Luteinizing Hormone (LH) Supplementation in Gonadotropin-releasing Hormone (GnRH) Antagonist Cycles

Study Overview
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Brief Summary
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To analyse the impact on cycle outcome of LH supplementation in ovarian stimulation controlled with a GnRH antagonist in two ages groups: patients upto 35 years old, and patients aged between 36 and 39 years old.

Detailed Description
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All patients received an oral contraceptive pill with 0.030 mg of ethinyl-estradiol and 3.0 mg of drospirenone the cycle prior to ovarian stimulation. On the second day of menstruation, patients started ovarian stimulation as follows: Patients < 36: 225 IU/day of recombinant FSH (FSH alone group) or 150 IU of rFSH and 75 IU of rLH/day (FSH+LH group) for 5 days. On day 6, a 0.25 mg/day dose of the GnRH antagonist Cetrorelix is added until the day of rCG administration. Patients 36-39: Initial dose of 300 IU of rFSH /day (FSH alone group)) or 225 IU of rFSH and 75 IU of rLH/day (FSH + LH group) for 5 days. On day 6, a 0.25 mg/day dose of the GnRH antagonist Cetrorelix is added until the day of rCG administration. A maximum of 3 embryos were transferred on day 3 of embryo development.

Conditions
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Ovarian Stimulation

Intervention / Treatment
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* Drug: rFSH: Follicle Stimulating Hormone
* Drug: rFSH: Follicle Stimulating Hormone
* Drug: rFSH: Follicle Stimulating Hormone and rLH: Luteinizing Hormone (Recombinant Luteotrophin alfa)
* Drug: rFSH: Follicle Stimulating Hormone and rLH: Luteinizing Hormone (Recombinant Luteotrophin alfa)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1st-2nd IVF cycle. Age until 39 years old BMI: 18-29.9. Basal FSH < 12 IU/L Exclusion Criteria: LH:FSH > 2 (PCO) Low response background (< 5 oocytes) Endometrioma Recurrent pregnancy loss Any preimplantational genetic diagnosis indication Any systemic, metabolic or endocrinological disorder.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 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 |
| --- | --- |
| Active Comparator: FSH YOUNGER<br> | Drug: rFSH: Follicle Stimulating Hormone<br> <br> |
| Active Comparator: FSH OLDER<br> | Drug: rFSH: Follicle Stimulating Hormone<br> <br> |
| Experimental: FSH LH YOUNGER (Recombinant Luteotrophin alfa)<br> | Drug: rFSH: Follicle Stimulating Hormone and rLH: Luteinizing Hormone (Recombinant Luteotrophin alfa)<br> <br> |
| Experimental: FSH LH OLDER<br> | Drug: rFSH: Follicle Stimulating Hormone and rLH: Luteinizing Hormone (Recombinant Luteotrophin alfa)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate |  | 4 weeks after embryo transfer | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian stimulation, In Vitro Fertilization, Luteinizing Hormone, GnRH antagonist, Implantation rate in infertile patients undergoing In vitro fertilization and embryo transfer.