NCT04265495

Brief Summary

a comparative study among dual trigger, urinary HCG and recombinant HCG regarding the outcome of ICSI- antagonist cycles

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
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

February 9, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

1.8 years

First QC Date

February 9, 2020

Last Update Submit

September 27, 2021

Conditions

IVF

Keywords

Dual trigger implantation,HCGOHSSANTAGONIST

Outcome Measures

Primary Outcomes (3)

  • clinical pregnancy rate,

    4 WEEKS

  • implantation rate,

    2 WEEKS

  • incidence of OHSS.

    1 WEEK

Study Arms (3)

DUAL TRIGGERING

PATIENTS WILL RECEIVE DUAL TRIGGERING

URINARY HCG

PATIENTS WILL RECEIVE URINARY HCG

RECOMBINANT HCG

PATIENTS WILL RECEIVE RECOMBINANT HCG

Eligibility Criteria

Age22 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

patients \<40 years of age who underwent IVF/ICSI cycles using a GnRH antagonist protocol, then at the time of triggering, we divided the patients to 3 groups by for triggering by a dual trigger, urinary HCG and recombinant HCG and then will check the outcome regarding the maturity and oocyte quality, implantation rate, clinical pregnancy rate as well as incidence of OHSS

You may qualify if:

  • patients \<40 years of age who underwent IVF/ICSI cycles using a GnRH antagonist protocol

You may not qualify if:

  • age: \> 40 years
  • BMI \> 30 ,
  • long agonist protocol
  • were chromosomal and genetic disorders, abnormal ultrasonogram of the uterine cavity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-BARAKA FERTILITY HOSPITAL

Manama, Adliya, 15006, Bahrain

RECRUITING

Central Study Contacts

Kamal eldin Rageh, M.D.

CONTACT

0097333153871dr_kamal_rageh@yahoo.com

Ahmed Barakat, FRCOG

CONTACT

0097317727888ahmed.barakat@yahoo.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DOCTOR

Study Record Dates

First Submitted

February 9, 2020

First Posted

February 11, 2020

Study Start

February 9, 2020

Primary Completion

November 30, 2021

Study Completion

December 1, 2021

Last Updated

September 28, 2021

Record last verified: 2021-09

Locations

BA(1)