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To Describe the Effect of rhLH Supplementation in Women With Hyporesponse to rhFSH After Pituitary Downregulation

Primary Purpose

Infertility

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Luveris
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Luveris, hyporesponse, pituitary downregulation, IVF, Infertility women

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University third Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Luveris

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of oocyte retrieved

Secondary Outcome Measures

1. Oestrodial on hCG day (pg/ml) Safety: adverse events
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: adverse events

Full Information

First Posted
December 9, 2009
Last Updated
December 9, 2009
Sponsor
Peking University Third Hospital
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
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1. Study Identification

Unique Protocol Identification Number
NCT01029470
Brief Title
To Describe the Effect of rhLH Supplementation in Women With Hyporesponse to rhFSH After Pituitary Downregulation
Official Title
A Multicentre, Prospective, Open Study to Describe the Effects of rhLH Supplement in Women With Hyporesponse to rFSH After Pituitary Downregulation.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
October 2010 (Anticipated)
Study Completion Date
March 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Peking University Third Hospital
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Luveris, hyporesponse, pituitary downregulation, IVF, Infertility women

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Luveris
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Luveris
Other Intervention Name(s)
Gonal-f, ovidrel
Intervention Description
Luveris 75IU or 150IU depending on the patient conditions, subcutaneous injection, Qd, from Day 8 till hCG Day
Primary Outcome Measure Information:
Title
Number of oocyte retrieved
Time Frame
2009Dec-2010Oct
Secondary Outcome Measure Information:
Title
1. Oestrodial on hCG day (pg/ml) Safety: adverse events
Time Frame
2009 Dec-2010 Oct
Title
2. Number of embryos
Time Frame
2009 Dec-2010 Oct
Title
3. Implantation rate (%)
Time Frame
2009 Dec-2010 Oct
Title
4. Clinical pregnancy rate (%)
Time Frame
2009 Dec-2010 Oct
Title
5. Ongoing PR per IVF cycle (%)
Time Frame
2009 Dec-2010 Oct
Title
6. Abortion rate (%)
Time Frame
2009 Dec-2010 Oct
Title
7. Ampoules of rFSH
Time Frame
2009 Dec-2010 Oct
Title
8. FertiQoL score Safety: adverse events
Time Frame
2009 Dec-2010 Oct

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Qiao, MD, PHD
Phone
86-10-82266699
Email
qiaojiebu3h@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Qiao, MD, PhD
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Qiao, MD, PHD
Phone
86-10-82266699
First Name & Middle Initial & Last Name & Degree
Jie Qiao, MD, PHD

12. IPD Sharing Statement

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To Describe the Effect of rhLH Supplementation in Women With Hyporesponse to rhFSH After Pituitary Downregulation

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