Growth Hormone Co-treatment Within a GnRH Antagonist Protocol in Patients With Poor Ovarian Response
Sponsor
Riyadh Fertility and Reproductive Health center (Other)
Overall Status
Unknown status
CT.gov ID
NCT03373149
Collaborator
(none)
228
1
2
35.1
6.5
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
228 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Growth Hormone Co-treatment Within a GnRH Antagonist Protocol in Patients With Poor Ovarian Response
Actual Study Start Date
:
Nov 29, 2017
Anticipated Primary Completion Date
:
Jul 1, 2020
Anticipated Study Completion Date
:
Nov 1, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Growth hormone/HPuFSH/GnRH antagonist The patients receive growth hormone |
Drug: 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.
|
| Active Comparator: HPuFSH/GnRH antagonist Growth hormone is not used |
Drug: 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.
|
Outcome Measures
Primary Outcome Measures
- The number of participants who achieved a clinical pregnancy in a transfer cycle [Five weeks after embryo transfer]
Secondary Outcome Measures
- The number of participants who achieved a ongoing pregnancy in a transfer cycle [Eighteen weeks after embryo transfer]
Eligibility Criteria
Criteria
Ages Eligible for Study:
35 Years
to 42 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Serum anti-Müllerian hormone (AMH) less than 1.2 ng/ml
Exclusion Criteria:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Riyadh Fertility and Reproductive Health center | Giza | Egypt |
Sponsors and Collaborators
- Riyadh Fertility and Reproductive Health center
Investigators
- Study Chair: Hisham S Elshaer, Prof., Prof. of Obstetrics and Gynecology,Faculty of medicine, Cairo university. Director of Riyadh Fertility and Reproductive Health center
- Study Director: Usama M Fouda, Prof., Prof. of Obstetrics and Gynecology,Faculty of medicine, Cairo university. Consultant at Riyadh Fertility and Reproductive Health center
- Principal Investigator: Mohammad Taymour, M.D, PhD, Lecturer of Obstetrics and Gynecology, Faculty of medicine,Cairo university. Consultant at Riyadh Fertility and Reproductive Health center
- Principal Investigator: Ahmed A Wali, M.D, PhD, Lecturer of Obstetrics and Gynecology,Faculty of medicine, Cairo university. Consultant at Riyadh Fertility and Reproductive Health center
- Principal Investigator: Fatma Faisel, M.D, PhD, Lecturer of Obstetrics and Gynecology,Faculty of medicine, Cairo university. Consultant at Riyadh Fertility and Reproductive Health center
Study Documents (Full-Text)
None provided.More Information
Publications
Responsible Party:
Riyadh Fertility and Reproductive Health center
ClinicalTrials.gov Identifier:
NCT03373149
Other Study ID Numbers:
- Gh/poor responders
First Posted:
Dec 14, 2017
Last Update Posted:
May 27, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Riyadh Fertility and Reproductive Health center
Additional relevant MeSH terms: