Status:
UNKNOWN
To Investigate the Cumulative Live Birth Rates Using GnRH Antagonist or Agonist Protocol for COS in ART Treatment
Lead Sponsor:
Peking University Third Hospital
Collaborating Sponsors:
Merck Serono GmbH, Germany
Fountain Medical Development Co., Ltd.
Conditions:
Sterility
Eligibility:
FEMALE
18-38 years
Phase:
NA
Brief 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) compa...
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) compa...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
December 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2022
Estimated Enrollment :
888 Patients enrolled
Trial Details
Trial ID
NCT04026282
Start Date
December 27 2018
End Date
July 31 2022
Last Update
November 8 2019
Active Locations (4)
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1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100000
2
The second hospital of Hebei Medical University
Baoding, Hebei, China, 300000
3
The third hospital of Zhengzhoui Medical University
Zhengzhou, Henan, China, 450000
4
Jiangsu Provincial Hospital
Nanjing, Zhejiang, China, 210000