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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

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.

Condition or disease Intervention/treatment Phase
Infertility Drug: 300IU rFSH Gonal-F® starting dose during controlled ovarian stimulation Drug: 150IU rFSH Gonal-F® starting dose during controlled ovarian stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 23, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2021

Arm Intervention/treatment
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.
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).

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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Number of MII eggs [ Time Frame: 1 month ]
    MII eggs is defined as eggs retrieved that reach the MII phase.

  4. 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.

  5. 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).

  6. Implantation rate [ Time Frame: 14 months ]
    Number of gestation sac detected / number of embryo transferred.

  7. Multiple pregnancy rate [ Time Frame: 22 months ]
    Number of multiple pregnancies / number of clinical pregnancies over (up to) 3 transfers within 1 year.

  8. 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.

  9. 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.

  10. Birth weight [ Time Frame: 22 months ]
    Weight of newborns at delivery



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Ages Eligible for Study:   35 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914651


Locations
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China, Hunan
Reproductive & Genetic Hospital of CITIC-XIANGYA Recruiting
Changsha, Hunan, China, 410008
Contact: Xiaofeng Li, doctor    0731-82355100    xiaofeng_citic@sina.com   
Sponsors and Collaborators
Reproductive & Genetic Hospital of CITIC-Xiangya

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Responsible Party: Reproductive & Genetic Hospital of CITIC-Xiangya
ClinicalTrials.gov Identifier: NCT03914651     History of Changes
Other Study ID Numbers: P2019002
First Posted: April 15, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female