Controlled Ovarian StimulationPhase 4NCT01339299

Study to Examine Effect of Recombinant Luteinizing Hormone (r-Lh) and Recombinant Human Chorionic Gonadotropin (r-hCG) for Ovarian Stimulation in Assisted Reproduction Techniques (ART)

A Phase 4 study testing recombinant luteinizing hormone (r-LH) and recombinant human chorionic gonadotropin (r-hCG) in people with Controlled Ovarian Stimulation and Infertility, run by Regionshospitalet Viborg, Skive at 1 site in Denmark.

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

The study is a prospective, randomised, controlled, and non-blinded multi-center pilot study to evaluate endocrine efficacy of recombinant luteinizing hormone versus recombinant human chorionic gonadotropin administered during controlled ovarian stimulation for IVF/ICSI in normogonadotrophic women. Read more about this study

Who is it for?: Ages 18 to 35 years, women only
Conditions the study is for: Controlled Ovarian Stimulation, Infertility
What is being tested?: recombinant luteinizing hormone (r-LH) and recombinant human chorionic gonadotropin (r-hCG)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteDenmark
Study dates: Oct 2009to Jul 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 35 years
Women only
No healthy volunteers
Adult

Who may be able to join

Women who plan to undergo IVF or ICSI treatment
Woman's age > 18 years but ≤ 35 years
Regular menstrual cycle (25-34 days)
BMI 18 to 30 inclusive
Signed patient information and informed consent forms

Who cannot join

PCOS
More than 2 prior IVF/ICSI attempts
Diabetes mellitus, epilepsy, lever-, kidney-, heart- and metabolism disorders, according to the Investigator's assessment.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Fertility Clinic Skive regional Hospital
Skive

Other trials in Denmark

About this study

Official title: The Endocrine Efficacy of Either Recombinant Luteinizing Hormone (r-LH) or Low Dose Recombinant Human Chorionic Gonadotropin (r-hCG) Supplementation for Recombinant Follicle Stimulating Hormone (r-FSH) Stimulation in Normogonadotrophic Women Undergoing in Vitro Fertilization (IVF)/Intracytoplasmic Sperm Injection (ICSI) Therapy Following a Long-term Gonadotropin Releasing Hormone (GnRH) Agonist Down Regulation Protocol

Conditions: Controlled Ovarian Stimulation, Infertility
Being tested: recombinant luteinizing hormone (r-LH), recombinant human chorionic gonadotropin (r-hCG)
Keywords: COS, ART, Infertility
Medical subject headings: Infertility

What participants receive

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

recombinant luteinizing hormone (r-LH)Drug
administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)
recombinant human chorionic gonadotropin (r-hCG)Drug
administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)

Study groups in NCT01339299
Study group	Role	What they receive
recombinant luteinizing hormone	Experimental	150 IU r-LH, recombinant luteinising hormone, from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14) Receives: Drug: recombinant luteinizing hormone (r-LH)
recombinant human chorionic gonadotrofin	Active comparator	25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 ) Receives: Drug: recombinant human chorionic gonadotropin (r-hCG)

What is being measured

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

The Oestradiol Concentration on the Day of Ovulation Induction
Measured: treatment day 10 to 14

Timeline

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

Oct 2009Jul 2012

First posted20 Apr 2011 (estimated)
Study startOct 2009
Primary completionJul 2012
Study completionJul 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Controlled 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 4
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01339299
Sponsor's protocol ID: 700642-603
Other IDs: 2009-009375-35, 2009
Status last verified: Apr 2011
First submitted: 19 Apr 2011
Last updated: 27 Nov 2013
Results posted: Yes, on ClinicalTrials.gov
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

Active, not recruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
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RecruitingObservational study
Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)
Infertility
Recruiting
225 IU Versus 300 IU Starting FSH Dose in PPOS for Good-Prognosis Women
Infertility (IVF Patients), Infertility Assisted Reproductive Technology
RecruitingPhase 4
Intranasal Nafarelin For Triggering Oocyte Maturation
Fertility Preservation
Not yet recruiting
Intra-ovarian CAPA-IVM vs Standard IVM
Infertility (IVF Patients), Infertility

All Controlled Ovarian Stimulation trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Endocrine Efficacy of Either Recombinant Luteinizing Hormone (r-LH) or Low Dose Recombinant Human Chorionic Gonadotropin (r-hCG) Supplementation for Recombinant Follicle Stimulating Hormone (r-FSH) Stimulation in Normogonadotrophic Women Undergoing in Vitro Fertilization (IVF)/Intracytoplasmic Sperm Injection (ICSI) Therapy Following a Long-term Gonadotropin Releasing Hormone (GnRH) Agonist Down Regulation Protocol
ClinicalTrials.gov ID: NCT01339299
Acronym / sponsor ID: 700642-603
Conditions: Controlled Ovarian Stimulation, Infertility
Keywords: COS, ART, Infertility
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Regionshospitalet Viborg, SkiveUniversity, hospital or other
Study start: Oct 2009
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 20 Apr 2011 (estimated)
Results: Posted 27 Nov 2013

Clinical summary

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
recombinant luteinizing hormone	Experimental	Drug: recombinant luteinizing hormone (r-LH)150 IU r-LH, recombinant luteinising hormone, from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14)
recombinant human chorionic gonadotrofin	Active comparator	Drug: recombinant human chorionic gonadotropin (r-hCG)25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )

Who may qualify

Ages: 18 to 35 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Women who plan to undergo IVF or ICSI treatment
Woman's age > 18 years but ≤ 35 years
Regular menstrual cycle (25-34 days)
BMI 18 to 30 inclusive
Signed patient information and informed consent forms

Key exclusion criteria (3 listed)

PCOS
More than 2 prior IVF/ICSI attempts
Diabetes mellitus, epilepsy, lever-, kidney-, heart- and metabolism disorders, according to the Investigator's assessment.

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
recombinant luteinizing hormone (r-LH)administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)	Drug	recombinant luteinizing hormone
recombinant human chorionic gonadotropin (r-hCG)administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)	Drug	recombinant human chorionic gonadotrofin

Primary outcome

The Oestradiol Concentration on the Day of Ovulation Induction
Time frame: treatment day 10 to 14

Results and safety

Results posted to the registry on 27 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Recombinant Human Chorionic Gonadotrofin	50	50
Recombinant Luteinizing Hormone	50	50

Primary outcome: The Oestradiol Concentration on the Day of Ovulation Induction

Time frame: treatment day 10 to 14. Mean (Standard Deviation). Unit: pmol/L

Measure	Recombinant Human Chorionic Gonadotrofin n = 50	Recombinant Luteinizing Hormone n = 50
Value	11482 (8210)	12262 (8100)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Recombinant Human Chorionic Gonadotrofin	0 of 50 (0%)	0 of 50 (0%)	Not reported
Recombinant Luteinizing Hormone	0 of 50 (0%)	0 of 50 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Controlled Ovarian Stimulation

Active, not recruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
RecruitingObservational study
Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)
Infertility
Recruiting
225 IU Versus 300 IU Starting FSH Dose in PPOS for Good-Prognosis Women
Infertility (IVF Patients), Infertility Assisted Reproductive Technology
RecruitingPhase 4
Intranasal Nafarelin For Triggering Oocyte Maturation
Fertility Preservation
Not yet recruiting
Intra-ovarian CAPA-IVM vs Standard IVM
Infertility (IVF Patients), 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.

The record lists no contact. Use the official record to reach the sponsor.

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 5 inclusion and 3 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 27 Nov 2013. 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 Denmark. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Oestradiol Concentration on the Day of Ovulation Induction (time frame: treatment day 10 to 14). 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 NCT01339299.

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 27 Nov 2013.