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Trial record 10 of 613 for:    "Growth Hormone"

Antagonist Protocol in Poor Responders

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ClinicalTrials.gov Identifier: NCT02195947
Recruitment Status : Completed
First Posted : July 21, 2014
Last Update Posted : August 11, 2015
Sponsor:
Information provided by (Responsible Party):
Yasmin Ahmed Bassiouny, Cairo University

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

Condition or disease Intervention/treatment Phase
Female Infertility Due to Diminished Ovarian Reserve Drug: Growth Hormone Phase 4

Detailed Description:
Two groups of poor responder female patients planned to receive the antagonist IVF/ICSI protocol are randomized to whether or not to add growth hormone to their protocol.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does the Addition of Growth Hormone to the Invitro Fertilization/ Intracytoplasmic Sperm Injection Antagonist Protocol Improve Outcome in Poor Responders? A Randomized Controlled Trial
Study Start Date : July 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
Drug Information available for: Somatropin
U.S. FDA Resources

Arm Intervention/treatment
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.
Drug: Growth Hormone
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.
Other Name: Norditropin, Novo nordisk
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 Outcome Measures :
  1. Live birth rate [ Time Frame: Up to 9 months ]

Secondary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: Up to 5 weeks ]

Other Outcome Measures:
  1. Chemical pregnancy rate [ Time Frame: 5 weeks ]
  2. Early miscarriage rate [ Time Frame: Up to 12 weeks ]
  3. Ongoing pregnancy rate [ Time Frame: Up to 12 weeks ]


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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02195947


Locations
Egypt
Kasr Al Aini
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
Principal Investigator: Yomna A Bayoumi, MD Cairo University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yasmin Ahmed Bassiouny, Dr, Cairo University
ClinicalTrials.gov Identifier: NCT02195947     History of Changes
Other Study ID Numbers: 72014
First Posted: July 21, 2014    Key Record Dates
Last Update Posted: August 11, 2015
Last Verified: August 2015

Keywords provided by Yasmin Ahmed Bassiouny, Cairo University:
Growth hormone
IVF/ICSI
Poor responder
Antagonist protocol

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs