Study to Examine Effect of Recombinant Luteinizing Hormone (r-Lh) and Recombinant Human Chorionic Gonadotropin (r-hCG) for Ovarian Stimulation in Assisted Reproduction Techniques (ART)

Study Overview
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Brief Summary
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The study is a prospective, randomised, controlled, and non-blinded multi-center pilot study to evaluate endocrine efficacy of recombinant luteinizing hormone versus recombinant human chorionic gonadotropin administered during controlled ovarian stimulation for IVF/ICSI in normogonadotrophic women.

Official Title
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The Endocrine Efficacy of Either Recombinant Luteinizing Hormone (r-LH) or Low Dose Recombinant Human Chorionic Gonadotropin (r-hCG) Supplementation for Recombinant Follicle Stimulating Hormone (r-FSH) Stimulation in Normogonadotrophic Women Undergoing in Vitro Fertilization (IVF)/Intracytoplasmic Sperm Injection (ICSI) Therapy Following a Long-term Gonadotropin Releasing Hormone (GnRH) Agonist Down Regulation Protocol

Conditions
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Controlled Ovarian Stimulation, Infertility

Intervention / Treatment
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* Drug: recombinant luteinizing hormone (r-LH)
* Drug: recombinant human chorionic gonadotropin (r-hCG)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who plan to undergo IVF or ICSI treatment Woman's age > 18 years but ≤ 35 years Regular menstrual cycle (25-34 days) BMI 18 to 30 inclusive Signed patient information and informed consent forms Exclusion Criteria: PCOS More than 2 prior IVF/ICSI attempts Diabetes mellitus, epilepsy, lever-, kidney-, heart- and metabolism disorders, according to the Investigator's assessment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: recombinant luteinizing hormone<br>150 IU r-LH, recombinant luteinising hormone, from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14) | Drug: recombinant luteinizing hormone (r-LH)<br>* administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)<br>|
| Active Comparator: recombinant human chorionic gonadotrofin<br>25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 ) | Drug: recombinant human chorionic gonadotropin (r-hCG)<br>* administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Oestradiol Concentration on the Day of Ovulation Induction |  | treatment day 10 to 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COS, ART, Infertility