the ovarian stimulation cycle Failures in executing the insemination Failures in giving the sperm sample Major troubles in sperm parameters leading to an inadequate sample to accomplish intrauterine insemination Patients with primarily planned progesterone luteal support

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 43 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gonapeptyl<br>In the intervention group the patient will get the advice to using triptorelin (Gonapeptyl®) in the eight day after the injection of hCG (Pregnyl®) in the insemination cycle. | Drug: Triptorelin<br>* Triptorelin 0,1mg/ml subcutaneously once in a luteal phase in insemination cycles.<br>|
| No Intervention: Control group<br>In the control group, there are no luteal phase medications in the insemination cycle. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate |  | At possible delivery (about 40 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate |  | After two weeks | 
| Miscarriage rate |  | During subsequent about 40 weeks of pregnancy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Triptorelin, Insemination, Luteal phase support, Gonadotropin-releasing hormone agonist