InfertilityPhase 2NCT01029470
To Describe the Effect of rhLH Supplementation in Women With Hyporesponse to rhFSH After Pituitary Downregulation
A Phase 2 study testing Luveris in people with Infertility, run by Peking University Third Hospital at 1 site in China.
Trial summary
Primary objective: To evaluate the efficacy in terms of oocyte retrieval number of rLH supplement in women with hyporesponse to rFSH after pituitary downregulation. Secondary objective: To further explore the efficacy of rLH supplement in women with hyporesponse to rFSH after pituitary downregulation To evaluate the… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Luveris
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Dec 2009to Mar 2011
- Phase
- Phase 2
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 20-40 years old women
- With menstrual cycles ranged 24-35 days, intraindividual variability±3 days
- Basal FSH <10 IU/L at cycle D2-D5
- 18 < BMI < 30
- Presence of two ovaries
- No ovarian stimulation over the past 3 months
- Signed inform consent form.
Who cannot join
- Polycystic ovarian syndrome
- rAFS stage Ⅲ-Ⅳ endometriosis
- Chromosomal abnormalities, endocrinological and/or autoimmune disorders.
- More than two previously unsuccessful IVF.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University third Hospital
Beijing, Beijing Municipality, 100191
Jie Qiao, MD, PHD, 86-10-82266699
Jie Qiao, MD, PHD
About this study
Official title: A Multicentre, Prospective, Open Study to Describe the Effects of rhLH Supplement in Women With Hyporesponse to rFSH After Pituitary Downregulation.
Primary objective:
To evaluate the efficacy in terms of oocyte retrieval number of rLH supplement in women with hyporesponse to rFSH after pituitary downregulation.
Secondary objective:
To further explore the efficacy of rLH supplement in women with hyporesponse to rFSH after pituitary downregulation To evaluate the safety of rLH supplementation in hyporesponse women
Read the detailed description
Primary endpoint:
Number of oocyte retrieved
Secondary endpoints:
- Oestrodial on hCG day (pg/ml)
- Number of embryos
- Implantation rate (%)
- Clinical pregnancy rate (%)
- Ongoing PR per IVF cycle (%)
- Abortion rate (%)
- Ampoules of rFSH
- FertiQoL score Safety endpoint: adverse events
- Conditions
- Infertility
- Being tested
- Luveris
- Keywords
- Luveris, hyporesponse, pituitary downregulation, IVF, Infertility women
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LuverisDrug
Also called Gonal-f, ovidrel
Luveris 75IU or 150IU depending on the patient conditions, subcutaneous injection, Qd, from Day 8 till hCG Day
| Study group | Role | What they receive |
|---|---|---|
| Luveris | Experimental | Those subjects who experience hyponresponse to FSH stimulation during mid-follicle phase after pituitary downregulation will receive Luveris 75IU or 150IU IH injection daily till HCG day. Receives: Drug: Luveris |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of oocyte retrieved
Measured: 2009Dec-2010Oct
Secondary outcomes (8)
1. Oestrodial on hCG day (pg/ml) Safety: adverse events
Measured: 2009 Dec-2010 Oct
2. Number of embryos
Measured: 2009 Dec-2010 Oct
3. Implantation rate (%)
Measured: 2009 Dec-2010 Oct
4. Clinical pregnancy rate (%)
Measured: 2009 Dec-2010 Oct
5. Ongoing PR per IVF cycle (%)
Measured: 2009 Dec-2010 Oct
6. Abortion rate (%)
Measured: 2009 Dec-2010 Oct
7. Ampoules of rFSH
Measured: 2009 Dec-2010 Oct
8. FertiQoL score Safety: adverse events
Measured: 2009 Dec-2010 Oct
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionOct 2010 (estimated)
- Study completionMar 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Chongqing Medical Center for Women and Children, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Reproductive & Genetic Hospital of CITIC-Xiangya
- Investigators
- Jie Qiao, MD, PhD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029470
- Sponsor's protocol ID
- EMR700642-606
- Status last verified
- Dec 2009
- First submitted
- 9 Dec 2009
- Last updated
- 10 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Prospective, Open Study to Describe the Effects of rhLH Supplement in Women With Hyporesponse to rFSH After Pituitary Downregulation.
- ClinicalTrials.gov ID
- NCT01029470
- Acronym / sponsor ID
- EMR700642-606
- Conditions
- Infertility
- Keywords
- Luveris, hyporesponse, pituitary downregulation, IVF, Infertility women
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Chongqing Medical Center for Women and Children, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Reproductive & Genetic Hospital of CITIC-Xiangya
- Study start
- Dec 2009
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 10 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.
Primary objective:
To evaluate the efficacy in terms of oocyte retrieval number of rLH supplement in women with hyporesponse to rFSH after pituitary downregulation.
Secondary objective:
To further explore the efficacy of rLH supplement in women with hyporesponse to rFSH after pituitary downregulation To evaluate the safety of rLH supplementation in hyporesponse women
Detailed description
Primary endpoint:
Number of oocyte retrieved
Secondary endpoints:
- Oestrodial on hCG day (pg/ml)
- Number of embryos
- Implantation rate (%)
- Clinical pregnancy rate (%)
- Ongoing PR per IVF cycle (%)
- Abortion rate (%)
- Ampoules of rFSH
- FertiQoL score Safety endpoint: adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Luveris | Experimental | Drug: LuverisThose subjects who experience hyponresponse to FSH stimulation during mid-follicle phase after pituitary downregulation will receive Luveris 75IU or 150IU IH injection daily till HCG day. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 20-40 years old women
- With menstrual cycles ranged 24-35 days, intraindividual variability±3 days
- Basal FSH <10 IU/L at cycle D2-D5
- 18 < BMI < 30
- Presence of two ovaries
Key exclusion criteria (4 listed)
- Polycystic ovarian syndrome
- rAFS stage Ⅲ-Ⅳ endometriosis
- Chromosomal abnormalities, endocrinological and/or autoimmune disorders.
- More than two previously unsuccessful IVF.
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 |
|---|---|---|
| LuverisAlso: Gonal-f, ovidrelLuveris 75IU or 150IU depending on the patient conditions, subcutaneous injection, Qd, from Day 8 till hCG Day | Drug | Luveris |
Primary outcome
Number of oocyte retrieved
Time frame: 2009Dec-2010Oct
8 secondary outcomes
1. Oestrodial on hCG day (pg/ml) Safety: adverse events
Time frame: 2009 Dec-2010 Oct
2. Number of embryos
Time frame: 2009 Dec-2010 Oct
3. Implantation rate (%)
Time frame: 2009 Dec-2010 Oct
4. Clinical pregnancy rate (%)
Time frame: 2009 Dec-2010 Oct
5. Ongoing PR per IVF cycle (%)
Time frame: 2009 Dec-2010 Oct
6. Abortion rate (%)
Time frame: 2009 Dec-2010 Oct
7. Ampoules of rFSH
Time frame: 2009 Dec-2010 Oct
8. FertiQoL score Safety: adverse events
Time frame: 2009 Dec-2010 Oct
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2009.
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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.
Jie Qiao, MD, PhD principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Luveris in people with Infertility, run by Peking University Third Hospital at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 10 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 China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Qiao, MD, PHD (86-10-82266699, qiaojiebu3h@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of oocyte retrieved (time frame: 2009Dec-2010Oct). 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 10 Dec 2009.