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Completed

NCT Number: NCT01037699

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

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.

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Key information

Conditions

OVARIAN STIMULATION

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

IVI Valencia

Valencia, 46117, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rFSH: Follicle Stimulating Hormone

Drug

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

Drug

Primary outcomes

  1. Implantation rate

    Time frame: 4 weeks after embryo transfer

Sponsors and collaborators

Lead sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Other

Registry information

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Dec 23, 2009
Registry last updated
Dec 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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