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

Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA (Other)

Overall Status

Completed

CT.gov ID

NCT01037699

Collaborator

(none)

720

Enrollment

Location

Arms

37.9

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

720 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Jan 1, 2005

Actual Primary Completion Date :

Mar 1, 2008

Actual Study Completion Date :

Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

Implantation rate [4 weeks after embryo transfer]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 39 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IVI Valencia	Valencia		Spain	46117

Sponsors and Collaborators

Instituto Valenciano de Infertilidad, IVI VALENCIA

Investigators

Principal Investigator: Ernesto Bosch, MDPhD, IVI Valencia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01037699

Other Study ID Numbers:

0502-C-M05-EB

First Posted:

Dec 23, 2009

Last Update Posted:

Dec 23, 2009

Last Verified:

Dec 1, 2009

Keywords provided by , ,

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

Study Results

No Results Posted as of Dec 23, 2009