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

This study has been completed.
Sponsor:
Information provided by:
Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT01037699
First received: December 21, 2009
Last updated: December 22, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Ovarian Stimulation
Drug: rFSH: Follicle Stimulating Hormone
Drug: rFSH: Follicle Stimulating Hormone and rLH: Luteinizing Hormone (Recombinant Luteotrophin alfa)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Instituto Valenciano de Infertilidad, Spain:

Primary Outcome Measures:
  • Implantation rate [ Time Frame: 4 weeks after embryo transfer ] [ Designated as safety issue: No ]

Enrollment: 720
Study Start Date: January 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: FSH YOUNGER Drug: rFSH: Follicle Stimulating Hormone
Active Comparator: FSH OLDER Drug: rFSH: Follicle Stimulating Hormone
Experimental: FSH LH YOUNGER (Recombinant Luteotrophin alfa) Drug: rFSH: Follicle Stimulating Hormone and rLH: Luteinizing Hormone (Recombinant Luteotrophin alfa)
Experimental: FSH LH OLDER Drug: rFSH: Follicle Stimulating Hormone and rLH: Luteinizing Hormone (Recombinant Luteotrophin alfa)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01037699

Locations
Spain
IVI Valencia
Valencia, Spain, 46117
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, Spain
Investigators
Principal Investigator: Ernesto Bosch, MDPhD IVI Valencia
  More Information

No publications provided

Responsible Party: Dr. Ernesto Bosch, IVI Valencia
ClinicalTrials.gov Identifier: NCT01037699     History of Changes
Other Study ID Numbers: 0502-C-M05-EB
Study First Received: December 21, 2009
Last Updated: December 22, 2009
Health Authority: Spain: Ministry of Health

Keywords provided by Instituto Valenciano de Infertilidad, Spain:
Ovarian stimulation
In Vitro Fertilization
Luteinizing Hormone
GnRH antagonist
Implantation rate in infertile patients undergoing In vitro fertilization and embryo transfer.

Additional relevant MeSH terms:
Hormones
Follicle Stimulating Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014