Ovarian ReservePhase 4NCT02896023
Predictors of Ovarian Reserve in Infertile Women
A Phase 4 study testing human menopausal gonadotropin in people with Ovarian Reserve, run by Cairo University at 1 site in Egypt.
Trial summary
Patients will be subjected to: A. Clinical evaluation including history and examination B. Ultrasonographic evaluation of Ovarian Morphometry: Patients will be evaluated in early follicular phase of the menstrual flow (cycle's days 1-3) by TVS scanning; using MINDRAY DP-1100 Plus Digital Machine, 7.5MHz, China, by… Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Ovarian Reserve
- What is being tested?
- human menopausal gonadotropin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2016to Mar 2020
- Phase
- Phase 4
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- less than 39 years old,
- normal menstrual cycle with a range of 24 to 35 days
- normal seum prolactin.
- normal uterine cavity determined by previous hysterosalpingography or hysteroscopy
Who cannot join
- smokers
- endometriosis
- Women with endometriosis;
- abnormal endocrine functions such as diabetes mellitus, thyroid disorders, and adrenal abnormalities; general diseases, those with ovarian cysts, or those who have azospermia partners.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alainy medical school
Cairo, 12151
Ahmed Maged, MD, 01005227404, prof.ahmedmaged@gmail.com
About this study
Official title: Sonographic and Laboratory Predictors of Ovarian Reserve in Infertile Women
Patients will be subjected to:
- Clinical evaluation including history and examination
- Ultrasonographic evaluation of Ovarian Morphometry:
Read more
- Patients will be evaluated in early follicular phase of the menstrual flow (cycle's days 1-3) by TVS scanning; using MINDRAY DP-1100 Plus Digital Machine, 7.5MHz, China, by only one examiner to avoid inter-observer variations.
- Ovarian images will be procured in the sagittal and coronal planes and the frozen image reflecting the largest ovarian dimensions will be utilized for the measurement of ovarian length, width, and height (cm) as per standard clinical practice. Mean values of both ovaries will be used. Ovarian volume will be calculated from ellipsoid volume formula, {Ovarian volume = Ovarian Width (D1) × Ovarian Length (D2) ×Ovarian Height (D3) × 0 .523}
- Antral follicle count will be determined for each patient
- Laboratory Evaluation:
Blood samples will be collected in the early follicular phase. Samples will be immediately centrifuged and serum saved at -20 degrees for measurement of:
- Anti Mullerian Hormone (AMH)
- Follicle Stimulating Hormone (FSH)
- Estradiol (E2) Using electro-chemiluminescence immunoassay (ELICA)
Read the detailed description
Patients will be subjected to:
- Clinical evaluation including history and examination
- Ultrasonographic evaluation of Ovarian Morphometry:
- Patients will be evaluated in early follicular phase of the menstrual flow (cycle's days 1-3) by TVS scanning; using MINDRAY DP-1100 Plus Digital Machine, 7.5MHz, China, by only one examiner to avoid inter-observer variations.
- Ovarian images will be procured in the sagittal and coronal planes and the frozen image reflecting the largest ovarian dimensions will be utilized for the measurement of ovarian length, width, and height (cm) as per standard clinical practice. Mean values of both ovaries will be used. Ovarian volume will be calculated from ellipsoid volume formula, {Ovarian volume = Ovarian Width (D1) × Ovarian Length (D2) ×Ovarian Height (D3) × 0 .523}
- Antral follicle count will be determined for each patient
- Laboratory Evaluation:
Blood samples will be collected in the early follicular phase. Samples will be immediately centrifuged and serum saved at -20 degrees for measurement of:
- Anti Mullerian Hormone (AMH)
- Follicle Stimulating Hormone (FSH)
- Estradiol (E2) Using electro-chemiluminescence immunoassay (ELICA)
- Conditions
- Ovarian Reserve
- Being tested
- human menopausal gonadotropin
- Keywords
- predictors, ovarian reserve, infertile women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human menopausal gonadotropinDrug
Also called menogon
Induction of ovulation followed by ICSI
| Study group | Role | What they receive |
|---|---|---|
| pregnant | Active comparator | women with positive pregnancy test after induction of ovulation and ICSI Receives: Drug: human menopausal gonadotropin |
| Not pregnant | Active comparator | women with negative pregnancy test after induction of ovulation and ICSI Receives: Drug: human menopausal gonadotropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
positive pregnancy test
Measured: 14 days 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 posted12 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionJan 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian ReserveStudies of the same condition, open and under way.
- More trials run by Cairo 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, Kasr Alainy medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896023
- Sponsor's protocol ID
- 154
- Status last verified
- Sep 2019
- First submitted
- 29 Aug 2016
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic and Laboratory Predictors of Ovarian Reserve in Infertile Women
- ClinicalTrials.gov ID
- NCT02896023
- Acronym / sponsor ID
- 154
- Conditions
- Ovarian Reserve
- Keywords
- predictors, ovarian reserve, infertile women
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 12 Sep 2016 (estimated)
- 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.
Patients will be subjected to:
- Clinical evaluation including history and examination
- Ultrasonographic evaluation of Ovarian Morphometry:
- Patients will be evaluated in early follicular phase of the menstrual flow (cycle's days 1-3) by TVS scanning; using MINDRAY DP-1100 Plus Digital Machine, 7.5MHz, China, by only one examiner to avoid inter-observer variations.
- Ovarian images will be procured in the sagittal and coronal planes and the frozen image reflecting the largest ovarian dimensions will be utilized for the measurement of ovarian length, width, and height (cm) as per standard clinical practice. Mean values of both ovaries will be used. Ovarian volume will be calculated from ellipsoid volume formula, {Ovarian volume = Ovarian Width (D1) × Ovarian Length (D2) ×Ovarian Height (D3) × 0 .523}
- Antral follicle count will be determined for each patient
- Laboratory Evaluation:
Blood samples will be collected in the early follicular phase. Samples will be immediately centrifuged and serum saved at -20 degrees for measurement of:
- Anti Mullerian Hormone (AMH)
- Follicle Stimulating Hormone (FSH)
- Estradiol (E2) Using electro-chemiluminescence immunoassay (ELICA)
Detailed description
Patients will be subjected to:
- Clinical evaluation including history and examination
- Ultrasonographic evaluation of Ovarian Morphometry:
- Patients will be evaluated in early follicular phase of the menstrual flow (cycle's days 1-3) by TVS scanning; using MINDRAY DP-1100 Plus Digital Machine, 7.5MHz, China, by only one examiner to avoid inter-observer variations.
- Ovarian images will be procured in the sagittal and coronal planes and the frozen image reflecting the largest ovarian dimensions will be utilized for the measurement of ovarian length, width, and height (cm) as per standard clinical practice. Mean values of both ovaries will be used. Ovarian volume will be calculated from ellipsoid volume formula, {Ovarian volume = Ovarian Width (D1) × Ovarian Length (D2) ×Ovarian Height (D3) × 0 .523}
- Antral follicle count will be determined for each patient
- Laboratory Evaluation:
Blood samples will be collected in the early follicular phase. Samples will be immediately centrifuged and serum saved at -20 degrees for measurement of:
- Anti Mullerian Hormone (AMH)
- Follicle Stimulating Hormone (FSH)
- Estradiol (E2) Using electro-chemiluminescence immunoassay (ELICA)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregnant | Active comparator | Drug: human menopausal gonadotropinwomen with positive pregnancy test after induction of ovulation and ICSI |
| Not pregnant | Active comparator | Drug: human menopausal gonadotropinwomen with negative pregnancy test after induction of ovulation and ICSI |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- less than 39 years old,
- normal menstrual cycle with a range of 24 to 35 days
- normal seum prolactin.
- normal uterine cavity determined by previous hysterosalpingography or hysteroscopy
Key exclusion criteria (4 listed)
- smokers
- endometriosis
- Women with endometriosis;
- abnormal endocrine functions such as diabetes mellitus, thyroid disorders, and adrenal abnormalities; general diseases, those with ovarian cysts, or those who have azospermia partners.
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 |
|---|---|---|
| human menopausal gonadotropinAlso: menogonInduction of ovulation followed by ICSI | Drug | Not pregnant, pregnant |
Primary outcome
positive pregnancy test
Time frame: 14 days 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 23 Sep 2019.
- Individual participant dataSharing planned: Yes
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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.
Ahmed Maged, MD principal investigator
Kasr Alainy medical school
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing human menopausal gonadotropin in people with Ovarian Reserve, run by Cairo 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 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 23 Sep 2019. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Ahmed Maged, MD (01005227404, prof.ahmedmaged@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positive pregnancy test (time frame: 14 days after embryo transfer). 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 23 Sep 2019.