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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01037699
Enrollment
720
Registered
2009-12-23
Start date
2005-01-31
Completion date
2008-03-31
Last updated
2009-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Stimulation

Keywords

Ovarian stimulation, In Vitro Fertilization, Luteinizing Hormone, GnRH antagonist, Implantation rate in infertile patients undergoing In vitro fertilization and embryo transfer.

Brief summary

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

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.

Interventions

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

Sponsors

Instituto Valenciano de Infertilidad, IVI VALENCIA
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Implantation rate4 weeks after embryo transfer

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026