Back to resultsGrowth Hormone Co-treatment Within a GnRH Antagonist Protocol in Patients With Poor Ovarian Response
Primary Purpose
Infertility, Female
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Growth hormone/HPuFSH/GnRH antagonist
HPuFSH/GnRH antagonist
Sponsored by
About this trial
This is an interventional treatment trial for Infertility, Female focused on measuring IVF, Growth hormone, Poor responders
Eligibility Criteria
Inclusion Criteria:
- Serum anti-Müllerian hormone (AMH) less than 1.2 ng/ml
Exclusion Criteria:
-
Sites / Locations
- Riyadh Fertility and Reproductive Health centerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Growth hormone/HPuFSH/GnRH antagonist
HPuFSH/GnRH antagonist
Arm Description
The patients receive growth hormone
Growth hormone is not used
Outcomes
Primary Outcome Measures
The number of participants who achieved a clinical pregnancy in a transfer cycle
Secondary Outcome Measures
The number of participants who achieved a ongoing pregnancy in a transfer cycle
Full Information
NCT ID
NCT03373149
First Posted
December 7, 2017
Last Updated
May 24, 2020
Sponsor
Riyadh Fertility and Reproductive Health center
1. Study Identification
Unique Protocol Identification Number
NCT03373149
Brief Title
Growth Hormone Co-treatment Within a GnRH Antagonist Protocol in Patients With Poor Ovarian Response
Official Title
Growth Hormone Co-treatment Within a GnRH Antagonist Protocol in Patients With Poor Ovarian Response
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 29, 2017 (Actual)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
November 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riyadh Fertility and Reproductive Health center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this study, the investigators will assess the efficacy of growth hormone co-stimulation to GnRH antagonist regimen in poor responders to COH for IVF.
Detailed Description
To date, a limited number of studies have been performed in order to assess whether the addition of GH can improve the probability of pregnancy in poor responders undergoing ovarian stimulation for IVF. Moreover, the existing studies are underpowered and, thus, inconclusive.
In this study, the investigators will assess the efficacy of growth hormone co-stimulation to GnRH antagonist regimen in poor responders to COH for IVF.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
Keywords
IVF, Growth hormone, Poor responders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
228 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Growth hormone/HPuFSH/GnRH antagonist
Arm Type
Experimental
Arm Description
The patients receive growth hormone
Arm Title
HPuFSH/GnRH antagonist
Arm Type
Active Comparator
Arm Description
Growth hormone is not used
Intervention Type
Drug
Intervention Name(s)
Growth hormone/HPuFSH/GnRH antagonist
Intervention Description
Growth hormone (Somatropin, Sedico, Egypt) [4 IU/day] and highly purified urinary FSH (HPuFSH) (Fostimon,IBSA, Switzerland) [300 IU/day] will be started on cycle day 3 and will be continued until and including the day of human chorionic gonadotropin (HCG) administration. Starting from cycle day 8, the dose of HPuFSH will be adjusted individually according to ovarian response which will be monitored using transvaginal ultrasound and serum estradiol (E2).
GnRH antagonist (Cetrorelix acetate) (Cetrotide; Serono International S.A., Geneva, Switzerland) 0.25 mg S.C. once daily will be started when the leading follicle is 14 mm in mean diameter and will be continued until and including the day of HCG administration.
Intervention Type
Drug
Intervention Name(s)
HPuFSH/GnRH antagonist
Intervention Description
Highly purified urinary FSH (HPuFSH) (Fostimon,IBSA, Switzerland) [300 IU/day] will be started on cycle day 3 and will be continued until and including the day of human chorionic gonadotropin (HCG) administration. Starting from cycle day 8, the dose of HPuFSH will be adjusted individually according to ovarian response which will be monitored using transvaginal ultrasound and serum estradiol (E2).
GnRH antagonist (Cetrorelix acetate) (Cetrotide; Serono International S.A., Geneva, Switzerland) 0.25 mg S.C. once daily will be started when the leading follicle is 14 mm in mean diameter and will be continued until and including the day of HCG administration.
Primary Outcome Measure Information:
Title
The number of participants who achieved a clinical pregnancy in a transfer cycle
Time Frame
Five weeks after embryo transfer
Secondary Outcome Measure Information:
Title
The number of participants who achieved a ongoing pregnancy in a transfer cycle
Time Frame
Eighteen weeks after embryo transfer
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Serum anti-Müllerian hormone (AMH) less than 1.2 ng/ml
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Usama M Fouda, Prof.
Phone
+201095401375
Email
umfrfouda@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hisham S Elshaer, Prof.
Organizational Affiliation
Prof. of Obstetrics and Gynecology,Faculty of medicine, Cairo university. Director of Riyadh Fertility and Reproductive Health center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Usama M Fouda, Prof.
Organizational Affiliation
Prof. of Obstetrics and Gynecology,Faculty of medicine, Cairo university. Consultant at Riyadh Fertility and Reproductive Health center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohammad Taymour, M.D, PhD
Organizational Affiliation
Lecturer of Obstetrics and Gynecology, Faculty of medicine,Cairo university. Consultant at Riyadh Fertility and Reproductive Health center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmed A Wali, M.D, PhD
Organizational Affiliation
Lecturer of Obstetrics and Gynecology,Faculty of medicine, Cairo university. Consultant at Riyadh Fertility and Reproductive Health center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fatma Faisel, M.D, PhD
Organizational Affiliation
Lecturer of Obstetrics and Gynecology,Faculty of medicine, Cairo university. Consultant at Riyadh Fertility and Reproductive Health center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riyadh Fertility and Reproductive Health center
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Usama M Fouda, Prof.
Phone
+201095401375
Email
umfrfouda@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23208461
Citation
Eftekhar M, Aflatoonian A, Mohammadian F, Eftekhar T. Adjuvant growth hormone therapy in antagonist protocol in poor responders undergoing assisted reproductive technology. Arch Gynecol Obstet. 2013 May;287(5):1017-21. doi: 10.1007/s00404-012-2655-1. Epub 2012 Dec 4.
Results Reference
background
PubMed Identifier
34808697
Citation
Sood A, Mohiyiddeen G, Ahmad G, Fitzgerald C, Watson A, Mohiyiddeen L. Growth hormone for in vitro fertilisation (IVF). Cochrane Database Syst Rev. 2021 Nov 22;11(11):CD000099. doi: 10.1002/14651858.CD000099.pub4.
Results Reference
derived
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Growth Hormone Co-treatment Within a GnRH Antagonist Protocol in Patients With Poor Ovarian Response
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