SterilityCLBRNCT04026282
To Investigate the Cumulative Live Birth Rates Using GnRH Antagonist or Agonist Protocol for COS in ART Treatment
A study testing GnRH-ant protocol and GnRH-a long protocol in people with Sterility, run by Peking University Third Hospital at 4 sites in China.
Trial summary
This is a Phase IV, prospective, randomized controlled study to investigate the cumulative live birth rates (CLBRs) of gonadotrophin-releasing hormone (GnRH) antagonist protocol (GnRH-ant group) compared with the standard GnRH agonist long protocol (GnRH-a group) for controlled ovarian stimulation in supposed normal… Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Sterility
- What is being tested?
- GnRH-ant protocol and GnRH-a long protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 888 participants
- Where
- 4 sitesChina
- Study dates
- 27 Dec 2018to 31 Jul 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 18 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertile women planning to undergo IVF/ICSI cycle using conventional GnRH agonist long protocol or GnRH antagonist protocol
- Age ≤ 38 years old
- Basal AFC 8~20
- Basal FSH≤10 IU/L
- Basal E 2 <200pmol/L
- Normal uterus and at least one side of the normal ovary
- Informed consent form signed
- Willing to follow the study protocol, and able to complete this study
Who cannot join
- Previous IVF/ICSI cycles >2
- Severe hydro-salpinx (Ultrasound shows hydro salpinx﹥2cm)
- Severe endometriosis (Grade III - IV)
- Polycystic ovarian syndrome (PCOS)
- History of recurrent miscarriages (>2 times of miscarriages)
- Plan to undergo ovarian stimulation for preimplantation genetic diagnosis or preimplantation genetic screening, oocyte donation, and social or medical freezing of oocytes
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- Any major systemic disease that as per Investigator's discretion precludes subject for participation in the study
- With pregnancy contraindications
- Alcoholism, drug abuse, drug addiction or patients with uncured sexually transmitted disease
- According to the judgment of the Investigator, any medical condition or any concomitant surgery/medications that would interfere with evaluation of study medications
- Simultaneous participation in another clinical study
- Plan to use urinary gonadotrophin during COS treatment
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
The second hospital of Hebei Medical University
Baoding, Hebei, 300000
Jiamin Hao
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100000
Jie Qiao, 010-82265080, jie.qiao@263.net
- Recruiting
Jiangsu Provincial Hospital
Nanjing, Zhejiang, 210000
Feiyang Diao, phenix_y@163.com
- Recruiting
The third hospital of Zhengzhoui Medical University
Zhengzhou, Henan, 450000
Xingling Wang
About this study
Official title: A Prospective, Randomized Controlled Study to Investigate the CLBRs of GnRH Antagonist Protocol Compared With the Standard GnRH Agonist Long Protocol for Controlled Ovarian Stimulation in Supposed Normal Ovarian Responders
This is a Phase IV, prospective, randomized controlled study to investigate the cumulative live birth rates (CLBRs) of gonadotrophin-releasing hormone (GnRH) antagonist protocol (GnRH-ant group) compared with the standard GnRH agonist long protocol (GnRH-a group) for controlled ovarian stimulation in supposed normal ovarian responders.
Read the detailed description
This is a Phase IV, prospective, randomized controlled study to investigate the cumulative live birth rates (CLBRs) of gonadotrophin-releasing hormone (GnRH) antagonist protocol (GnRH-ant group) compared with the standard GnRH agonist long protocol (GnRH-a group) for controlled ovarian stimulation in supposed normal ovarian responders.
In this study, patients who are planning to undergo IVF/ICSI cycle aged ≤38 years old with normal ovarian reserve will be considered for enrollment. Approximately 888 patients will be enrolled at approximately 5 centers in China over a period of 10 months.
About 12-20 visits will be performed in this study for each patient. The CLBR with first live birth resulting from one initiated COS cycle will be compared between GnRH-a group and GnRH-ant group.
- Conditions
- Sterility
- Being tested
- GnRH-ant protocol, GnRH-a long protocol
- Keywords
- assisted reproductive technology, live birth, fertilization
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GnRH-ant protocolProcedure or surgery
Recombinant FSH (Gonal-f®) will be administrated as routinely practiced by investigators. FSH doses will be adjusted according to the clinical experiences of investigators.The GnRH-ant (Cetrotide®) will be initiated in a fixed protocol on stimulation days 5 or 6 per the investigator's ART protocol.
GnRH-a long protocolProcedure or surgery
The GnRH-a (Diphereline® or Decapetyl®) 0.1mg will be administered for about14 to 20 days for down-regulation. Gonal-f® will be administrated as routinely practiced by investigators. GnRH-a types, GnRH-a and FSH doses will be adjusted according to the clinical experiences of investigators in each site.
| Study group | Role | What they receive |
|---|---|---|
| GnRH-ant protocol | Experimental | Recombinant FSH (Gonal-f®) will be administrated as routinely practiced by investigators. FSH doses will be adjusted according to the clinical experiences of investigators.The GnRH-ant (Cetrotide®) will be initiated in a fixed protocol on stimulation days 5 or 6 per the investigator's ART protocol. Receives: Procedure: GnRH-ant protocol |
| GnRH-a long protocol | Active comparator | The GnRH-a (Diphereline® or Decapetyl®) 0.1mg will be administered for about 14 to 20 days for down-regulation. Gonal-f® will be administrated as routinely practiced by investigators. GnRH-a types, GnRH-a and FSH doses will be adjusted according to the clinical experiences of investigators in each site. Receives: Procedure: GnRH-a long protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
the cumulative live birth rates
To investigate the cumulative live birth rates in infertile women ≤ 38 years old with normal ovarian from one initiated COS cycle.
reserve using GnRH antagonist or agonist protocol for COS in ART treatment Numerator is the No. of women got their first live birth, the Denominator is the No. of women who attempt the ovarian stimulation.
There will be two ways to calculate the CLBR:
- The conservative estimate of the cumulative live birth rate, which is based on the assumption that none of the women who do not return for a subsequent embryo transfer would have had a live birth.
- The optimal estimate of the cumulative live birth rate, which is based on the assumption that women who do not return for a subsequent embryo transfer would have had the same live birth rates as those who do return.
Measured: two years
Secondary outcomes (16)
Number of oocytes retrieved
recorded Number of oocytes retrieved on DOPU
Measured: 24 hours after Oocytes pick up
Good-quality embryo rate (The Istanbul Consensus29)
Total the number of good quality embryos divided by Total the number of embryos
Measured: 24 hours after Oocytes pick up
hCG positive rate
Numerator is the No.of β-hCG blood test which is positive results, he Denominator is the No. of β-hCG blood test. HCG test is Serum β-hCG test after 11 to 17
Measured: after 11 to 17 days of ET
Implantation rate
the number of gestational sacs observed divided by the number of embryos transferred
Measured: 4 to 6 weeks after ET
Clinical pregnancy rate
the number of clinical pregnancies expressed per 100 initiated cycles, aspiration cycles, or embryo transfer cycles. Note: When clinical pregnancy rates are given, the denominator (initiated, aspirated, or embryo transfer cycles) must be specified.
Measured: after 4 to 6 weeks of ET
Ongoing pregnancy rate
the number of . Ongoing pregnancy divided by the number of Clinical pregnancy . Ongoing pregnancy is intrauterine pregnancy continued for 12 gestational weeks (detection of presence of gestational sac with fetal heartbeat by transvaginal ultrasound examination in week 12).
Measured: after 12 weeks of ET
Live birth rate
Numerator is the No. of women got live birth resulting from fresh cycle (multiple births considered as one live birth), the Denominator is the No. of women who attempt the ovarian stimulation.
Measured: two years
Cumulative clinical pregnancy rate
Numerator is the No. of women got their first clinical pregnancy, the Denominator is the No. of women who attempt the ovarian stimulation.
Measured: two years
Miscarriage rate
the number of Miscarriage which is the natural death of an embryo or fetus before it is able to survive independently divided by the number of Clinical pregnancy .
Measured: after 12 weeks of ET
Ectopic pregnancy rate
the number of .extrauterine pregnancy divided by the number of Clinical pregnancy .
Measured: after 4 to 6 weeks of ET
Cycle cancelled rate and reason
Cancelled cycle is an ART cycle in which ovarian stimulation or monitoring has been carried out with the intention to treat, but which did not proceed to follicular aspiration or, in the case of a thawed embryo, to embryo transfer. Cycle cancelled rate is the number of Cancelled cycle divided by the number of embryos transferred.
Measured: On ART cycle
severity of OHSS
Assessed the severity of OHSS.
Measured: two weeks after Oocytes pick up
Rate of OHSS
the number of OHSS divided by the number of ovum pick up. Assessed the severity of OHSS.
Measured: two weeks after Oocytes pick up
Time to pregnancy
time from Gn Initiation to the first clinical pregnancy.
Measured: 4 to 6 weeks after ET
Time to live birth
time from Gn Initiation to the first live birth
Measured: nine months after pregnancy
the Safety
Data on AEs will be collected at scheduled and unscheduled visits, based on information spontaneously provided by the subject and/or through questioning of the subject.
Measured: Two years after signature of informed consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start27 Dec 2018
- Primary completion30 Oct 2021 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SterilityStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Model description
- When patients enter this study, they will be randomly assigned to GnRH-ant group or GnRH-a group at ratio1:1 by the randomization schedule generated by a computer program.
- Masking
- None (open label)
- Enrolment
- 888 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Serono GmbH, Germany, Fountain Medical Development Co., Ltd., Guangzhou KingMed Center for Clinical Lab.Co., Ltd
- Responsible party
- Principal investigator, Jie Qiao, Peking University Third Hospital
- Investigators
- Qiao Jie, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026282
- Sponsor's protocol ID
- MS700623_0020
- Acronym
- CLBR
- Status last verified
- Nov 2019
- First submitted
- 21 Feb 2019
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Study to Investigate the CLBRs of GnRH Antagonist Protocol Compared With the Standard GnRH Agonist Long Protocol for Controlled Ovarian Stimulation in Supposed Normal Ovarian Responders
- ClinicalTrials.gov ID
- NCT04026282
- Acronym / sponsor ID
- CLBR / MS700623_0020
- Conditions
- Sterility
- Keywords
- assisted reproductive technology, live birth, fertilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 888 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Merck Serono GmbH, Germany, Fountain Medical Development Co., Ltd., Guangzhou KingMed Center for Clinical Lab.Co., Ltd
- Study start
- 27 Dec 2018 (actual)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 19 Jul 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.
This is a Phase IV, prospective, randomized controlled study to investigate the cumulative live birth rates (CLBRs) of gonadotrophin-releasing hormone (GnRH) antagonist protocol (GnRH-ant group) compared with the standard GnRH agonist long protocol (GnRH-a group) for controlled ovarian stimulation in supposed normal ovarian responders.
Detailed description
This is a Phase IV, prospective, randomized controlled study to investigate the cumulative live birth rates (CLBRs) of gonadotrophin-releasing hormone (GnRH) antagonist protocol (GnRH-ant group) compared with the standard GnRH agonist long protocol (GnRH-a group) for controlled ovarian stimulation in supposed normal ovarian responders.
In this study, patients who are planning to undergo IVF/ICSI cycle aged ≤38 years old with normal ovarian reserve will be considered for enrollment. Approximately 888 patients will be enrolled at approximately 5 centers in China over a period of 10 months.
About 12-20 visits will be performed in this study for each patient. The CLBR with first live birth resulting from one initiated COS cycle will be compared between GnRH-a group and GnRH-ant group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- When patients enter this study, they will be randomly assigned to GnRH-ant group or GnRH-a group at ratio1:1 by the randomization schedule generated by a computer program.
| Arm | Type | Receives |
|---|---|---|
| GnRH-ant protocol | Experimental | Procedure: GnRH-ant protocolRecombinant FSH (Gonal-f®) will be administrated as routinely practiced by investigators. FSH doses will be adjusted according to the clinical experiences of investigators.The GnRH-ant (Cetrotide®) will be initiated in a fixed protocol on stimulation days 5 or 6 per the investigator's ART protocol. |
| GnRH-a long protocol | Active comparator | Procedure: GnRH-a long protocolThe GnRH-a (Diphereline® or Decapetyl®) 0.1mg will be administered for about 14 to 20 days for down-regulation. Gonal-f® will be administrated as routinely practiced by investigators. GnRH-a types, GnRH-a and FSH doses will be adjusted according to the clinical experiences of investigators in each site. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Infertile women planning to undergo IVF/ICSI cycle using conventional GnRH agonist long protocol or GnRH antagonist protocol
- Age ≤ 38 years old
- Basal AFC 8~20
- Basal FSH≤10 IU/L
- Basal E 2 <200pmol/L
Key exclusion criteria (12 listed)
- Previous IVF/ICSI cycles >2
- Severe hydro-salpinx (Ultrasound shows hydro salpinx﹥2cm)
- Severe endometriosis (Grade III - IV)
- Polycystic ovarian syndrome (PCOS)
- History of recurrent miscarriages (>2 times of miscarriages)
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 |
|---|---|---|
| GnRH-ant protocolRecombinant FSH (Gonal-f®) will be administrated as routinely practiced by investigators. FSH doses will be adjusted according to the clinical experiences of investigators.The GnRH-ant (Cetrotide®) will be initiated in a fixed protocol on stimulation days 5 or 6 per the investigator's ART protocol. | Procedure or surgery | GnRH-ant protocol |
| GnRH-a long protocolThe GnRH-a (Diphereline® or Decapetyl®) 0.1mg will be administered for about14 to 20 days for down-regulation. Gonal-f® will be administrated as routinely practiced by investigators. GnRH-a types, GnRH-a and FSH doses will be adjusted according to the clinical experiences of investigators in each site. | Procedure or surgery | GnRH-a long protocol |
Primary outcome
the cumulative live birth rates
Time frame: two years
To investigate the cumulative live birth rates in infertile women ≤ 38 years old with normal ovarian from one initiated COS cycle. reserve using GnRH antagonist or agonist protocol for COS in ART treatment Numerator is the No. of women got their first live birth, the Denominator is the No. of women who attempt the ovarian stimulation. There will be two ways to calculate the CLBR: * The conservative estimate of the cumulative live birth rate, which is based on the assumption that none of the women who do not return for a subsequent embryo transfer would have had a live birth. * The optimal estimate of the cumulative live birth rate, which is based on the assumption that women who do not return for a subsequent embryo transfer would have had the same live birth rates as those who do return.
16 secondary outcomes
Number of oocytes retrieved
Time frame: 24 hours after Oocytes pick up
Good-quality embryo rate (The Istanbul Consensus29)
Time frame: 24 hours after Oocytes pick up
hCG positive rate
Time frame: after 11 to 17 days of ET
Implantation rate
Time frame: 4 to 6 weeks after ET
Clinical pregnancy rate
Time frame: after 4 to 6 weeks of ET
Ongoing pregnancy rate
Time frame: after 12 weeks of ET
Live birth rate
Time frame: two years
Cumulative clinical pregnancy rate
Time frame: two years
Miscarriage rate
Time frame: after 12 weeks of ET
Ectopic pregnancy rate
Time frame: after 4 to 6 weeks of ET
Cycle cancelled rate and reason
Time frame: On ART cycle
severity of OHSS
Time frame: two weeks after Oocytes pick up
Rate of OHSS
Time frame: two weeks after Oocytes pick up
Time to pregnancy
Time frame: 4 to 6 weeks after ET
Time to live birth
Time frame: nine months after pregnancy
the Safety
Time frame: Two years after signature of informed consent
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
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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.
Qiao Jie principal investigator
Peking University Third Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GnRH-ant protocol and GnRH-a long protocol in people with Sterility, run by Peking University Third Hospital at 4 sites 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 8 inclusion and 12 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 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Contact Qiao Jie (010-82265080, jie.qiao@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the cumulative live birth rates (time frame: two years). 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 8 Nov 2019.