To Describe the Effect of rhLH Supplementation in Women With Hyporesponse to rhFSH After Pituitary Downregulation
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Peking University Third Hospital.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Peking University Third Hospital
Collaborators:
Peking Union Medical College Hospital
Chongqing Health Center for Women and Children
The Affiliated DrumTower Hospital of Nanjing University Medical School
Reproductive & Genetic Hospital of CITIC-Xiangya
Information provided by:
Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT01029470
First received: December 9, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Infertility |
Drug: Luveris |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicentre, Prospective, Open Study to Describe the Effects of rhLH Supplement in Women With Hyporesponse to rFSH After Pituitary Downregulation. |
Resource links provided by NLM:
Further study details as provided by Peking University Third Hospital:
Primary Outcome Measures:
- Number of oocyte retrieved [ Time Frame: 2009Dec-2010Oct ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 1. Oestrodial on hCG day (pg/ml) Safety: adverse events [ Time Frame: 2009 Dec-2010 Oct ] [ Designated as safety issue: Yes ]
- 2. Number of embryos [ Time Frame: 2009 Dec-2010 Oct ] [ Designated as safety issue: Yes ]
- 3. Implantation rate (%) [ Time Frame: 2009 Dec-2010 Oct ] [ Designated as safety issue: Yes ]
- 4. Clinical pregnancy rate (%) [ Time Frame: 2009 Dec-2010 Oct ] [ Designated as safety issue: Yes ]
- 5. Ongoing PR per IVF cycle (%) [ Time Frame: 2009 Dec-2010 Oct ] [ Designated as safety issue: Yes ]
- 6. Abortion rate (%) [ Time Frame: 2009 Dec-2010 Oct ] [ Designated as safety issue: Yes ]
- 7. Ampoules of rFSH [ Time Frame: 2009 Dec-2010 Oct ] [ Designated as safety issue: Yes ]
- 8. FertiQoL score Safety: adverse events [ Time Frame: 2009 Dec-2010 Oct ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 150 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Luveris
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.
|
Drug: Luveris
Luveris 75IU or 150IU depending on the patient conditions, subcutaneous injection, Qd, from Day 8 till hCG Day
Other Name: Gonal-f, ovidrel
|
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
Eligibility| Ages Eligible for Study: | 20 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Polycystic ovarian syndrome
- rAFS stage Ⅲ-Ⅳ endometriosis
- Chromosomal abnormalities, endocrinological and/or autoimmune disorders.
- More than two previously unsuccessful IVF.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01029470
Contacts
| Contact: Jie Qiao, MD, PHD | 86-10-82266699 | qiaojiebu3h@163.com |
Locations
| China, Beijing | |
| Peking University third Hospital | Not yet recruiting |
| Beijing, Beijing, China, 100191 | |
| Contact: Jie Qiao, MD, PHD 86-10-82266699 | |
| Principal Investigator: Jie Qiao, MD, PHD | |
Sponsors and Collaborators
Peking University Third Hospital
Peking Union Medical College Hospital
Chongqing Health Center for Women and Children
The Affiliated DrumTower Hospital of Nanjing University Medical School
Reproductive & Genetic Hospital of CITIC-Xiangya
Investigators
| Principal Investigator: | Jie Qiao, MD, PhD | Peking University Third Hospital |
More Information
No publications provided
| Responsible Party: | Jie Qiao, Peking University Third Hospital Reproductive Medical Center |
| ClinicalTrials.gov Identifier: | NCT01029470 History of Changes |
| Other Study ID Numbers: | EMR700642-606 |
| Study First Received: | December 9, 2009 |
| Last Updated: | December 9, 2009 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Peking University Third Hospital:
|
Luveris hyporesponse pituitary downregulation IVF Infertility women |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 19, 2013