NCT02306564

Brief Summary

The purpose of this study is to determine the effect of giving cabergoline to patients at risk of OHSS (ovarian hyperstimulation syndrome) after ovum pick up, on endometrial vascularity and it's effect on pregnancy outcome

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
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2014

Typical duration for phase_2

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

December 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 6, 2016

Status Verified

December 1, 2016

Enrollment Period

2.9 years

First QC Date

December 1, 2014

Last Update Submit

December 3, 2016

Conditions

Infertility

Keywords

ICSIcabergolineSubendometrial vascularity

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rate (chemical , clinical).

    beta human chorionic gonadotrophin (βHCG) \>10 IU on day 12 after embryo transfer

    2 weeks after embryo transfer

Secondary Outcomes (9)

  • Miscarriage rate

    3 weeks after positive βHCG

  • OHSS rate

    4 weeks

  • Vascularization index (VI)

    5 days

  • Flow index (FI)

    5 days

  • vascularization flow index (VFI)

    5 days

  • +4 more secondary outcomes

Study Arms (3)

Group A

EXPERIMENTAL

Group A will include patients at risk of OHSS receiving Cabergoline 0.5mg daily for 8 days (Dostinex®, Pfizer Australia Pty Ltd ) from the day of oocyte pick up for prevention of hyperstimulation

Drug: Cabergoline

Group B

NO INTERVENTION

Group B will include patients AT RISK of ovarian hyperstimulation syndrome (OHSS) not receiving Cabergoline.

Group C

NO INTERVENTION

Group C will serve as a control group and will include age \& BMI matched patients NOT AT RISK of OHSS, and not receiving cabergoline.

Interventions

CabergolineDRUG

given to patients at high risk for OHSS

Also known as: dostinex
Group A

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age ≥18 - ≤40 years
  • Normal serum prolactin level.
  • Tubal factor of infertility.
  • Unexplained infertility.
  • BMI ≥ 30 kg/m2.
  • Estradiol (E2)\>3,500 pg/ml on day of ovulation trigger.
  • Patients who underwent coasting for OHSS prevention.
  • More than 20 follicles ≥11 mm on the day of final oocyte maturation.

You may not qualify if:

  • Contraindication of pregnancy e.g.: Somatic and mental diseases, which are contraindications for carrying of a pregnancy and childbirth, inborn malformations or acquired deformations of uterus cavity which make embryo implantation or carrying of a pregnancy impossible ,ovarian tumors.
  • Severe Male factor infertility.
  • Hyperprolactinemic patients.
  • Frozen embryo transfer cycles
  • Uterine Anomalies.
  • Uterine synechia.
  • History of Genital Tuberculosis.
  • Repeated implantation failure in ICSI.
  • On medication that is known to alter prolactin levels e.g antipsychotics, Atypical agents and risperidone
  • Thyroid dysfunction.
  • Medical disorders affecting serum prolactin eg acromegaly ,chronic renal failure and hypothyroidism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assissted reproduction unit Kasr alaini hospital

Ḩadā’iq al Qubbah, Cairo Governorate, 11562, Egypt

RECRUITING

Related Publications (1)

  • Tang H, Mourad SM, Wang A, Zhai SD, Hart RJ. Dopamine agonists for preventing ovarian hyperstimulation syndrome. Cochrane Database Syst Rev. 2021 Apr 14;4(4):CD008605. doi: 10.1002/14651858.CD008605.pub4.

    PMID: 33851429DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Cabergoline

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Ahmed M Kamel, MD

    Lecturer of obstetrics & Gynecology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed M Kamel, MD

CONTACT

00201120022332Dr.ahmed.m.kamel@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Obstetric & Gynecology

Study Record Dates

First Submitted

December 1, 2014

First Posted

December 3, 2014

Study Start

December 1, 2014

Primary Completion

November 1, 2017

Study Completion

December 1, 2017

Last Updated

December 6, 2016

Record last verified: 2016-12

Locations

EG(1)