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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01029470
Enrollment
150
Registered
2009-12-10
Start date
2009-12-31
Completion date
2011-03-31
Last updated
2009-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

Luveris, hyporesponse, pituitary downregulation, IVF, Infertility women

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

Interventions

DRUGLuveris

Luveris 75IU or 150IU depending on the patient conditions, subcutaneous injection, Qd, from Day 8 till hCG Day

Sponsors

Peking Union Medical College Hospital
CollaboratorOTHER
Chongqing Medical Center for Women and Children
CollaboratorOTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
CollaboratorOTHER
Reproductive & Genetic Hospital of CITIC-Xiangya
CollaboratorOTHER
Peking University Third Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Number of oocyte retrieved2009Dec-2010Oct

Secondary

MeasureTime frame
2. Number of embryos2009 Dec-2010 Oct
3. Implantation rate (%)2009 Dec-2010 Oct
4. Clinical pregnancy rate (%)2009 Dec-2010 Oct
1. Oestrodial on hCG day (pg/ml) Safety: adverse events2009 Dec-2010 Oct
6. Abortion rate (%)2009 Dec-2010 Oct
7. Ampoules of rFSH2009 Dec-2010 Oct
8. FertiQoL score Safety: adverse events2009 Dec-2010 Oct
5. Ongoing PR per IVF cycle (%)2009 Dec-2010 Oct

Countries

China

Contacts

Primary ContactJie Qiao, MD, PHD
qiaojiebu3h@163.com86-10-82266699

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026