- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01926210
Comparison of Ovarian Mild Stimulation and Controlled Ovarian Stimulation in Poor Ovarian Responders (POR)
The Comparison of Mild Stimulation and Controlled Ovarian Stimulation in Poor Ovarian Responders: a Prospective Randomized Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
500 poor ovarian responders will be equally randomized to two different ovarian stimulation protocol arms,i.e, mild ovarian stimulation(experimental arm) or controlled ovarian stimulation(control arm). In experimental arm, patients will received letrozole 5mg per day from cycle day 3 to 7 and recombinant follicle-stimulating hormone (FSH) 150 international unit (IU) on day 4 and 6. The dose of recombinant FSH is adjusted according to the ovarian response and the gonadotropin-releasing hormone(GnRH)antagonist(Cetrotide) 0.25mg per day is administrated when the estradiol level reaches 200 pg/ml and the serum luteinizing hormone (LH)level rises above 2 times of basal LH level. In control arm,patients will be stimulated with short-acting GnRH agonist long protocol. After complete downregulation is achieved through GnRH-agonist, recombinant FSH 300 IU/d is given for 5 days, then the dose of recombinant FSH is adjusted according to ovarian response.
The clinical and ongoing pregnancy rate and other secondary outcome parameters are compared between these two groups.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Xing Yang, M.D.
- Email: yxing8358@gmail.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510010
- sixth affiliated hospital of Sun Yet-san University
-
Contact:
- Yu Deng, M.D.
- Email: dengyu1983@yahoo.com.cn
-
Principal Investigator:
- Rui Huang, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- a. Poor ovarian responders b. Normal BMI (18-25 Kg/m2) c. Regular menstruation (with cycle 23-35 days)
Exclusion Criteria:
- a. History of repeated IVF failure (previous IVF cycle >2) b. Serious adenomyosis c. Polycystic ovary syndrome(PCOS) patients d. History of allergic to ovulation induction medicines e. Abnormal uterine cavity, i.e, intrauterine adhesion f. Attending other clinical trials in the same period. g. History of systemic disease contradictory to COH or pregnancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: mild ovarian stimulation
Patients are stimulated with mild ovarian stimulation protocol,i.ed,
from cycle day 3 to 7, letrozole 5mg per day are administrated and recombinant FSH 150 IU are given on day 4 and 6 .
On cycle day 8, serum FSH LH, and estradiol levels are measured, and after then, the dose of recombinant FSH is adjusted according to the ovarian response and the maxim recombinant FSH dose is 150 IU/d.
The GnRH-antagonist (Cetrotide) 0.25mg per day is administrated when the estradiol level reaches 200 pg/ml and the serum LH level rises above 2 times of basal LH level.
|
letrozole is used from cycle day 3 to 7 and low dose recombinant FSH(no more than 150 IU/d) is used on cycle day 4,6 and 8 onwards.
GnRH antagonist is only applied in case of premature LH rise might happen.
Other Names:
|
Active Comparator: controlled ovarian stimulation
Patients are stimulated using controlled ovarian stimulation protocol,i.e., from cycle day 18-22 (day 7 after ovulation) of previous cycle, all participants are given short-acting GnRH agonist (Triptorelin 0.05mg/d) for 14 days, then after checking serum FSH, LH and estradiol to make sure that complete downregulation is achieved, exogenous gonadotropin (recombinant FSH) 300 IU/d is given for 5 days, then the dose of recombinant FSH is adjusted according to ovarian response.
|
After fully downregulation by using short-acting GnRH agonist, 300 IU/d recombinant FSH is administrated for 5 days, then the dose is adjusted according to ovarian response.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
clinical pregnancy rate
Time Frame: 7 weeks
|
7 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
live birth rate
Time Frame: 10 months
|
10 months
|
Number of oocytes retrieved
Time Frame: 3 weeks
|
3 weeks
|
Number of transferrable embryo
Time Frame: 3 weeks
|
3 weeks
|
normal fertilization rate
Time Frame: 3 weeks
|
3 weeks
|
implantation rate
Time Frame: 7 weeks
|
7 weeks
|
ongoing pregnancy rate
Time Frame: 3 months
|
3 months
|
Total dose of recombinant FSH consumption
Time Frame: 3 weeks
|
3 weeks
|
length of stimulation
Time Frame: 3 weeks
|
3 weeks
|
serum estradiol level
Time Frame: 3 weeks
|
3 weeks
|
serum LH level
Time Frame: 3 weeks
|
3 weeks
|
serum progesterone level
Time Frame: 3 weeks
|
3 weeks
|
serum FSH level
Time Frame: 3 weeks
|
3 weeks
|
FSH level in follicular fluid
Time Frame: 3 weeks
|
3 weeks
|
LH level in follicular fluid
Time Frame: 3 weeks
|
3 weeks
|
Estradiol level in the follicular fluid
Time Frame: 3 weeks
|
3 weeks
|
progesterone level in follicular fluid
Time Frame: 3 weeks
|
3 weeks
|
testerone level in the follicular fluid
Time Frame: 3 weeks
|
3 weeks
|
anti-müllerian hormone (AMH)level in follicular fluid
Time Frame: 3 weeks
|
3 weeks
|
Ovarian Hyperstimulation Syndrome (OHSS) rate
Time Frame: 7 weeks
|
7 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rui Huang, M.D., sixth affiliated hospital of Sun Yet-san University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A-2013-01-05S
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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