Poor Ovarian ReservePhase 2/3NCT05602090
Growth Hormone For Poor Ovarian Reserve Patients in ICSI Trials
A Phase 2/3 study testing 4 IU of recombinant GH (Somatotropin ) in people with Poor Ovarian Reserve, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Effect of Growth Hormone Adjuvant Therapy on ICSI Trials For Poor ovarian Reserve Patients Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Poor Ovarian Reserve
- What is being tested?
- 4 IU of recombinant GH (Somatotropin )
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2022to 30 Oct 2023
- Phase
- Phase 2/3
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- According to Bologna criteria (((at least two )))of the following features must be present:
- Advanced maternal age (40years).
- A previous poor ovarian response with 3 oocytes retrieved after conventional stimulation
- An abnormal ovarian reserve test (ORT)
- antral follicle count (AFC)<7 or
- anti-Müllerian hormone (AMH)<1.1ng/ml.
Who cannot join
- Any known contraindications to the approved fertility drugs.
- Any contraindications to growth hormone, pregnancy (to be ruled out and documented before GH treatment)
- 4- Hydrosalpinx 5- Uterine malformations or abnormal uterine cavity. 6- Basal FSH more than 17 IU. 7- Abnormal karyotyping 8- Partner with severe male factor 9- Uncontrolled endocrinopathies: DM, hyperthyroidism, hypothyroidism.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Beni-suef university
Banī Suwayf, Beni Suweif Governorate, 62521
Beni Suef University, 082 2318605 ext. 2, fom@med.bsu.edu.eg
About this study
Official title: Effect of Growth Hormone Adjuvant Therapy on ICSI Trials For Poor Ovarian Reserve Patients
Effect of Growth Hormone Adjuvant Therapy on ICSI Trials For Poor ovarian Reserve Patients
Read the detailed description
To study the effect of growth hormone as adjuvant treatment on the outcomes of ICSI trials in poor ovarian reserve patients.
- Conditions
- Poor Ovarian Reserve
- Being tested
- 4 IU of recombinant GH (Somatotropin )
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 IU of recombinant GH (Somatotropin )Drug
Also called (Somatotropin )
4 IU of recombinant GH
| Study group | Role | What they receive |
|---|---|---|
| Growth Hormone adjuvant treatment | Experimental | Growth hormone in this trial will use 4 IU of recombinant GH (Somatotropin, ) by day after day subcutaneous injection for 6 weeks before starting cycle. And on start day of induction ( Day 2 to 3) until the day of the human chorionic gonadotropin (hCG) trigger. Receives: Drug: 4 IU of recombinant GH (Somatotropin ) |
| control | No intervention | standard controlled ovarian stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rate
HCG positive
Measured: ICSI trial (1month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start1 Feb 2022
- Primary completion4 Sep 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Ovarian ReserveStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Abdallah Mohamed Salem, Beni-Suef University
- Investigators
- Beni-Suef University, Study chair, Faculty of Medicine Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602090
- Sponsor's protocol ID
- FMBSUREC/01022022/Hemida
- Status last verified
- Apr 2023
- First submitted
- 27 Oct 2022
- Last updated
- 28 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To study the effect of growth hormone as adjuvant treatment on the outcomes of ICSI trials in poor ovarian reserve patients
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Growth Hormone Adjuvant Therapy on ICSI Trials For Poor Ovarian Reserve Patients
- ClinicalTrials.gov ID
- NCT05602090
- Acronym / sponsor ID
- FMBSUREC/01022022/Hemida
- Conditions
- Poor Ovarian Reserve
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 4 Sep 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 1 Nov 2022 (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.
Effect of Growth Hormone Adjuvant Therapy on ICSI Trials For Poor ovarian Reserve Patients
Detailed description
To study the effect of growth hormone as adjuvant treatment on the outcomes of ICSI trials in poor ovarian reserve patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Growth Hormone adjuvant treatment | Experimental | Drug: 4 IU of recombinant GH (Somatotropin )Growth hormone in this trial will use 4 IU of recombinant GH (Somatotropin, ) by day after day subcutaneous injection for 6 weeks before starting cycle. And on start day of induction ( Day 2 to 3) until the day of the human chorionic gonadotropin (hCG) trigger. |
| control | No intervention | –standard controlled ovarian stimulation |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- According to Bologna criteria (((at least two )))of the following features must be present:
- Advanced maternal age (40years).
- A previous poor ovarian response with 3 oocytes retrieved after conventional stimulation
- An abnormal ovarian reserve test (ORT)
Key exclusion criteria (3 listed)
- Any known contraindications to the approved fertility drugs.
- Any contraindications to growth hormone, pregnancy (to be ruled out and documented before GH treatment)
- 4- Hydrosalpinx 5- Uterine malformations or abnormal uterine cavity. 6- Basal FSH more than 17 IU. 7- Abnormal karyotyping 8- Partner with severe male factor 9- Uncontrolled endocrinopathies: DM, hyperthyroidism, hypothyroidism.
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 |
|---|---|---|
| 4 IU of recombinant GH (Somatotropin )Also: (Somatotropin )4 IU of recombinant GH | Drug | Growth Hormone adjuvant treatment |
Primary outcome
pregnancy rate
Time frame: ICSI trial (1month)
HCG positive
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Individual participant dataSharing planned: No. To study the effect of growth hormone as adjuvant treatment on the outcomes of ICSI trials in poor ovarian reserve patients
Related trials for Poor Ovarian Reserve
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Drospirenone-Primed Ovarian Stimulation Versus GnRH Antagonist Protocol in Poor Ovarian Responders Undergoing Freeze-All IVF/ICSI
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Not yet recruiting
Impact of Day 2 Versus Day 3 Fresh Embryo Transfer on Live Birth Rate in Poor-Prognosis Patients
POSEIDON Category 4, Low Prognosis in Assisted Reproductive Technology
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Growth Hormone and Dehydroepiandrosterone Role in Vitro Fertilization
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Recruiting
Ovarian PRP Injections for Improved Embryo Quality Using Embryo Quality Score
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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.
Beni-Suef University study chair
Faculty of Medicine Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 4 IU of recombinant GH (Somatotropin ) in people with Poor Ovarian Reserve, run by Beni-Suef University 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 6 inclusion and 3 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 28 Apr 2023. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Sara A Salem, MD (01272842226 ext. 02, sara_abdallah100@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy rate (time frame: ICSI trial (1month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2023.