To Investigate the Cumulative Live Birth Rates Using GnRH Antagonist or Agonist Protocol for COS in ART Treatment
NCT ID: NCT04026282
Last Updated: 2019-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
888 participants
INTERVENTIONAL
2018-12-27
2022-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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GnRH-ant protocol
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-ant protocol
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 protocol
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.
GnRH-a long protocol
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.
Interventions
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GnRH-ant protocol
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 protocol
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
38 Years
FEMALE
No
Sponsors
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Merck Serono GmbH, Germany
INDUSTRY
Fountain Medical Development Co., Ltd.
INDUSTRY
Guangzhou KingMed Center for Clinical Lab.Co., Ltd
UNKNOWN
Peking University Third Hospital
OTHER
Responsible Party
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Jie Qiao
Professor
Principal Investigators
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Qiao Jie
Role: PRINCIPAL_INVESTIGATOR
Peking University Third Hospital
Locations
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Peking University Third Hospital
Beijing, Beijing Municipality, China
The second hospital of Hebei Medical University
Baoding, Hebei, China
The third hospital of Zhengzhoui Medical University
Zhengzhou, Henan, China
Jiangsu Provincial Hospital
Nanjing, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Jiamin Hao
Role: primary
Xingling Wang
Role: primary
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MS700623_0020
Identifier Type: -
Identifier Source: org_study_id
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