NCT02397642

Brief Summary

To salvage the luteal phase and improve pregnancy rate in antagonist IVF/ICSI cycles triggered with GnRH agonist. Two strategies are compared dual trigger with GnRH agonist plus 1000 IU of HCG or triggering with GnRH and giving a booster dose of HCG (1500 IU) on the day of ovum pickup.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

March 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 25, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

January 29, 2018

Status Verified

January 1, 2018

Enrollment Period

2.8 years

First QC Date

March 16, 2015

Last Update Submit

January 25, 2018

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    The number of cycles with a evidence of a gestational sac with fetal pulstaions after 5 weeks from pregnancy test

    1 year

Secondary Outcomes (1)

  • OHSS rate

    1 year

Other Outcomes (4)

  • Chemical pregnancy rate

    1 year

  • Early miscarriage rate

    1 year

  • Ongoing pregnancy rate

    1 year

  • +1 more other outcomes

Study Arms (2)

Dual trigger

ACTIVE COMPARATOR

GnRH agonist plus 1000 IU of HCG to trigger final maturation

Procedure: IVF/ICSIDrug: Human Chorionic Gonadotropin

Booster HCG dose

ACTIVE COMPARATOR

GnRH agonist only to trigger final maturation followed by a booster dose of 1500 IU of HCG on the day of ovum pickup

Procedure: IVF/ICSIDrug: Human Chorionic Gonadotropin

Interventions

IVF/ICSIPROCEDURE
Booster HCG doseDual trigger
Human Chorionic GonadotropinDRUG

given in different doses and timing to support the luteal phase

Booster HCG doseDual trigger

Eligibility Criteria

Age20 Years - 37 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • High responder females undergoing antagonist protocol IVF/ICSI cycle
  • More than 14 MII oocytes
  • Estradiol more than 3500 pg/ml on day of trigger

You may not qualify if:

  • Any other protocol
  • Normal or poor responders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)

Cairo, Egypt

Location

Adam International hospital

Giza, Egypt

Location

Nile IVF center

Giza, Egypt

Location

MeSH Terms

Conditions

Infertility

Interventions

Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

GonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPlacental HormonesPeptidesAmino Acids, Peptides, and ProteinsPregnancy ProteinsProteins

Study Officials

  • Sarwat Ahwany, MD

    Cairo University

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

March 16, 2015

First Posted

March 25, 2015

Study Start

March 1, 2015

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

January 29, 2018

Record last verified: 2018-01

Locations

EG(3)