Ovarian StimulationPhase 3NCT01037699

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

A Phase 3 study testing rFSH: Follicle Stimulating Hormone and rFSH: Follicle Stimulating Hormone and rLH: Luteinizing Hormone (Recombinant Luteotrophin alfa) in people with Ovarian Stimulation, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 39 years, women onlyHealthy volunteers can take part
Conditions the study is for: Ovarian Stimulation
What is being tested?: rFSH: Follicle Stimulating Hormone and rFSH: Follicle Stimulating Hormone and rLH: Luteinizing Hormone (Recombinant Luteotrophin alfa)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 720 participants
Where: 1 siteSpain
Study dates: Jan 2005to Mar 2008
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 39 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

1st-2nd IVF cycle.
Age until 39 years old
BMI: 18-29.9.
Basal FSH < 12 IU/L

Who cannot join

LH:FSH > 2 (PCO)
Low response background (< 5 oocytes)
Endometrioma
Recurrent pregnancy loss
Any preimplantational genetic diagnosis indication
Any systemic, metabolic or endocrinological disorder.

Trial locations and contacts

1 site in 1 country.

Spain1 site

IVI Valencia
Valencia, Valencia, 46117

Other trials in Spain

About this study

Read the 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.

Conditions: Ovarian Stimulation
Being tested: rFSH: Follicle Stimulating Hormone, rFSH: Follicle Stimulating Hormone and rLH: Luteinizing Hormone (Recombinant Luteotrophin alfa)
Keywords: Ovarian stimulation, In Vitro Fertilization, Luteinizing Hormone, GnRH antagonist, Implantation rate in infertile patients undergoing In vitro fertilization and embryo transfer.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01037699
Study group	Role	What they receive
FSH YOUNGER	Active comparator	Not described Receives: Drug: rFSH: Follicle Stimulating Hormone
FSH OLDER	Active comparator	Not described Receives: Drug: rFSH: Follicle Stimulating Hormone
FSH LH YOUNGER (Recombinant Luteotrophin alfa)	Experimental	Not described Receives: Drug: rFSH: Follicle Stimulating Hormone and rLH: Luteinizing Hormone (Recombinant Luteotrophin alfa)
FSH LH OLDER	Experimental	Not described Receives: Drug: rFSH: Follicle Stimulating Hormone and rLH: Luteinizing Hormone (Recombinant Luteotrophin alfa)

What is being measured

The primary outcome is the main question the study is designed to answer.

Implantation rate
Measured: 4 weeks after embryo transfer

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2005Mar 2008

First posted23 Dec 2009 (estimated)
Study startJan 2005
Primary completionMar 2008
Study completionMar 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ovarian StimulationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 720 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01037699
Sponsor's protocol ID: 0502-C-M05-EB
Status last verified: Dec 2009
First submitted: 21 Dec 2009
Last updated: 23 Dec 2009
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingPhase 1/2
Opt-IVF for Personalized Medicine for Normal Responders
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Recruiting
Trigger Timing in Ovarian Stimulations
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RecruitingObservational study
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All Ovarian Stimulation trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Luteinizing Hormone (LH) Supplementation in Gonadotropin-releasing Hormone (GnRH) Antagonist Cycles
ClinicalTrials.gov ID: NCT01037699
Acronym / sponsor ID: 0502-C-M05-EB
Conditions: Ovarian Stimulation
Keywords: Ovarian stimulation, In Vitro Fertilization, Luteinizing Hormone, GnRH antagonist, Implantation rate in infertile patients undergoing In vitro fertilization and embryo transfer.
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 720 participants (actual)
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
Study start: Jan 2005
Primary completion: Mar 2008 (actual)
Study completion: Mar 2008 (actual)
First posted: 23 Dec 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

A maximum of 3 embryos were transferred on day 3 of embryo development.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
FSH YOUNGER	Active comparator	Drug: rFSH: Follicle Stimulating Hormone
FSH OLDER	Active comparator	Drug: rFSH: Follicle Stimulating Hormone
FSH LH YOUNGER (Recombinant Luteotrophin alfa)	Experimental	Drug: rFSH: Follicle Stimulating Hormone and rLH: Luteinizing Hormone (Recombinant Luteotrophin alfa)
FSH LH OLDER	Experimental	Drug: rFSH: Follicle Stimulating Hormone and rLH: Luteinizing Hormone (Recombinant Luteotrophin alfa)

Who may qualify

Ages: 18 to 39 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

1st-2nd IVF cycle.
Age until 39 years old
BMI: 18-29.9.
Basal FSH < 12 IU/L

Key exclusion criteria (6 listed)

LH:FSH > 2 (PCO)
Low response background (< 5 oocytes)
Endometrioma
Recurrent pregnancy loss
Any preimplantational genetic diagnosis indication

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
rFSH: Follicle Stimulating Hormone	Drug	FSH YOUNGER
rFSH: Follicle Stimulating Hormone	Drug	FSH OLDER
rFSH: Follicle Stimulating Hormone and rLH: Luteinizing Hormone (Recombinant Luteotrophin alfa)	Drug	FSH LH YOUNGER (Recombinant Luteotrophin alfa)
rFSH: Follicle Stimulating Hormone and rLH: Luteinizing Hormone (Recombinant Luteotrophin alfa)	Drug	FSH LH OLDER

Primary outcome

Implantation rate
Time frame: 4 weeks after embryo transfer

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2009.

Related trials for Ovarian Stimulation

Active, not recruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
RecruitingPhase 2
Autologous Hair Follicle-Derived Secretome and Platelet-Rich Plasma for Premature Ovarian Insufficiency
Premature Ovarian Insufficiency, POI
Active, not recruitingPhase 1/2
Opt-IVF for Personalized Medicine for Normal Responders
Ivf
Recruiting
Trigger Timing in Ovarian Stimulations
IVF Outcome
RecruitingObservational study
Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)
Infertility

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ernesto Bosch, MDPhD principal investigator

IVI Valencia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implantation rate (time frame: 4 weeks after embryo transfer). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01037699.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2009.