To Describe the Effect of rhLH Supplementation in Women W... | NCT01029470

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

NCT01029470

Sponsor

Peking University Third Hospital

Status

Unknown status

Last Update Posted

Dec 10, 2009Estimated

Enrollment

150Estimated

Phase

Phase 2

Conditions

Infertility

Interventions

Luveris

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Oct 2010Estimated

Completion Date

Mar 2011Estimated

First Submitted Date

Dec 9, 2009

First Submission Date that Met QC Criteria

Dec 9, 2009

First Posted Date

Dec 10, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2009

Last Update Posted Date

Dec 10, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Peking University Third HospitalOTHER

Collaborators

Name	Class
Peking Union Medical College Hospital	OTHER
Chongqing Medical Center for Women and Children	OTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Drug: Luveris

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Luveris	Drug	Luveris 75IU or 150IU depending on the patient conditions, subcutaneous injection, Qd, from Day 8 till hCG Day	Luveris

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of oocyte retrieved		2009Dec-2010Oct

Secondary Outcomes

Measure	Description	Time Frame
1. Oestrodial on hCG day (pg/ml) Safety: adverse events		2009 Dec-2010 Oct
2. Number of embryos		2009 Dec-2010 Oct
3. Implantation rate (%)

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jie Qiao, MD, PHD	Contact	86-10-82266699		qiaojiebu3h@163.com

Overall Officials

Name	Affiliation	Role
Jie Qiao, MD, PhD	Peking University Third Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University third Hospital		Beijing	Beijing Municipality	100191	China

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D037101	Luteinizing Hormone, beta Subunit
C571801	follitropin alfa
C412828	Ovidrel

Ancestor Terms

ID	Term
D007986	Luteinizing Hormone
D006065	Gonadotropins, Pituitary
D006062	Gonadotropins
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided