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Comparison of Ovarian Mild Stimulation and Controlled Ovarian Stimulation in Poor Ovarian Responders (POR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01926210
Recruitment Status : Unknown
Verified August 2013 by Huang Rui, Sun Yat-sen University.
Recruitment status was:  Not yet recruiting
First Posted : August 20, 2013
Last Update Posted : August 21, 2013
Sponsor:
Information provided by (Responsible Party):
Huang Rui, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE August 14, 2013
First Posted Date  ICMJE August 20, 2013
Last Update Posted Date August 21, 2013
Study Start Date  ICMJE September 2013
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2013)
clinical pregnancy rate [ Time Frame: 7 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01926210 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2013)
  • live birth rate [ Time Frame: 10 months ]
  • Number of oocytes retrieved [ Time Frame: 3 weeks ]
  • Number of transferrable embryo [ Time Frame: 3 weeks ]
  • normal fertilization rate [ Time Frame: 3 weeks ]
  • implantation rate [ Time Frame: 7 weeks ]
  • ongoing pregnancy rate [ Time Frame: 3 months ]
  • Total dose of recombinant FSH consumption [ Time Frame: 3 weeks ]
  • length of stimulation [ Time Frame: 3 weeks ]
  • serum estradiol level [ Time Frame: 3 weeks ]
  • serum LH level [ Time Frame: 3 weeks ]
  • serum progesterone level [ Time Frame: 3 weeks ]
  • serum FSH level [ Time Frame: 3 weeks ]
  • FSH level in follicular fluid [ Time Frame: 3 weeks ]
  • LH level in follicular fluid [ Time Frame: 3 weeks ]
  • Estradiol level in the follicular fluid [ Time Frame: 3 weeks ]
  • progesterone level in follicular fluid [ Time Frame: 3 weeks ]
  • testerone level in the follicular fluid [ Time Frame: 3 weeks ]
  • anti-müllerian hormone (AMH)level in follicular fluid [ Time Frame: 3 weeks ]
  • Ovarian Hyperstimulation Syndrome (OHSS) rate [ Time Frame: 7 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Ovarian Mild Stimulation and Controlled Ovarian Stimulation in Poor Ovarian Responders
Official Title  ICMJE The Comparison of Mild Stimulation and Controlled Ovarian Stimulation in Poor Ovarian Responders: a Prospective Randomized Study.
Brief Summary This is a prospective, randomized clinical trial to compare the efficiency and safety of mild stimulation and controlled ovarian stimulation protocol on the treatment of POR. The randomization is achieved on the basis of a computer-generated randomization list in a 1:1 ratio.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE
  • Other: mild stimulation protocol
    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:
    • letrozole
    • recombinant FSH
    • GnRH antagonist
  • Other: controlled ovarian stimulation
    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:
    • GnRH agonist
    • recombinant FSH
Study Arms  ICMJE
  • 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.
    Intervention: Other: mild stimulation protocol
  • 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.
    Intervention: Other: controlled ovarian stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 16, 2013)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2016
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01926210
Other Study ID Numbers  ICMJE A-2013-01-05S
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Huang Rui, Sun Yat-sen University
Study Sponsor  ICMJE Huang Rui
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rui Huang, M.D. sixth affiliated hospital of Sun Yet-san University
PRS Account Sun Yat-sen University
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP