Infertility, FemalePhase 2NCT03373149
Growth Hormone Co-treatment Within a GnRH Antagonist Protocol in Patients With Poor Ovarian Response
A Phase 2 study testing Growth hormone/HPuFSH/GnRH antagonist and HPuFSH/GnRH antagonist in people with Infertility, Female, run by Riyadh Fertility and Reproductive Health center at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 42 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Growth hormone/HPuFSH/GnRH antagonist and HPuFSH/GnRH antagonist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Nov 2017to Nov 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Serum anti-Müllerian hormone (AMH) less than 1.2 ng/ml
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Riyadh Fertility and Reproductive Health center
Giza
Usama M Fouda, Prof., +201095401375, umfrfouda@yahoo.com
About this study
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.
Read the 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.
- Conditions
- Infertility, Female
- Being tested
- Growth hormone/HPuFSH/GnRH antagonist, HPuFSH/GnRH antagonist
- Keywords
- IVF, Growth hormone, Poor responders
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth hormone/HPuFSH/GnRH antagonistDrug
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 antagonistDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Growth hormone/HPuFSH/GnRH antagonist | Experimental | The patients receive growth hormone Receives: Drug: Growth hormone/HPuFSH/GnRH antagonist |
| HPuFSH/GnRH antagonist | Active comparator | Growth hormone is not used Receives: Drug: HPuFSH/GnRH antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants who achieved a clinical pregnancy in a transfer cycle
Measured: Five weeks after embryo transfer
Secondary outcomes (1)
The number of participants who achieved a ongoing pregnancy in a transfer cycle
Measured: Eighteen weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start29 Nov 2017
- Primary completionJul 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riyadh Fertility and Reproductive Health center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hisham S Elshaer, Prof., Study chair, Prof. of Obstetrics and Gynecology,Faculty of medicine, Cairo university. Director of Riyadh Fertility and Reproductive Health centerUsama M Fouda, Prof., Study director, Prof. of Obstetrics and Gynecology,Faculty of medicine, Cairo university. Consultant at Riyadh Fertility and Reproductive Health centerMohammad Taymour, M.D, PhD, Principal investigator, Lecturer of Obstetrics and Gynecology, Faculty of medicine,Cairo university. Consultant at Riyadh Fertility and Reproductive Health centerAhmed A Wali, M.D, PhD, Principal investigator, Lecturer of Obstetrics and Gynecology,Faculty of medicine, Cairo university. Consultant at Riyadh Fertility and Reproductive Health centerFatma Faisel, M.D, PhD, Principal investigator, Lecturer of Obstetrics and Gynecology,Faculty of medicine, Cairo university. Consultant at Riyadh Fertility and Reproductive Health center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373149
- Sponsor's protocol ID
- Gh/poor responders
- Status last verified
- May 2020
- First submitted
- 7 Dec 2017
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23208461Sood 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.
PubMed 34808697
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth Hormone Co-treatment Within a GnRH Antagonist Protocol in Patients With Poor Ovarian Response
- ClinicalTrials.gov ID
- NCT03373149
- Acronym / sponsor ID
- Gh/poor responders
- Conditions
- Infertility, Female
- Keywords
- IVF, Growth hormone, Poor responders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Riyadh Fertility and Reproductive Health centerUniversity, hospital or other
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 14 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Growth hormone/HPuFSH/GnRH antagonist | Experimental | Drug: Growth hormone/HPuFSH/GnRH antagonistThe patients receive growth hormone |
| HPuFSH/GnRH antagonist | Active comparator | Drug: HPuFSH/GnRH antagonistGrowth hormone is not used |
Who may qualify
- Ages
- 35 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Serum anti-Müllerian hormone (AMH) less than 1.2 ng/ml
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Growth hormone/HPuFSH/GnRH antagonistGrowth 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. | Drug | Growth hormone/HPuFSH/GnRH antagonist |
| HPuFSH/GnRH antagonistHighly 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. | Drug | HPuFSH/GnRH antagonist |
Primary outcome
The number of participants who achieved a clinical pregnancy in a transfer cycle
Time frame: Five weeks after embryo transfer
1 secondary outcome
The number of participants who achieved a ongoing pregnancy in a transfer cycle
Time frame: Eighteen weeks after embryo transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Background: PubMed 23208461Eftekhar 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.
- Derived from this study: PubMed 34808697Sood 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hisham S Elshaer, Prof. study chair
Prof. of Obstetrics and Gynecology,Faculty of medicine, Cairo university. Director of Riyadh Fertility and Reproductive Health center
Usama M Fouda, Prof. 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 principal investigator
Lecturer of Obstetrics and Gynecology, Faculty of medicine,Cairo university. Consultant at Riyadh Fertility and Reproductive Health center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Growth hormone/HPuFSH/GnRH antagonist and HPuFSH/GnRH antagonist in people with Infertility, Female, run by Riyadh Fertility and Reproductive Health center at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Usama M Fouda, Prof. (+201095401375, umfrfouda@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants who achieved a clinical pregnancy in a transfer cycle (time frame: Five weeks after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03373149, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2020.