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

NCT ID: NCT01037699

Last Updated: 2009-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

720 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2008-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ovarian Stimulation

Keywords

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Ovarian stimulation In Vitro Fertilization Luteinizing Hormone GnRH antagonist Implantation rate in infertile patients undergoing In vitro fertilization and embryo transfer.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FSH YOUNGER

Group Type ACTIVE_COMPARATOR

rFSH: Follicle Stimulating Hormone

Intervention Type DRUG

FSH OLDER

Group Type ACTIVE_COMPARATOR

rFSH: Follicle Stimulating Hormone

Intervention Type DRUG

FSH LH YOUNGER (Recombinant Luteotrophin alfa)

Group Type EXPERIMENTAL

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

Intervention Type DRUG

FSH LH OLDER

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Interventions

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rFSH: Follicle Stimulating Hormone

Intervention Type DRUG

rFSH: Follicle Stimulating Hormone

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role lead

Responsible Party

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IVI Valencia

Principal Investigators

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Ernesto Bosch, MDPhD

Role: PRINCIPAL_INVESTIGATOR

IVI Valencia

Locations

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IVI Valencia

Valencia, Valencia, Spain

Site Status

Countries

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Spain

Other Identifiers

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0502-C-M05-EB

Identifier Type: -

Identifier Source: org_study_id