NCT02620605

Brief Summary

Study the effect of early cabergoline administration in prevention of occurrence or decreasing the severity of OHSS in patients undergoing intra cytoplasmic sperm injection.And its effect on oocyte maturation,fertilization and pregnancy rate..

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
75

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2017

Shorter than P25 for phase_3

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
2 years until next milestone

Study Start

First participant enrolled

December 20, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

April 10, 2018

Status Verified

April 1, 2018

Enrollment Period

12 months

First QC Date

November 24, 2015

Last Update Submit

April 8, 2018

Conditions

Ovarian Hyperstimulation Syndrome

Keywords

CabergolineOvarian Hyper Stimulation Syndrome (OHSS)

Outcome Measures

Primary Outcomes (1)

  • Occurrence and severity of OHSS

    either early or late OHSS (early OHSS is the occurrence within 9 days after OPU and occurrence after 10 days was classified as late OHSS.The severity of OHSS was graded according to the criteria of Navot et al. (1992). Moderate OHSS in particular is characterized by abdominal distension and discomfort, nausea±vomiting±diarrhoea, enlarged ovaries 5-12 cm and ultrasonographic evidence of ascites. Severe OHSS is characterized by variable ovarian enlargement; massive ascites±hydrothorax; breathing difficulties; haematocrit \>45%; white blood cell count \>15 000; oligouria; creatinine 1.0-1.5;liver dysfunction; and anasarca oedema.)

    2 to 4weeks after trigger

Secondary Outcomes (4)

  • Number of M|| oocytes.

    maximum one day after ovum pick up

  • Fertilization rate.

    16 to 19 hours after ICSI

  • Clinical Pregnancy rate

    2 to 4 weeks after positive pregnancy test

  • implantation rate

    2 to 4 weeks after positive pregnancy test

Study Arms (2)

Late administration of Cabirgoline 0.5 mg

ACTIVE COMPARATOR

Cabergoline 0.5mg (Dostinex®, Pfizer Australia Pty Ltd ) administrated once daily started on day of HCG triggering and continued for 8 days.

Drug: Late Cabergoline 0.5mg

Early administration of Cabirgoline 0.5mg

EXPERIMENTAL

Cabergoline 0.5mg(Dostinex®, Pfizer Australia Pty Ltd ) once daily stared once patients fulfilling the inclusion criteria at any day of cycle and continued for 8 days post HCG trigger.

Drug: Early Cabergoline 0.5mg

Interventions

Late Cabergoline 0.5mgDRUG

Cabergoline 0.5mg will be administrated once daily at day of HCG trigger and continued for 8days

Also known as: Dostenix (Dostinex®, Pfizer Australia Pty Ltd )
Late administration of Cabirgoline 0.5 mg
Early Cabergoline 0.5mgDRUG

Cabergoline 0.5mg will be administrated once daily when E2 is more than 4000pg/ml and /or more than 18 follicles of 11mm diameter or more are encountered at any day of the controlled ovarian hyper-stimulation and before HCG trigger to be continued for 8days after HCG trigger.

Also known as: Dostinex (Dostinex®, Pfizer Australia Pty Ltd )
Early administration of Cabirgoline 0.5mg

Eligibility Criteria

Age19 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female less than 35 years under going Intra cytoplasmic sperm injection cycle for infertility (tubal factor or un explained infertility).
  • or more oocyte 11 mm in diameter and/or E2 is more than 4000 pg/ml at any day of the stimulation cycle before or at HCG trigger

You may not qualify if:

  • patient with one ovary
  • patients already receiving cabergoline treatment
  • Severe Male factor infertility.
  • Thyroid dysfunction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVF department in Kasr Alaini hospital,private IVF centre

Cairo, 1325, Egypt

RECRUITING

MeSH Terms

Conditions

Ovarian Hyperstimulation Syndrome

Interventions

Cabergoline

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ErgolinesErgot AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-Ring

Study Officials

  • Mona M Shaban, MD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherine H Gad Allah, MD

CONTACT

01097665573sherinehosny@gmail.com

mona M Shaban, MD

CONTACT

01001078586monashaban75@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Mona Mohamed shaban ,assistant professor MD

Study Record Dates

First Submitted

November 24, 2015

First Posted

December 3, 2015

Study Start

December 20, 2017

Primary Completion

December 1, 2018

Study Completion

April 1, 2019

Last Updated

April 10, 2018

Record last verified: 2018-04

Locations

EG(1)