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

Instituto Valenciano de Infertilidad, IVI VALENCIA

Status and phase: Completed; Phase 3

Conditions: Ovarian Stimulation

Treatments: Drug: rFSH: Follicle Stimulating Hormone and rLH: Luteinizing Hormone (Recombinant Luteotrophin alfa); Drug: rFSH: Follicle Stimulating Hormone

Study type: Interventional

Funder types: Other

Identifiers

NCT01037699

0502-C-M05-EB

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 720 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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720 participants in 4 patient groups

FSH YOUNGER

Active Comparator group

Treatment:

Drug: rFSH: Follicle Stimulating Hormone

Drug: rFSH: Follicle Stimulating Hormone

FSH OLDER

Active Comparator group

Treatment:

Drug: rFSH: Follicle Stimulating Hormone

Drug: rFSH: Follicle Stimulating Hormone

FSH LH YOUNGER (Recombinant Luteotrophin alfa)

Experimental group

Treatment:

Drug: rFSH: Follicle Stimulating Hormone and rLH: Luteinizing Hormone (Recombinant Luteotrophin alfa)

Drug: rFSH: Follicle Stimulating Hormone and rLH: Luteinizing Hormone (Recombinant Luteotrophin alfa)

FSH LH OLDER

Experimental group

Treatment:

Drug: rFSH: Follicle Stimulating Hormone and rLH: Luteinizing Hormone (Recombinant Luteotrophin alfa)

Drug: rFSH: Follicle Stimulating Hormone and rLH: Luteinizing Hormone (Recombinant Luteotrophin alfa)