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
  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:

  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
  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 16, 2014