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

Study Overview
=================
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

Official Title
-----------------
A Multicentre, Prospective, Open Study to Describe the Effects of rhLH Supplement in Women With Hyporesponse to rFSH After Pituitary Downregulation.

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: Luveris


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Luveris<br>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<br>* Luveris 75IU or 150IU depending on the patient conditions, subcutaneous injection, Qd, from Day 8 till hCG Day<br>* Other names: Gonal-f, ovidrel;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | 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 (%) |  | 2009 Dec-2010 Oct | 
| 4. Clinical pregnancy rate (%) |  | 2009 Dec-2010 Oct | 
| 5. Ongoing PR per IVF cycle (%) |  | 2009 Dec-2010 Oct | 
| 6. Abortion rate (%) |  | 2009 Dec-2010 Oct | 
| 7. Ampoules of rFSH |  | 2009 Dec-2010 Oct | 
| 8. FertiQoL score Safety: adverse events |  | 2009 Dec-2010 Oct | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Luveris, hyporesponse, pituitary downregulation, IVF, Infertility women