Back to resultsCLBR Per Initial Cycle With Different Starting Dose in Aged Patients With Poor Ovarian Reservation: 300IU Versus 150IU
Primary Purpose
Infertility
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
300IU rFSH Gonal-F® starting dose during controlled ovarian stimulation
150IU rFSH Gonal-F® starting dose during controlled ovarian stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- Age Limits≥35 and≤42；
- AFC≤5 or AMH≤1.2ng/ml；
- BMI≤30kg/m2；
- The first IVF/intracytoplasmic sperm injection （ICSI） cycle；
Exclusion Criteria:
- Any other underlying disease or condition considered IVF is contraindicated.
- Ovarian hyperstimulation syndrome（PCOS）, moderate or severe intrauterine adhesion，untreated hydrosalpinx, adenomyosis， any myoma in cases that endometrium was affected, intramural larger than 4cm.
- Autoimmune antibody positive, untreated.
- History of recurrent miscarriages.
- Patients seeking for Preimplantation Genetic Testing(PGT) treatment.
- Simultaneous participation in another clinical study.
- According to the judgment of the investigator, any reason or condition that precludes subject for participating in the study.
Sites / Locations
- Reproductive & Genetic Hospital of CITIC-XIANGYARecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
300IU rFSH stimulation group
150IU rFSH stimulation group
Arm Description
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.
150IU rFSH Gonal-F® stimulation group is defined as patients using GnRH antagonist protocol with a 150IU rFSH starting dose during controlled ovarian stimulation.
Outcomes
Primary Outcome Measures
Cumulative live birth rate
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
Time to live birth
Time to live birth is defined as the interval between the date of randomization and achieving live birth.
Cycle cancellation rate
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
MII eggs is defined as eggs retrieved that reach the MII phase.
Cumulative Clinic pregnancy rate
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
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
Number of gestation sac detected / number of embryo transferred.
Multiple pregnancy rate
Number of multiple pregnancies / number of clinical pregnancies over (up to) 3 transfers within 1 year.
Neonatal malformation rate
Number of infant diagnosed as neonatal malformation / the total number of infant delivered after 28 weeks of gestation.
Good quality embryo rate
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
Weight of newborns at delivery
Full Information
NCT ID
NCT03914651
First Posted
April 11, 2019
Last Updated
January 10, 2022
Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya
1. Study Identification
Unique Protocol Identification Number
NCT03914651
Brief Title
CLBR Per Initial Cycle With Different Starting Dose in Aged Patients With Poor Ovarian Reservation: 300IU Versus 150IU
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 23, 2019 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
300IU rFSH stimulation group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
150IU rFSH stimulation group
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
300IU rFSH Gonal-F® starting dose during controlled ovarian stimulation
Intervention Description
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）.
Intervention Type
Drug
Intervention Name(s)
150IU rFSH Gonal-F® starting dose during controlled ovarian stimulation
Intervention Description
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 Measure Information:
Title
Cumulative live birth rate
Description
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.
Time Frame
22 months
Secondary Outcome Measure Information:
Title
Time to live birth
Description
Time to live birth is defined as the interval between the date of randomization and achieving live birth.
Time Frame
22 months
Title
Cycle cancellation rate
Description
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.
Time Frame
1 month
Title
Number of MII eggs
Description
MII eggs is defined as eggs retrieved that reach the MII phase.
Time Frame
1 month
Title
Cumulative Clinic pregnancy rate
Description
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.
Time Frame
14 months
Title
cumulative pregnancy loss rate
Description
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).
Time Frame
19 months
Title
Implantation rate
Description
Number of gestation sac detected / number of embryo transferred.
Time Frame
14 months
Title
Multiple pregnancy rate
Description
Number of multiple pregnancies / number of clinical pregnancies over (up to) 3 transfers within 1 year.
Time Frame
22 months
Title
Neonatal malformation rate
Description
Number of infant diagnosed as neonatal malformation / the total number of infant delivered after 28 weeks of gestation.
Time Frame
22 months
Title
Good quality embryo rate
Description
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.
Time Frame
1 month
Title
Birth weight
Description
Weight of newborns at delivery
Time Frame
22 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age Limits≥35 and≤42；
AFC≤5 or AMH≤1.2ng/ml；
BMI≤30kg/m2；
The first IVF/intracytoplasmic sperm injection （ICSI） cycle；
Exclusion Criteria:
Any other underlying disease or condition considered IVF is contraindicated.
Ovarian hyperstimulation syndrome（PCOS）, moderate or severe intrauterine adhesion，untreated hydrosalpinx, adenomyosis， any myoma in cases that endometrium was affected, intramural larger than 4cm.
Autoimmune antibody positive, untreated.
History of recurrent miscarriages.
Patients seeking for Preimplantation Genetic Testing(PGT) treatment.
Simultaneous participation in another clinical study.
According to the judgment of the investigator, any reason or condition that precludes subject for participating in the study.
Facility Information:
Facility Name
Reproductive & Genetic Hospital of CITIC-XIANGYA
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaofeng Li, doctor
Phone
0731-82355100
Email
xiaofeng_citic@sina.com
First Name & Middle Initial & Last Name & Degree
Fei Gong, PhD
12. IPD Sharing Statement
Learn more about this trial
CLBR Per Initial Cycle With Different Starting Dose in Aged Patients With Poor Ovarian Reservation: 300IU Versus 150IU
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