InfertilityNCT03914651
CLBR Per Initial Cycle With Different Starting Dose in Aged Patients With Poor Ovarian Reservation: 300IU Versus 150IU
A study of Infertility, run by Reproductive & Genetic Hospital of CITIC-Xiangya at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 42 years, women only
- Conditions the study is for
- Infertility
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 23 Apr 2019to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age Limits≥35 and≤42；
- AFC≤5 or AMH≤1.2ng/ml；
- BMI≤30kg/m2；
- The first IVF/intracytoplasmic sperm injection （ICSI） cycle；
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Reproductive & Genetic Hospital of CITIC-XIANGYA
Changsha, Hunan, 410008
Xiaofeng Li, doctor, 0731-82355100, xiaofeng_citic@sina.com
Fei Gong, PhD
About this study
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
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.
- Conditions
- Infertility
- Being tested
- 300IU rFSH Gonal-F® starting dose during controlled ovarian stimulation, 150IU rFSH Gonal-F® starting dose during controlled ovarian stimulation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
300IU rFSH Gonal-F® starting dose during controlled ovarian stimulationDrug
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）.
150IU rFSH Gonal-F® starting dose during controlled ovarian stimulationDrug
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 group | Role | What they receive |
|---|---|---|
| 300IU rFSH stimulation group | Active comparator | 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. Receives: Drug: 300IU rFSH Gonal-F® starting dose during controlled ovarian stimulation |
| 150IU rFSH stimulation group | Experimental | 150IU rFSH Gonal-F® stimulation group is defined as patients using GnRH antagonist protocol with a 150IU rFSH starting dose during controlled ovarian stimulation. Receives: Drug: 150IU rFSH Gonal-F® starting dose during controlled ovarian stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 22 months
Secondary outcomes (10)
Time to live birth
Time to live birth is defined as the interval between the date of randomization and achieving live birth.
Measured: 22 months
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.
Measured: 1 month
Number of MII eggs
MII eggs is defined as eggs retrieved that reach the MII phase.
Measured: 1 month
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.
Measured: 14 months
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).
Measured: 19 months
Implantation rate
Number of gestation sac detected / number of embryo transferred.
Measured: 14 months
Multiple pregnancy rate
Number of multiple pregnancies / number of clinical pregnancies over (up to) 3 transfers within 1 year.
Measured: 22 months
Neonatal malformation rate
Number of infant diagnosed as neonatal malformation / the total number of infant delivered after 28 weeks of gestation.
Measured: 22 months
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.
Measured: 1 month
Birth weight
Weight of newborns at delivery
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start23 Apr 2019
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-Xiangya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914651
- Sponsor's protocol ID
- P2019002
- Status last verified
- Jan 2022
- First submitted
- 11 Apr 2019
- Last updated
- 12 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03914651
- Acronym / sponsor ID
- P2019002
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-XiangyaUniversity, hospital or other
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 300IU rFSH stimulation group | Active comparator | Drug: 300IU rFSH Gonal-F® starting dose during controlled ovarian stimulation300IU 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 stimulation group | Experimental | Drug: 150IU rFSH Gonal-F® starting dose during controlled ovarian stimulation150IU rFSH Gonal-F® stimulation group is defined as patients using GnRH antagonist protocol with a 150IU rFSH starting dose during controlled ovarian stimulation. |
Who may qualify
- Ages
- 35 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age Limits≥35 and≤42；
- AFC≤5 or AMH≤1.2ng/ml；
- BMI≤30kg/m2；
- The first IVF/intracytoplasmic sperm injection （ICSI） cycle；
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 300IU rFSH Gonal-F® starting dose during controlled ovarian stimulationOn 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 | 300IU rFSH stimulation group |
| 150IU rFSH Gonal-F® starting dose during controlled ovarian stimulationOn 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. | Drug | 150IU rFSH stimulation group |
Primary outcome
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.
10 secondary outcomes
Time to live birth
Time frame: 22 months
Cycle cancellation rate
Time frame: 1 month
Number of MII eggs
Time frame: 1 month
Cumulative Clinic pregnancy rate
Time frame: 14 months
cumulative pregnancy loss rate
Time frame: 19 months
Implantation rate
Time frame: 14 months
Multiple pregnancy rate
Time frame: 22 months
Neonatal malformation rate
Time frame: 22 months
Good quality embryo rate
Time frame: 1 month
Birth weight
Time frame: 22 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Infertility, run by Reproductive & Genetic Hospital of CITIC-Xiangya at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative live birth rate (time frame: 22 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2022; AzTrials last refreshed its copy on 30 Oct 2026.