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CLBR Per Initial Cycle With Different Starting Dose in Aged Patients With Poor Ovarian Reservation: 300IU Versus 150IU

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ClinicalTrials.gov Identifier: NCT03914651
Recruitment Status : Recruiting
First Posted : April 15, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Reproductive & Genetic Hospital of CITIC-Xiangya

Tracking Information
First Submitted Date  ICMJE April 11, 2019
First Posted Date  ICMJE April 15, 2019
Last Update Posted Date May 14, 2019
Actual Study Start Date  ICMJE April 23, 2019
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2019)
Cumulative live birth rate [ Time Frame: 22 months ]
Live birth is defined as the delivery of any viable infant at 28 weeks or more of gestation after our interventions。And cumulative live birth rate is calculated by dividing the number of women achieving live birth after transfers of all study-specific embryos (within 1 year after randomization) by the total number of women randomized to the specific group.
Original Primary Outcome Measures  ICMJE
 (submitted: April 11, 2019)
Cumulative live birth rate [ Time Frame: 2 year ]
Change History Complete list of historical versions of study NCT03914651 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2019)
  • Time to live birth [ Time Frame: 22 months ]
    Time to live birth is defined as the interval between the date of randomization and achieving live birth.
  • Cycle cancellation rate [ Time Frame: 1 month ]
    Cycle cancellation is defined as cycle cancelled before obtaining at least one viable embryo for any reason. And cycle cancellation rate is calculated by dividing the number of women cancelled their cycle before obtaining at least one viable embryo for any reason by the total number of women randomized to the specific group.
  • Number of MII eggs [ Time Frame: 1 month ]
    MII eggs is defined as eggs retrieved that reach the MII phase.
  • Cumulative Clinic pregnancy rate [ Time Frame: 14 months ]
    Clinic pregnancy will be diagnosed with the detection of an intrauterine gestation sac. And cumulative clinic pregnancy rate is calculated by the number of women who achieves clinical pregnancy after transfers of all study-specific embryos (within 1 year after randomization) by the total number of women randomized to the specific group.
  • cumulative pregnancy loss rate [ Time Frame: 19 months ]
    Pregnancy loss is defined as a complete spontaneous abortion or a nonviable pregnancy before 28 weeks of gestation. And cumulative pregnancy loss rate is calculated as the number of pregnancy losses / number of clinical pregnancy after transfers of all study-specific embryos (within 1 year after randomization).
  • Implantation rate [ Time Frame: 14 months ]
    Number of gestation sac detected / number of embryo transferred.
  • Multiple pregnancy rate [ Time Frame: 22 months ]
    Number of multiple pregnancies / number of clinical pregnancies over (up to) 3 transfers within 1 year.
  • Neonatal malformation rate [ Time Frame: 22 months ]
    Number of infant diagnosed as neonatal malformation / the total number of infant delivered after 28 weeks of gestation.
  • Good quality embryo rate [ Time Frame: 1 month ]
    Good quality embryo is defined as embryo that is graded as 6CII or better or blastocyst. And good quality embryo rate is calculated by dividing the number of good quality embryo by the total number of embryo obtained after fertilization in the specific group.
  • Birth weight [ Time Frame: 22 months ]
    Weight of newborns at delivery
Original Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2019)
  • Time to live birth [ Time Frame: 2 year ]
  • Cycle cancellation rate [ Time Frame: 1 year ]
  • Number of MII eggs [ Time Frame: 1 year ]
  • Clinic pregnancy rate [ Time Frame: 1 year ]
  • Abortion rate [ Time Frame: 1 year ]
  • Ectopic pregnancy rate [ Time Frame: 1 year ]
  • Implantation rate [ Time Frame: 1 year ]
  • Multiple pregnancy rate [ Time Frame: 1 year ]
  • Neonatal malformation rate [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CLBR Per Initial Cycle With Different Starting Dose in Aged Patients With Poor Ovarian Reservation: 300IU Versus 150IU
Official Title  ICMJE Comparison of Cumulative Live Birth Rate Per Initial Cycle Between 300 IU and 150IU Starting Dose of rFSH Among Aged Patients With Poor Ovarian Reservation: a Randomized Controlled Trail
Brief Summary Among aged patients with poor ovarian reservation(defined as age 35 to 42 years; antral follicle count(AFC)≤ 5 or anti-mullerian hormone(AMH)≤ 1.2 ng/ml), cumulative live birth rate(CLBR) and time to live birth(TTLB) of the first stimulation cycle were compared between a starting dose of 300IU or 150IU rFSH in controlled ovarian stimulation with gonadotropin-releasing hormone(GnRH)antagonist protocol. This study is a prospective randomized controlled trial.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE
  • Drug: 300IU rFSH Gonal-F® starting dose during controlled ovarian stimulation
    On menstrual cycle day 2 or day 3, 300IU rFSH Gonal-F® will be administrated daily till the day of trigger. The dosage of rFSH can be adjusted only if there is a risk of ovarian hyperstimulation syndrome(OHSS).
  • Drug: 150IU rFSH Gonal-F® starting dose during controlled ovarian stimulation
    On menstrual cycle day 2 or day 3, 150IU rFSH Gonal-F® will be administrated daily till the day of trigger. The dosage of rFSH can be adjusted only if there is a risk of OHSS or insufficient follicular growth.
Study Arms  ICMJE
  • Active Comparator: 300IU rFSH stimulation group
    300IU rFSH stimulation group is defined as patients using gonadotropin-releasing hormone(GnRH)antagonist protocol with a 300IU rFSH Gonal-F® starting dose during controlled ovarian stimulation.
    Intervention: Drug: 300IU rFSH Gonal-F® starting dose during controlled ovarian stimulation
  • Experimental: 150IU rFSH stimulation group
    150IU rFSH Gonal-F® stimulation group is defined as patients using GnRH antagonist protocol with a 150IU rFSH starting dose during controlled ovarian stimulation.
    Intervention: Drug: 150IU rFSH Gonal-F® starting dose during 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 11, 2019)
260
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2021
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age Limits≥35 and≤42;
  2. AFC≤5 or AMH≤1.2ng/ml;
  3. BMI≤30kg/m2;
  4. The first IVF/intracytoplasmic sperm injection (ICSI) cycle;

Exclusion Criteria:

  1. Any other underlying disease or condition considered IVF is contraindicated.
  2. Ovarian hyperstimulation syndrome(PCOS), moderate or severe intrauterine adhesion,untreated hydrosalpinx, adenomyosis, any myoma in cases that endometrium was affected, intramural larger than 4cm.
  3. Autoimmune antibody positive, untreated.
  4. History of recurrent miscarriages.
  5. Patients seeking for Preimplantation Genetic Testing(PGT) treatment.
  6. Simultaneous participation in another clinical study.
  7. According to the judgment of the investigator, any reason or condition that precludes subject for participating in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 35 Years to 42 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03914651
Other Study ID Numbers  ICMJE P2019002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Reproductive & Genetic Hospital of CITIC-Xiangya
Study Sponsor  ICMJE Reproductive & Genetic Hospital of CITIC-Xiangya
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Reproductive & Genetic Hospital of CITIC-Xiangya
Verification Date May 2019

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