Combination of Gonadotropin-releasing Hormone Agonist and Human Chorionic Gonadotropin Triggered by Normal Responder in GnRH-antagonist Cycles

Study Overview
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Brief Summary
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Background The trigger for the final maturation of the ovum by providing integration of Human Chorionic Gonadotropin (hCG) and Gonadotropin - releasing hormone (GnRH) agonist was first introduced long ago, but clinically not accepted until the advent of GnRH antagonist protocol in IVF treatment. In a recently published work which compared two types of ovulation induction (standard dose of hcg and in combination of GnRH agonist) in women with normal ovarian response, there was a statistically significant increase in the rates of implantation, clinical pregnancies and live births rates by providing integration of hCG and GnRH agonist. To conclude, providing GnRH agonist in combination of hCF in standard dose is today an accepted treatment for final maturation of the ovums. OBJECTIVE The investigators objective is to investigate whether providing integrated treatment of Gonadotropin - releasing hormone (GnRH) Agonist and human Chorionic Gonadotropin (hCG) to final maturation of the ovum can improve the quality of the embryos, clinical pregnancies and live births rates in women treated with GnRH Antagonist protocol. The main objective is to compare between two existing treatments.

Detailed Description
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Background The trigger for the final maturation of the ovum by providing integration of Human Chorionic Gonadotropin (hCG) and Gonadotropin - releasing hormone (GnRH) agonist was first introduced long ago, but clinically not accepted until the advent of GnRH antagonist protocol in IVF treatment. In order to prevent Ovarian Hyperstimulation Syndrome in the treatment cycles with GnRH antagonist protocol, it is possible to make the final maturation of the ovums by providing GnRH agonist. In a recently published work which compared two types of ovulation induction (standard dose of hcg and in combination of GnRH agonist) in women with normal ovarian response, there was a statistically significant increase in the rates of implantation, clinical pregnancies and live births rates by providing integration of hCG and GnRH agonist. To conclude, providing GnRH agonist in combination of hCF in standard dose is today an accepted treatment for final maturation of the ovums. OBJECTIVE The investigators objective is to investigate whether providing integrated treatment of Gonadotropin - releasing hormone (GnRH) Agonist and human Chorionic Gonadotropin (hCG) to final maturation of the ovum can improve the quality of the embryos, clinical pregnancies and live births rates in women treated with GnRH Antagonist protocol. The main objective is to compare between two existing treatments. PATIENTS & METHODS Women treated through IVF by protocol Gnarl - Antagonist

Official Title
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Combination of Gonadotropin-releasing Hormone Agonist and Human Chorionic Gonadotropin Triggered by Normal Responder in GnRH-antagonist Cycles

Conditions
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In-vitro Fertilization

Intervention / Treatment
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* Drug: hCG (Ovitrelle 250 mcg mcg - Merck Serono)
* Drug: hCG (Ovitrelle 250 mcg mcg - Merck Serono) + GnRH agonist (Decapeptyl 0.2mg - Ferring Gmgh)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who are going through IVF by protocol GnRH - Antagonist Exclusion Criteria: Women with Ovarian Hyperstimulation Syndrome

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: hCG<br>Injection of hCG - Human Chorionic Gonadotropin (Ovitrelle 250 mcg mcg - Merck Serono) | Drug: hCG (Ovitrelle 250 mcg mcg - Merck Serono)<br> <br> |
| Experimental: hCG + GnRH agonist<br>Injection of hCG - Human Chorionic Gonadotropin (Ovitrelle 250 mcg mcg - Merck Serono) and GnRH agonist - Gonadotropin - releasing hormone (Decapeptyl 0.2mg - Ferring Gmgh) | Drug: hCG (Ovitrelle 250 mcg mcg - Merck Serono) + GnRH agonist (Decapeptyl 0.2mg - Ferring Gmgh)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancies rate | Number of pregnancies per treatment Injection of hCG - Human Chorionic Gonadotropin (Ovitrelle 250 mcg mcg - Merck Serono) and GnRH agonist - Gonadotropin - releasing hormone (Decapeptyl 0.2mg - Ferring Gmgh) in comperesment to Human Chorionic Gonadotropin (Ovitrelle 250 mcg mcg - Merck Serono) | 1 month |