Outcome During r-hFSH StimulationNCT01223079
Use of r-hLH (Luveris) in Donors Previously Treated With r-hFSH (Gonal F)
A study testing r-hFSH and r-hFSH and r-hLH in people with Outcome During r-hFSH Stimulation and Outcome During r-hFSH and r-hLH Stimulation, run by Reproductive Medicine Associates of New Jersey at 1 site in United States.
Trial summary
The purpose of the study is to compare the safety and efficacy of r-hLH to r-hFSH in the late follicular phase of young women undergoing controlled ovarian stimulation for oocyte donation. Read more about this study
- Who is it for?
- Ages 21 to 32 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Outcome During r-hFSH Stimulation, Outcome During r-hFSH and r-hLH Stimulation
- What is being tested?
- r-hFSH and r-hFSH and r-hLH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Dec 2008
- Phase
- Interventional
- 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 21 to 32 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age less than or equal to 32 years old
- BMI<35
- Eligible for controlled ovarian simulation
- No PCO-type ovaries (PCO by USS image, >2.1 LH;FSH ratio on cycle day 3, insulin resistance, increase of testosterone over free testosterone)
- Meet all requirements for becoming an egg donor
- Willingness and ability to participate and comply with study protocol for the duration of the study
- Baseline FSH<11
Who cannot join
- Clinically significant systemic disease
- Any contraindication to gonadotropin therapy
- LH:FSH ratio greater than 3
- Pregnancy in the past 3 months
- Any medical condition which, in the judgment of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug
- Simultaneous participation in another clinical trial
Show all 9Show fewer
- Known active substance abuse, including tobacco and alcohol (>10 cigarettes/day)
- Refusal or inability to comply with protocol
- Known poor ovarian response
Trial locations and contacts
1 site in 1 country.
United States1 site
Reproductive Medicine Assoicates of New Jersey
Morristown, New Jersey, 07960
About this study
Official title: Use of r-hLH (Luveris) Late Follicular Phase for Controlled Ovarian Stimulation (COS) in Donor Patients Previously Treated With r-hFSH (Gonal F)in a Long Luteal Downregulated Cycle With GnRH Agonist. A Cross-over Study
The purpose of the study is to compare the safety and efficacy of r-hLH to r-hFSH in the late follicular phase of young women undergoing controlled ovarian stimulation for oocyte donation.
Read the detailed description
While the role of FSH is considered the fundamental driver of folliculogenesis, the role of LH in this process is more controversial. FSH is associated with stimulating growth and recruitment of follicles while LH is associated with the selection of dominant follicles destined for ovulation. We will use an open, prospective, cross-over study to compare the safety and efficacy of two different treatment protocols for controlled ovarian stimulation in egg donors.
20 participants will undergo two cycles of stimulation. The first one will be with r-hFSH though the cycle and the second with r-hFSH then r-hLH. The participants will have 1 month rest cycle between the treatment cycles. r-hFSH doses will be adjusted according to patient response. r-hLH dosing will begin when there are 2 follicles greater than or equal to 14mm in diameter. The does will be 300IU/day and continue until the day of r-hCG administration.
- Being tested
- r-hFSH, r-hFSH and r-hLH
- Keywords
- r-hFSH, r-hLH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
r-hFSHDrug
Also called Gonal F
r-hFSH dose to be determined by the patient's primary doctor and adjusted according to their response
r-hFSH and r-hLHDrug
Also called r-hFSH, Gonal F, r-hLH, Luveris
Patients will begin r-hLH at 300IU/day when there are 2 follicles greater than or equal to 14mm.
| Study group | Role | What they receive |
|---|---|---|
| r-hFSH (Gonal F) | Other | Patients will be treated with r-hFSH throughout the stimulation phase of their first cycle until r-hCG administration. Receives: Drug: r-hFSH |
| r-hFSH (Gonal F) and r-hLH (Luveris) | Other | Patients will be treated with r-hFSH only until they have 2 follicles greater than or equal to 14mm. Patients will then bring 300IU/day of r-hLH until r-hCG administration. Receives: Drug: r-hFSH and r-hLH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy of r-hFSH protocol
Evaluation of the safety and efficacy of r-hFSH for controlled ovarian stimulation in the same patients.
Measured: 6 months
Safety and efficacy of r-hFSH + r-hLH protocol
Evaluation of the safety and efficacy of r-hFSH for controlled ovarian stimulation in the same patients.
Measured: 6 months
Secondary outcomes (4)
Number of oocytes retrieved
Evaluation of the number of oocytes obtained as a function of stimulation protocol.
Measured: 6 months
Quality of embryos obtained
Evaluation of pregnancy rates (clinical and ongoing), delivery rates, multiple pregnancy rates and the number of cancelled cycles.
Measured: 6 months
Incidences of ovarian hyperstimulation syndrome
Evaluation of the potential adverse effects associated with ovarian stimulation
Measured: 6 months
Quality of oocytes obtained
Evaluation of the quality of oocytes obtained as a function of stimulation protocol.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startDec 2005
- Primary completionDec 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Outcome During r-hFSH 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive Medicine Associates of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard T Scott, MD, Principal investigator, Reproductive Medicine Associates of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223079
- Sponsor's protocol ID
- 20052361
- Status last verified
- Mar 2013
- First submitted
- 8 Oct 2010
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of r-hLH (Luveris) Late Follicular Phase for Controlled Ovarian Stimulation (COS) in Donor Patients Previously Treated With r-hFSH (Gonal F)in a Long Luteal Downregulated Cycle With GnRH Agonist. A Cross-over Study
- ClinicalTrials.gov ID
- NCT01223079
- Acronym / sponsor ID
- 20052361
- Keywords
- r-hFSH, r-hLH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 18 Oct 2010 (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.
The purpose of the study is to compare the safety and efficacy of r-hLH to r-hFSH in the late follicular phase of young women undergoing controlled ovarian stimulation for oocyte donation.
Detailed description
While the role of FSH is considered the fundamental driver of folliculogenesis, the role of LH in this process is more controversial. FSH is associated with stimulating growth and recruitment of follicles while LH is associated with the selection of dominant follicles destined for ovulation. We will use an open, prospective, cross-over study to compare the safety and efficacy of two different treatment protocols for controlled ovarian stimulation in egg donors.
20 participants will undergo two cycles of stimulation. The first one will be with r-hFSH though the cycle and the second with r-hFSH then r-hLH. The participants will have 1 month rest cycle between the treatment cycles. r-hFSH doses will be adjusted according to patient response. r-hLH dosing will begin when there are 2 follicles greater than or equal to 14mm in diameter. The does will be 300IU/day and continue until the day of r-hCG administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| r-hFSH (Gonal F) | Other | Drug: r-hFSHPatients will be treated with r-hFSH throughout the stimulation phase of their first cycle until r-hCG administration. |
| r-hFSH (Gonal F) and r-hLH (Luveris) | Other | Drug: r-hFSH and r-hLHPatients will be treated with r-hFSH only until they have 2 follicles greater than or equal to 14mm. Patients will then bring 300IU/day of r-hLH until r-hCG administration. |
Who may qualify
- Ages
- 21 to 32 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age less than or equal to 32 years old
- BMI<35
- Eligible for controlled ovarian simulation
- No PCO-type ovaries (PCO by USS image, >2.1 LH;FSH ratio on cycle day 3, insulin resistance, increase of testosterone over free testosterone)
- Meet all requirements for becoming an egg donor
Key exclusion criteria (9 listed)
- Clinically significant systemic disease
- Any contraindication to gonadotropin therapy
- LH:FSH ratio greater than 3
- Pregnancy in the past 3 months
- Any medical condition which, in the judgment of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug
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 |
|---|---|---|
| r-hFSHAlso: Gonal Fr-hFSH dose to be determined by the patient's primary doctor and adjusted according to their response | Drug | r-hFSH (Gonal F) |
| r-hFSH and r-hLHAlso: r-hFSH, Gonal F, r-hLH, LuverisPatients will begin r-hLH at 300IU/day when there are 2 follicles greater than or equal to 14mm. | Drug | r-hFSH (Gonal F) and r-hLH (Luveris) |
Primary outcome
Safety and efficacy of r-hFSH protocol
Time frame: 6 months
Evaluation of the safety and efficacy of r-hFSH for controlled ovarian stimulation in the same patients.
Safety and efficacy of r-hFSH + r-hLH protocol
Time frame: 6 months
Evaluation of the safety and efficacy of r-hFSH for controlled ovarian stimulation in the same patients.
4 secondary outcomes
Number of oocytes retrieved
Time frame: 6 months
Quality of embryos obtained
Time frame: 6 months
Incidences of ovarian hyperstimulation syndrome
Time frame: 6 months
Quality of oocytes obtained
Time frame: 6 months
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 5 Mar 2013.
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.
Richard T Scott, MD principal investigator
Reproductive Medicine Associates of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing r-hFSH and r-hFSH and r-hLH in people with Outcome During r-hFSH Stimulation and Outcome During r-hFSH and r-hLH Stimulation, run by Reproductive Medicine Associates of New Jersey at 1 site in United States.
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 7 inclusion and 9 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 5 Mar 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 United States. 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.
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?
Safety and efficacy of r-hFSH protocol (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2013.