InfertilityPhase 2/3NCT07323329
Growth Hormone and Dehydroepiandrosterone Role in Vitro Fertilization
A Phase 2/3 study testing Somatropin (4IU for 1 month) plus, folic acid 400 mcg per day. and DHEA plus folic acid 400mcg per day in people with Infertility and Infertility (IVF Patients), run by Beni-Suef University at 1 site in Egypt.
Trial summary
The goal of this study is to evaluate the role of Somatropin and Dehydroepiandrosterone (DHEA) on ovarian reserve parameters and intracytoplasmic sperm injection (ICSI) outcome in poor ovarian responder. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Infertility, Infertility (IVF Patients)
- What is being tested?
- Somatropin (4IU for 1 month) plus, folic acid 400 mcg per day. and DHEA plus folic acid 400mcg per day
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2025to 12 Nov 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- At least two of the following three criteria had to be present after maximal stimulation:
- Advanced maternal age (>40 years) or any other risk factor for Poor Ovarian Response (POR).
- ≤3 oocytes with a conventional stimulation protocol).
- An abnormal ovarian reserve test [i.e. antral follicle count (AFC) less than 5-7 follicles or anti-Müllerian hormone (AMH) below 0.5-1.1 ng/ml].
Who cannot join
- Any endocrine or metabolic disorder such as hyperprolactinemia, diabetes and thyroid dysfunction.
- Any pelvic pathology such as hydrosalpinx, uterine anomaly.
- Any male factor infertility such as Oligo-Astheno-Teratozoospermia (OAT) or azoospermia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Beni-Suef University Hospital
Banī Suwayf, Beni Suweif Governorate, 62521
Marwa O. Elgendy, Associate professor, 00201021941935, amal.emam@yahoo.com
About this study
Official title: Growth Hormone and Dehydroepiandrosterone Effect on Poor Ovarian Reserve Patients During in Vitro Fertilization
The goal of this study is to evaluate the role of Somatropin and Dehydroepiandrosterone (DHEA) on ovarian reserve parameters and intracytoplasmic sperm injection (ICSI) outcome in poor ovarian responder.
The main question it aims to answer is:
Which intervention is more effective in increasing number and size of follicles? Participants will be followed 1 month before starting induction in growth hormone and 12 weeks for DHEA and through intracytoplasmic sperm injection (ICSI) cycle.
- Conditions
- Infertility, Infertility (IVF Patients)
- Being tested
- Somatropin (4IU for 1 month) plus, folic acid 400 mcg per day., DHEA plus folic acid 400mcg per day, control group
- Keywords
- Growth hormone, Infertility, IVF patients, Ovarian reserve
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatropin (4IU for 1 month) plus, folic acid 400 mcg per day.Drug
Patients will receive Somatropin (4IU for 1 month)1 S.C injection every 3 days for at least 1 month plus, folic acid 400 mcg per day.
DHEA plus folic acid 400mcg per dayDrug
Patients will receive DHEA 50 mg twice per day for 12 weeks plus folic acid 400mcg per day
control groupDietary supplement
Patients will receive folic acid 400 mcg per day
| Study group | Role | What they receive |
|---|---|---|
| Somatropin group | Experimental | Somatropin (4IU for 1 month) 1 S.C injection every 3 days for at least 1 month plus, folic acid 400mcg/day Receives: Drug: Somatropin (4IU for 1 month) plus, folic acid 400 mcg per day. |
| dehydroepiandrosterone | Experimental | dehydroepiandrosterone 50 mg twice per day for 12 weeks plus folic acid 400mcg per day Receives: Drug: DHEA plus folic acid 400mcg per day |
| Standard care | Active comparator | Patients will receive standard care will receive folic acid 400 mcg per day Receives: Dietary Supplement: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of mature oocyte
Measured: 12 weeks
Secondary outcomes (1)
pregnancy rate
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start10 Oct 2025
- Primary completion15 Oct 2026 (estimated)
- Study completion12 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies 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
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasnaa Osama, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323329
- Sponsor's protocol ID
- FMBSUREC/01092024/Ragab
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Casson PR, Lindsay MS, Pisarska MD, Carson SA, Buster JE. Dehydroepiandrosterone supplementation augments ovarian stimulation in poor responders: a case series. Hum Reprod. 2000 Oct;15(10):2129-32. doi: 10.1093/humrep/15.10.2129.
PubMed 11006185
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth Hormone and Dehydroepiandrosterone Effect on Poor Ovarian Reserve Patients During in Vitro Fertilization
- ClinicalTrials.gov ID
- NCT07323329
- Acronym / sponsor ID
- FMBSUREC/01092024/Ragab
- Conditions
- Infertility, Infertility (IVF Patients)
- Keywords
- Growth hormone, Infertility, IVF patients, Ovarian reserve
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 12 Nov 2026 (estimated)
- First posted
- 7 Jan 2026 (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.
The goal of this study is to evaluate the role of Somatropin and Dehydroepiandrosterone (DHEA) on ovarian reserve parameters and intracytoplasmic sperm injection (ICSI) outcome in poor ovarian responder.
The main question it aims to answer is:
Which intervention is more effective in increasing number and size of follicles? Participants will be followed 1 month before starting induction in growth hormone and 12 weeks for DHEA and through intracytoplasmic sperm injection (ICSI) cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Somatropin group | Experimental | Drug: Somatropin (4IU for 1 month) plus, folic acid 400 mcg per day.Somatropin (4IU for 1 month) 1 S.C injection every 3 days for at least 1 month plus, folic acid 400mcg/day |
| dehydroepiandrosterone | Experimental | Drug: DHEA plus folic acid 400mcg per daydehydroepiandrosterone 50 mg twice per day for 12 weeks plus folic acid 400mcg per day |
| Standard care | Active comparator | Dietary Supplement: control groupPatients will receive standard care will receive folic acid 400 mcg per day |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Advanced maternal age (>40 years) or any other risk factor for Poor Ovarian Response (POR).
- ≤3 oocytes with a conventional stimulation protocol).
- An abnormal ovarian reserve test [i.e. antral follicle count (AFC) less than 5-7 follicles or anti-Müllerian hormone (AMH) below 0.5-1.1 ng/ml].
Key exclusion criteria (3 listed)
- Any endocrine or metabolic disorder such as hyperprolactinemia, diabetes and thyroid dysfunction.
- Any pelvic pathology such as hydrosalpinx, uterine anomaly.
- Any male factor infertility such as Oligo-Astheno-Teratozoospermia (OAT) or azoospermia
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 |
|---|---|---|
| Somatropin (4IU for 1 month) plus, folic acid 400 mcg per day.Patients will receive Somatropin (4IU for 1 month)1 S.C injection every 3 days for at least 1 month plus, folic acid 400 mcg per day. | Drug | Somatropin group |
| DHEA plus folic acid 400mcg per dayPatients will receive DHEA 50 mg twice per day for 12 weeks plus folic acid 400mcg per day | Drug | dehydroepiandrosterone |
| control groupPatients will receive folic acid 400 mcg per day | Dietary supplement | Standard care |
Primary outcome
The number of mature oocyte
Time frame: 12 weeks
1 secondary outcome
pregnancy rate
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Background: PubMed 11006185Casson PR, Lindsay MS, Pisarska MD, Carson SA, Buster JE. Dehydroepiandrosterone supplementation augments ovarian stimulation in poor responders: a case series. Hum Reprod. 2000 Oct;15(10):2129-32. doi: 10.1093/humrep/15.10.2129.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
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 Somatropin (4IU for 1 month) plus, folic acid 400 mcg per day. and DHEA plus folic acid 400mcg per day in people with Infertility and Infertility (IVF Patients), 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 4 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: looking for participants now, as of the sponsor's last update on 7 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of mature oocyte (time frame: 12 weeks). 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 NCT07323329, which also lists 1 linked publication.
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 7 Jan 2026.