Back to resultsAntagonist Protocol in Poor Responders
Primary Purpose
Female Infertility Due to Diminished Ovarian Reserve
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Growth Hormone
Sponsored by
About this trial
This is an interventional treatment trial for Female Infertility Due to Diminished Ovarian Reserve focused on measuring Growth hormone, IVF/ICSI, Poor responder, Antagonist protocol
Eligibility 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.
Sites / Locations
- Kasr Al Aini
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Antagonist and Growth hormone
Antagonist
Arm Description
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.
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
Outcomes
Primary Outcome Measures
Live birth rate
Secondary Outcome Measures
Clinical pregnancy rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02195947
Brief Title
Antagonist Protocol in Poor Responders
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 Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The effect of use of the growth hormone with antagonist protocol on the outcome of the IVF/ICSI cycles in poor responders.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Infertility Due to Diminished Ovarian Reserve
Keywords
Growth hormone, IVF/ICSI, Poor responder, Antagonist protocol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
141 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Antagonist and Growth hormone
Arm Type
Experimental
Arm Description
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.
Arm Title
Antagonist
Arm Type
No Intervention
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Growth Hormone
Other Intervention Name(s)
Norditropin, Novo nordisk
Intervention Description
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.
Primary Outcome Measure Information:
Title
Live birth rate
Time Frame
Up to 9 months
Secondary Outcome Measure Information:
Title
Clinical pregnancy rate
Time Frame
Up to 5 weeks
Other Pre-specified Outcome Measures:
Title
Chemical pregnancy rate
Time Frame
5 weeks
Title
Early miscarriage rate
Time Frame
Up to 12 weeks
Title
Ongoing pregnancy rate
Time Frame
Up to 12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yomna A Bayoumi, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Al Aini
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
26690008
Citation
Bassiouny 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.
Results Reference
derived
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Antagonist Protocol in Poor Responders
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