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

Phase 2

• Conditions: Infertility
• Interventions: Drug: Luveris

• Registration Number: NCT01029470
• Lead Sponsor: Peking University Third Hospital

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:

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

Study Timeline

• Status Verified: 2009-12
• Study Start: 2009-12
• Study First Submitted: 2009-12-09
• Study First Submitted QC: 2009-12-09
• Last Update Submitted: 2009-12-09
• Study First Posted: 2009-12-10
• Last Update Posted: 2009-12-10
• Primary Completion: 2010-10
• Study Completion: 2011-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Luveris	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.

Primary Outcome Measures

Name	Time	Method
Number of oocyte retrieved	2009Dec-2010Oct

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking University third Hospital; 🇨🇳 Beijing, Beijing, China