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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01037699
Other study ID # 0502-C-M05-EB
Secondary ID
Status Completed
Phase Phase 3
First received December 21, 2009
Last updated December 22, 2009
Start date January 2005
Est. completion date March 2008

Study information

Verified date December 2009
Source Instituto Valenciano de Infertilidad, IVI VALENCIA
Contact n/a
Is FDA regulated No
Health authority Spain: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 720
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 39 Years
Eligibility 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.

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
rFSH: Follicle Stimulating Hormone

rFSH: Follicle Stimulating Hormone

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

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


Locations

Country Name City State
Spain IVI Valencia Valencia

Sponsors (1)

Lead Sponsor Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Implantation rate 4 weeks after embryo transfer No
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