Frozen-thawed Embryo Transfer in a Naturally Stimulated Cycle: Does hCG Triggering Bring Any Advantage in Comparison to Testing LH Surge With Home Tests?

Study Overview
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Brief Summary
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The primary aim of this study is to find out if ovulation triggered with hCG provides any additional benefit in comparison to spontaneous LH surge measured with the home test when transferring frozen-thawed embryo in a naturally stimulated cycle.

Official Title
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A Protocol for a Randomized, Two-Parallel-group Study to Compare the Efficacy of Testing LH Surge at Home Versus Medically Triggered Ovulation With hCG (Pregnyl®) in the Naturally Stimulated Cycle in the Frozen-thawed Embryo Transfer

Conditions
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Infertility

Intervention / Treatment
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* Drug: Human chorionic gonadotropin
* Other: Home ovulation test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patient with IVF or ICSI cycle and therefore having frozen-thawed embryos Regular menstruation cycle Patient's willingness to participate in the study Exclusion Criteria: - Irregular menstrual cycle demanding preparing endometrium with hormones for frozen-thawed embryo No frozen embryos after IVF cycle Allergy to Pregnyl® or some of its ingredients in the medication or other contraindications due to Pregnyl®

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 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: Pregnyl (Human chorionic gonadotropin)<br>In this group, patients have natural cycle in frozen-thawed embryo transfer and the ovulation is confirmed by administration of hCG (Pregnyl® 5000 IU). The day of transferring embryo is depending on the day of administration of hCG and the age of the embryo. The day zero day is defined by ovulation triggered by hCG. | Drug: Human chorionic gonadotropin<br>* Human chorionic gonadotropin (Pregnyl, 5000IU) is used in the medication group to confirme the ovulation.<br>* Other names: Home ovulation test;|
| Other: Home ovulation test<br>The patients randomized to the LH surge group perform the ovulation home test daily from the urine. Thus, the ovulation in this group is corfimed by the urine test. The day of transferring embryo is depending on the positive ovulation test and the age of the embryo. The day zero day is defined by positive ovulation test. | Other: Home ovulation test<br>* The ovulation in the natural menstrual cycle is confirmed by the home ovulation tests from the urine.<br>|

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 |