Growth Hormone Co-treatment Within a GnRH Antagonist Protocol in Patients With Poor Ovarian Response
NCT ID: NCT03373149
Last Updated: 2020-05-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
228 participants
INTERVENTIONAL
2017-11-29
2020-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Growth Hormone (GH) in in Vitro Fertilization (IVF) Poor-responder Patients
NCT01298960
Efficacy of Growth Hormone Supplementation With Gonadotrophins in IVF/ICSI for Poor Responders
NCT03759301
Ultrashort GnRH Agonist/Antagonist Versus GnRH Antagonist IVF
NCT02173977
Antagonist Protocol in Poor Responders
NCT02195947
Corifollitropin Alfa Followed by hpHMG in a Long GnRH Agonist Protocol for the Treatment of Poor Ovarian Responders
NCT01732094
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Growth hormone/HPuFSH/GnRH antagonist
The patients receive growth hormone
Growth hormone/HPuFSH/GnRH antagonist
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.
HPuFSH/GnRH antagonist
Growth hormone is not used
HPuFSH/GnRH antagonist
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Growth hormone/HPuFSH/GnRH antagonist
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.
HPuFSH/GnRH antagonist
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
35 Years
42 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Riyadh Fertility and Reproductive Health center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hisham S Elshaer, Prof.
Role: STUDY_CHAIR
Prof. of Obstetrics and Gynecology,Faculty of medicine, Cairo university. Director of Riyadh Fertility and Reproductive Health center
Usama M Fouda, Prof.
Role: STUDY_DIRECTOR
Prof. of Obstetrics and Gynecology,Faculty of medicine, Cairo university. Consultant at Riyadh Fertility and Reproductive Health center
Mohammad Taymour, M.D, PhD
Role: PRINCIPAL_INVESTIGATOR
Lecturer of Obstetrics and Gynecology, Faculty of medicine,Cairo university. Consultant at Riyadh Fertility and Reproductive Health center
Ahmed A Wali, M.D, PhD
Role: PRINCIPAL_INVESTIGATOR
Lecturer of Obstetrics and Gynecology,Faculty of medicine, Cairo university. Consultant at Riyadh Fertility and Reproductive Health center
Fatma Faisel, M.D, PhD
Role: PRINCIPAL_INVESTIGATOR
Lecturer of Obstetrics and Gynecology,Faculty of medicine, Cairo university. Consultant at Riyadh Fertility and Reproductive Health center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Riyadh Fertility and Reproductive Health center
Giza, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Gh/poor responders
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.