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Trial · Interventional

CompletedPhase 4Registry data

Antagonist Protocol in Poor Responders

NCTNCT02195947 (opens ClinicalTrials.gov in a new tab)Other id72014
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Overview

Status
Completed
Phase
Phase 4
Enrollment
141 participants (actual)
Sponsor
Cairo University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Egypt

Start
Jul 2014
Primary completion
Jul 2015
Completion
Jul 2015
First posted
21 Jul 2014 (estimated)
Last update posted
11 Nov 2021
Conditions
Female Infertility Due to Diminished Ovarian Reserve

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420152016
  1. Ph 4

    Antagonist Protocol in Poor Responders

    NCT02195947

    Jul 2014 to Jul 2015

Registry summary

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

The effect of use of the growth hormone with antagonist protocol on the outcome of the IVF/ICSI cycles in poor responders.

Interventions

  • Growth HormoneDrug

Arms2

  • Experimental

    Antagonist and Growth hormone

    HMG IM daily was administrated from day 2 of the cycle. The GnRH antagonist (Cetrotide, Serono, Geneva, Switzerland) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC. Growth hormone (Norditropin, Novo nordisk) was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration.

  • No intervention

    Antagonist

    HMG IM daily was administrated from day 2 of the cycle. The GnRH antagonist (Cetrotide, Serono, Geneva, Switzerland) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Live birth rate

    Time frame · Up to 9 months

Secondary outcomes(1)

  1. Clinical pregnancy rate

    Time frame · Up to 5 weeks

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.

  • DerivedBassiouny YA, Dakhly DMR, Bayoumi YA, Hashish NM. Does the addition of growth hormone to the in vitro fertilization/intracytoplasmic sperm injection antagonist protocol improve outcomes in poor responders? A randomized, controlled trial. Fertil Steril. 2016 Mar;105(3):697-702. doi: 10.1016/j.fertnstert.2015.11.026. Epub 2015 Dec 13. PMID 26690008

Eligibility

Who could join, as posted.

Sex
Female
Age
from 20 Years up to 45 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * females fulfilling the criteria of the ESHRE consensus 2011: * at least two of the following three features must be present: * dvanced maternal age (≥40 years) or any other risk factor for POR * previous POR (≤3 oocytes with a conventional stimulation protocol) * an abnormal ovarian reserve test (i.e. AFC ,5-7 follicles or AMH ,0.5 -1.1 ng/ml). Exclusion Criteria: * women who suffer from any other cause of infertility other than poor ovarian reserve * refusal of the patient to consent for using her data in the study.

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