Poor RespondersPhase 2/3NCT05900661
The Effect of Myo-inositol, Somatropin, and DHEA on Poor Ovarian Responders
A Phase 2/3 study testing myo-inositol, Somatropin and Dehydroepiandrosterone in people with Poor Responders, run by Beni-Suef University at 1 site in Egypt.
Trial summary
To evaulate the role of Myo-inositol, somatropin, DHEA on ICSI outcome in poor ovarian responder Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Poor Responders
- What is being tested?
- myo-inositol, Somatropin and Dehydroepiandrosterone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jul 2023to 30 Sep 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 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1-Infertile women who have one of the criteria of poor ovarian response as follows ;
- Antral follicle count less than 7
- Anti-Mullerian hormone level Less than 1.2 ng/ml 2- females with body mass index (BMI) from 19-25
Who cannot join
- Any endocrine or metabolic disorder such as polycystic ovary syndrome,
- 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.
Egypt1 site
Beni-suef university Hospital
Banī Suwayf, Beni Suweif Governorate, 62521
About this study
Official title: The Effect of Myo-inositol, Somatropin, and DHEA on Poor Ovarian Responders Undergoing ICSI : an Open Label Randomized Clinical Trial.
To evaulate the role of Myo-inositol, somatropin, DHEA on ICSI outcome in poor ovarian responder
Read the detailed description
Each patient will be subjected to:
Full history taking. Systematic clinical examination to assess the general condition, body mass index (BMI) and local pelvic physical findings and AFC by trans-vaginal ultrasound on D2 to 3 of menstruation.
Routine labs as CBC, liver \& kidney functions to exclude general disease as a contraindication for induction or pregnancy.
Blood sample will be obtained for assessment of basal serum levels of FSH, LH, E2 on days 2- 3 of the cycle. PRL, AMH and TSH Ovarian Stimulation The patients will begin injections of recombinant FSH (rFSH, Gonal-F; Merck-Serono, Italy) from day 2-3 of menstruation, with daily dose of 150-300 IU adjusted according to individual conditions on the basis of the antral follicle count (AFC),hormonal profile, age, body mass index (BMI), and previous ovarian response, according to the standard operating procedures of the center. .
For pituitary suppression, the patients will receive GnRH antagonist Cetrorelix (CETROTIDE 0.25Mg/d, Merck Serono, Germany) 0.25 mg/day subcutaneously from day 6 of induction until trigger day.
The serum LH, estradiol levels as well as number and size of follicles will be monitored every two days, starting from stimulation day 6 until the day of hCG injection.
- Conditions
- Poor Responders
- Being tested
- myo-inositol, Somatropin, Dehydroepiandrosterone
- Keywords
- Cetrorelix, DHEA, somatotropin, myo inositol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myo-inositolDrug
Also called Inofolic
myo-inositol 600µgm + folic acid 0.2 mg) 2 capsules at the morning and 2 capsules at the evening on empty stomach for 12 weeks produced by a Lo.Li pharma international ,Rome.Italy .
SomatropinDrug
growth hormone 2:Somatropin (4 IU for 1month), SEDICO ,6th of october .Egypt. 1 s.c injection every 3 days for at least 1 month.
DehydroepiandrosteroneDrug
Also called DHEA
DHEA 50 mg twice per day for 12 weeks in the last group , NATROL UK.Ltd.
| Study group | Role | What they receive |
|---|---|---|
| myo-inositol | Experimental | will recive Inofolic (myo-inositol 600µgm + folic acid 0.2 mg) 2 capsules at the morning and 2 capsules at the evening on empty stomach for 12 weeks Receives: Drug: myo-inositol |
| Somatropin | Experimental | Somatropin (4 IU for 1month), SEDICO ,6th of october .Egypt. 1 s.c injection every 3 days for at least 1 month. Receives: Drug: Somatropin |
| Dehydroepiandrosterone | Experimental | DHEA 50 mg twice per day for 12 weeks in the last group , NATROL UK.Ltd. Receives: Drug: Dehydroepiandrosterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and maturity of oocytes retrieved
Number and maturity of oocytes retrieved (M1/M2)
Measured: 1 month
Secondary outcomes (1)
chemical pregnancy rate
hcg positive
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start30 Jul 2023 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor RespondersStudies 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
- 300 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, Principal investigator, Faculty of Medicine Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900661
- Sponsor's protocol ID
- poor ovarian responders
- Status last verified
- Jul 2023
- First submitted
- 4 Jun 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Myo-inositol, Somatropin, and DHEA on Poor Ovarian Responders Undergoing ICSI : an Open Label Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05900661
- Acronym / sponsor ID
- poor ovarian responders
- Conditions
- Poor Responders
- Keywords
- Cetrorelix, DHEA, somatotropin, myo inositol
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 30 Jul 2023 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 12 Jun 2023 (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.
To evaulate the role of Myo-inositol, somatropin, DHEA on ICSI outcome in poor ovarian responder
Detailed description
Each patient will be subjected to:
Full history taking. Systematic clinical examination to assess the general condition, body mass index (BMI) and local pelvic physical findings and AFC by trans-vaginal ultrasound on D2 to 3 of menstruation.
Routine labs as CBC, liver \& kidney functions to exclude general disease as a contraindication for induction or pregnancy.
Blood sample will be obtained for assessment of basal serum levels of FSH, LH, E2 on days 2- 3 of the cycle. PRL, AMH and TSH Ovarian Stimulation The patients will begin injections of recombinant FSH (rFSH, Gonal-F; Merck-Serono, Italy) from day 2-3 of menstruation, with daily dose of 150-300 IU adjusted according to individual conditions on the basis of the antral follicle count (AFC),hormonal profile, age, body mass index (BMI), and previous ovarian response, according to the standard operating procedures of the center. .
For pituitary suppression, the patients will receive GnRH antagonist Cetrorelix (CETROTIDE 0.25Mg/d, Merck Serono, Germany) 0.25 mg/day subcutaneously from day 6 of induction until trigger day.
The serum LH, estradiol levels as well as number and size of follicles will be monitored every two days, starting from stimulation day 6 until the day of hCG injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| myo-inositol | Experimental | Drug: myo-inositolwill recive Inofolic (myo-inositol 600µgm + folic acid 0.2 mg) 2 capsules at the morning and 2 capsules at the evening on empty stomach for 12 weeks |
| Somatropin | Experimental | Drug: SomatropinSomatropin (4 IU for 1month), SEDICO ,6th of october .Egypt. 1 s.c injection every 3 days for at least 1 month. |
| Dehydroepiandrosterone | Experimental | Drug: DehydroepiandrosteroneDHEA 50 mg twice per day for 12 weeks in the last group , NATROL UK.Ltd. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 1-Infertile women who have one of the criteria of poor ovarian response as follows ;
- Antral follicle count less than 7
- Anti-Mullerian hormone level Less than 1.2 ng/ml 2- females with body mass index (BMI) from 19-25
Key exclusion criteria (4 listed)
- Any endocrine or metabolic disorder such as polycystic ovary syndrome,
- 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 |
|---|---|---|
| myo-inositolAlso: Inofolicmyo-inositol 600µgm + folic acid 0.2 mg) 2 capsules at the morning and 2 capsules at the evening on empty stomach for 12 weeks produced by a Lo.Li pharma international ,Rome.Italy . | Drug | myo-inositol |
| Somatropingrowth hormone 2:Somatropin (4 IU for 1month), SEDICO ,6th of october .Egypt. 1 s.c injection every 3 days for at least 1 month. | Drug | Somatropin |
| DehydroepiandrosteroneAlso: DHEADHEA 50 mg twice per day for 12 weeks in the last group , NATROL UK.Ltd. | Drug | Dehydroepiandrosterone |
Primary outcome
Number and maturity of oocytes retrieved
Time frame: 1 month
Number and maturity of oocytes retrieved (M1/M2)
1 secondary outcome
chemical pregnancy rate
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Poor Responders
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Transcutaneous Auricular Vagus Nerve Stimulation for Poor Weight-Loss Response to Incretin Receptor Agonists
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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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Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders
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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 principal investigator
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 myo-inositol, Somatropin and Dehydroepiandrosterone in people with Poor Responders, 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 3 inclusion and 4 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 18 Jul 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?
Number and maturity of oocytes retrieved (time frame: 1 month). 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 18 Jul 2023.