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To Investigate the Cumulative Live Birth Rates Using GnRH Antagonist or Agonist Protocol for COS in ART Treatment

NCT04026282 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 888

Last updated 2019-11-08

No results posted yet for this study

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 ovarian responders.

Conditions

  • Sterility

Interventions

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Merck Serono GmbH, Germany

    collaborator INDUSTRY

  • Fountain Medical Development Co., Ltd.

    collaborator INDUSTRY

  • Guangzhou KingMed Center for Clinical Lab.Co., Ltd

    collaborator UNKNOWN

  • Peking University Third Hospital

    lead OTHER

Principal Investigators

  • Qiao Jie · Peking University Third Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
38 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-27
Primary Completion
2021-10-30
Completion
2022-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04026282 on ClinicalTrials.gov