- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03914651
CLBR Per Initial Cycle With Different Starting Dose in Aged Patients With Poor Ovarian Reservation: 300IU Versus 150IU
January 10, 2022 updated by: Reproductive & Genetic Hospital of CITIC-Xiangya
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
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Anticipated)
260
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Hunan
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Changsha, Hunan, China, 410008
- Recruiting
- Reproductive & Genetic Hospital of Citic-Xiangya
-
Contact:
- Xiaofeng Li, doctor
- Phone Number: 0731-82355100
- Email: xiaofeng_citic@sina.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 42 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
22 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
22 months
|
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.
|
1 month
|
Number of MII eggs
Time Frame: 1 month
|
MII eggs is defined as eggs retrieved that reach the MII phase.
|
1 month
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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.
|
14 months
|
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).
|
19 months
|
Implantation rate
Time Frame: 14 months
|
Number of gestation sac detected / number of embryo transferred.
|
14 months
|
Multiple pregnancy rate
Time Frame: 22 months
|
Number of multiple pregnancies / number of clinical pregnancies over (up to) 3 transfers within 1 year.
|
22 months
|
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.
|
22 months
|
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.
|
1 month
|
Birth weight
Time Frame: 22 months
|
Weight of newborns at delivery
|
22 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 23, 2019
Primary Completion (ANTICIPATED)
December 30, 2022
Study Completion (ANTICIPATED)
December 30, 2022
Study Registration Dates
First Submitted
April 11, 2019
First Submitted That Met QC Criteria
April 11, 2019
First Posted (ACTUAL)
April 16, 2019
Study Record Updates
Last Update Posted (ACTUAL)
January 12, 2022
Last Update Submitted That Met QC Criteria
January 10, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P2019002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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