NCT04026282

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) compared with the standard GnRH agonist long protocol (GnRH-a group) for controlled ovarian stimulation in supposed normal ovarian responders.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
888

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 27, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 19, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

November 8, 2019

Status Verified

November 1, 2019

Enrollment Period

2.8 years

First QC Date

February 21, 2019

Last Update Submit

November 6, 2019

Conditions

Sterility

Keywords

assisted reproductive technologylive birthfertilization

Outcome Measures

Primary Outcomes (1)

  • 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.

    two years

Secondary Outcomes (16)

  • Number of oocytes retrieved

    24 hours after Oocytes pick up

  • Good-quality embryo rate (The Istanbul Consensus29)

    24 hours after Oocytes pick up

  • hCG positive rate

    after 11 to 17 days of ET

  • Implantation rate

    4 to 6 weeks after ET

  • Clinical pregnancy rate

    after 4 to 6 weeks of ET

  • +11 more secondary outcomes

Study Arms (2)

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.

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.

Procedure: GnRH-a long protocol

Interventions

GnRH-ant protocolPROCEDURE

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
GnRH-a long protocolPROCEDURE

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.

GnRH-a long protocol

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsInfertile women planning to undergo IVF/ICSI cycle aged ≤38 years old with normal ovarian reserve
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Peking University Third Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

The second hospital of Hebei Medical University

Baoding, Hebei, 300000, China

RECRUITING

The third hospital of Zhengzhoui Medical University

Zhengzhou, Henan, 450000, China

RECRUITING

Jiangsu Provincial Hospital

Nanjing, Zhejiang, 210000, China

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Qiao Jie

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiao Jie

CONTACT

010-82265080jie.qiao@263.net

Rui Yang

CONTACT

13810002416yrjeff@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 21, 2019

First Posted

July 19, 2019

Study Start

December 27, 2018

Primary Completion

October 30, 2021

Study Completion

July 31, 2022

Last Updated

November 8, 2019

Record last verified: 2019-11

Locations

CN(4)