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
Sponsor:
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

December 9, 2009
December 9, 2009
December 2009
October 2010   (final data collection date for primary outcome measure)
Number of oocyte retrieved [ Time Frame: 2009Dec-2010Oct ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
To Describe the Effect of rhLH Supplementation in Women With Hyporesponse to rhFSH After Pituitary Downregulation
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

Primary endpoint:

Number of oocyte retrieved

Secondary endpoints:

  1. Oestrodial on hCG day (pg/ml)
  2. Number of embryos
  3. Implantation rate (%)
  4. Clinical pregnancy rate (%)
  5. Ongoing PR per IVF cycle (%)
  6. Abortion rate (%)
  7. Ampoules of rFSH
  8. FertiQoL score Safety endpoint: adverse events
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Infertility
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
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.
Intervention: Drug: Luveris
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
150
March 2011
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 20-40 years old women
  2. With menstrual cycles ranged 24-35 days, intraindividual variability±3 days
  3. Basal FSH <10 IU/L at cycle D2-D5
  4. 18 < BMI < 30
  5. Presence of two ovaries
  6. No ovarian stimulation over the past 3 months
  7. Signed inform consent form.

Exclusion Criteria:

  1. Polycystic ovarian syndrome
  2. rAFS stage Ⅲ-Ⅳ endometriosis
  3. Chromosomal abnormalities, endocrinological and/or autoimmune disorders.
  4. More than two previously unsuccessful IVF.
Female
20 Years to 40 Years
No
Contact: Jie Qiao, MD, PHD 86-10-82266699 qiaojiebu3h@163.com
China
 
NCT01029470
EMR700642-606
No
Jie Qiao, Peking University Third Hospital Reproductive Medical Center
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
Principal Investigator: Jie Qiao, MD, PhD Peking University Third Hospital
Peking University Third Hospital
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP