To Describe the Effect of rhLH Supplementation in Women With Hyporesponse to rhFSH After Pituitary Downregulation
NCT ID: NCT01029470
Last Updated: 2009-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
150 participants
INTERVENTIONAL
2009-12-31
2011-03-31
Brief Summary
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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
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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
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Luveris
Luveris 75IU or 150IU depending on the patient conditions, subcutaneous injection, Qd, from Day 8 till hCG Day
Interventions
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Luveris
Luveris 75IU or 150IU depending on the patient conditions, subcutaneous injection, Qd, from Day 8 till hCG Day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. rAFS stage Ⅲ-Ⅳ endometriosis
3. Chromosomal abnormalities, endocrinological and/or autoimmune disorders.
4. More than two previously unsuccessful IVF.
20 Years
40 Years
FEMALE
No
Sponsors
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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
Reproductive & Genetic Hospital of CITIC-Xiangya
OTHER
Peking University Third Hospital
OTHER
Responsible Party
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Peking University Third Hospital Reproductive Medical Center
Principal Investigators
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Jie Qiao, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University Third Hospital
Locations
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Peking University third Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Jie Qiao, MD, PHD
Role: primary
Other Identifiers
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EMR700642-606
Identifier Type: -
Identifier Source: org_study_id