NCT01984320

Brief Summary

The effectiveness of cabergoline to prevent moderate-severe OHSS to coasting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 14, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

August 14, 2017

Status Verified

August 1, 2017

Enrollment Period

1.7 years

First QC Date

October 31, 2013

Last Update Submit

August 11, 2017

Conditions

OHSS

Keywords

OHSSICSICoastingCabergoline

Outcome Measures

Primary Outcomes (1)

  • Rate and degree of OHSS (composite outcome)

    Symptoms of nausea, vomiting, shortness of breath, abdominal pain,abdominal distension. Ovarian size and fluid in douglas pouch by ultrasound. Haematocrit, total leucocytic count, creatinine and Estradiol level as biochemical markers. Early OHSS first 9 days after ovum pickup and late is after 9 days till 14 days (time of pregnancy test)

    14 days

Secondary Outcomes (1)

  • Number of oocytes

    1 day

Other Outcomes (9)

  • Number of Metaphase II (MII) oocytes

    1 day

  • Fertilization rate

    2 days

  • Number of embryos

    3 to 5 days

  • +6 more other outcomes

Study Arms (3)

Coasting

ACTIVE COMPARATOR

In their ICSI cycle patients will continue their agonist treatment while stopping the human menopausal gonadotropin (hMG) injections for 1 to 3 days until drop of estradiol to a safe level to prevent OHSS. Early OHSS is assessed at day of embryo transfer and 7 days after this date. Late OHSS is assessed 14 days after embryo transfer.

Procedure: ICSI

Cabergoline

ACTIVE COMPARATOR

In their ICSI cycle patients will take 0.25 mg of cabergoline daily for 8 days from HCG triggering day to prevent OHSS. Early OHSS is assessed at day of embryo transfer and 7 days after this date. Late OHSS is assessed 14 days after embryo transfer.

Procedure: ICSI

Coasting and Cabergoline

ACTIVE COMPARATOR

In their ICSI cycle patients will continue their agonist treatment while stopping the human menopausal gonadotropin (hMG) injections for 1 day plus receiving 0.25 mg of cabergoline daily for 8 days from HCG triggering day to prevent OHSS. Early OHSS is assessed at day of embryo transfer and 7 days after this date. Late OHSS is assessed 14 days after embryo transfer.

Procedure: ICSI

Interventions

ICSIPROCEDURE

Long luteal GnRH agonist protocol: patients will receive GnRH agonist from day 21 of the previous cycle of stimulation and then on day 3 of the stimulation cycle they will start hMG injections with 225 IU/day. Folliculometry will start on day 6 stimulation by vaginal ultrasound. Estradiol levels will be measured on day 8, 10 and 12 of stimulation if appropriate. According to ultrasound and estradiol level patients will be randomized to either one of the study arms. When ready final triggering will be done by human chorionic gonadotropin (10000 IU) and oocyte collection is done at 36 hour from triggering. Embryo transfer is then done 3 days afterwards with ultrasound guidance.

CabergolineCoastingCoasting and Cabergoline

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age \<or= 35, BMI \<or= 30
  • Long protocol GnRH agonist cycles
  • Estradiol level on day of HCG \>or= 3500 pg/ml
  • Retrieving more than 15 oocytes

You may not qualify if:

  • Male factor
  • Uterine factor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Cairo, Egypt

Location

Related Publications (2)

  • Esinler I, Bozdag G, Karakocsokmensuer L. Preventing ovarian hyperstimulation syndrome: cabergoline versus coasting. Arch Gynecol Obstet. 2013 Nov;288(5):1159-63. doi: 10.1007/s00404-013-2875-z. Epub 2013 May 16.

    PMID: 23677417BACKGROUND

  • Bassiouny YA, Dakhly DMR, Bayoumi YA, Salaheldin NM, Gouda HM, Hassan AA. Randomized trial of combined cabergoline and coasting in preventing ovarian hyperstimulation syndrome during in vitro fertilization/intracytoplasmic sperm injection cycles. Int J Gynaecol Obstet. 2018 Feb;140(2):217-222. doi: 10.1002/ijgo.12360. Epub 2017 Nov 9.

    PMID: 29055130DERIVED

MeSH Terms

Interventions

Sperm Injections, Intracytoplasmic

Intervention Hierarchy (Ancestors)

Fertilization in VitroReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Officials

  • Mohamed Roushdy, MD

    Cairo University

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

October 31, 2013

First Posted

November 14, 2013

Study Start

October 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

August 14, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)