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Trial · Interventional

CompletedPhase 4Registry data

Coasting Versus Antagonist Protocol in Patients at High Risk of OHSS

NCTNCT03996434 (opens ClinicalTrials.gov in a new tab)Other idClin-I-0201907
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Overview

Status
Completed
Phase
Phase 4
Enrollment
300 participants (actual)
Sponsor
ClinAmygate · Other
Design
Randomized · Double masking
Countries
1 country

Egypt

Start
1 Jul 2019
Primary completion
10 Nov 2019
Completion
20 Nov 2019
First posted
24 Jun 2019
Last update posted
21 Nov 2019
Conditions
Ovarian Hyperstimulation Syndrome

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20192020
  1. Ph 4

    Coasting Versus Antagonist Protocol in Patients at High Risk of OHSS

    NCT03996434

    1 Jul 2019 to 20 Nov 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The aim of this work is to study the value of GnRH antagonist subcutaneous administration as an alternative to coasting in prevention of severe OHSS and its impact on embryos quality \& the outcome of ICSI.

Interventions

  • GonadotropinDrug
  • AntagonistDrug

Arms2

  • Experimental

    Coasting group

    Including 150 patients who will undergo withholding gonadotropin administration for at least 24 hours before triggering ovulation with hCG. GnRH agonist will be continued daily till the day of triggering. E2 will be measured daily until the concentration falls to ≤ 3000 pg/ml, then 5000 IU of hCG will be given.

  • Active comparator

    Antagonist group

    Including 150 patients who will receive GnRH antagonist (subcutaneous injection Cetrorelix acetate 0.25 mg (Cetrotide, Serono, UK)) daily until the day of hCG administration. GnRH agonist will be discontinued at the start of antagonist administration. E2 will be measured daily until the concentration falls to ≤ 3000 pg/ml and TVS revealed that follicles diameter is ≥ 18 mm, then 5000 IU of hCG will be given.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of high quality embryos

    Time frame · Within 48 hours of fertilization

    Registry description

    Number of high quality embryos

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultAboulghar MA, Mansour RT, Amin YM, Al-Inany HG, Aboulghar MM, Serour GI. A prospective randomized study comparing coasting with GnRH antagonist administration in patients at risk for severe OHSS. Reprod Biomed Online. 2007 Sep;15(3):271-9. doi: 10.1016/s1472-6483(10)60339-2. PMID 17854523

Eligibility

Who could join, as posted.

Sex
Female
Age
from 20 Years up to 40 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * infertile women * age 20-40 * at high risk for OHSS Exclusion Criteria: * refuse to participate

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