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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01037699
First Posted: December 23, 2009
Last Update Posted: December 23, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Instituto Valenciano de Infertilidad, IVI VALENCIA
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Implantation rate [ Time Frame: 4 weeks after embryo transfer ]

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

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01037699


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

Responsible Party: Dr. Ernesto Bosch, IVI Valencia
ClinicalTrials.gov Identifier: NCT01037699     History of Changes
Other Study ID Numbers: 0502-C-M05-EB
First Submitted: December 21, 2009
First Posted: December 23, 2009
Last Update Posted: December 23, 2009
Last Verified: December 2009

Keywords provided by Instituto Valenciano de Infertilidad, IVI VALENCIA:
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