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

I

Instituto Valenciano de Infertilidad, IVI VALENCIA

Status and phase

Completed
Phase 3

Conditions

Ovarian Stimulation

Treatments

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

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)

720 participants in 4 patient groups

FSH YOUNGER
Active Comparator group
Treatment:
Drug: rFSH: Follicle Stimulating Hormone
FSH OLDER
Active Comparator group
Treatment:
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)
FSH LH OLDER
Experimental group
Treatment:
Drug: rFSH: Follicle Stimulating Hormone and rLH: Luteinizing Hormone (Recombinant Luteotrophin alfa)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems