Invitro FertilizationNCT03684824
Accuracy of Ultrasound Markers Versus Biochemical Markers in Prediction of Ovarian Response in Obese Women Undergoing IVF/ICSI Treatment
A study testing Long luteal phase GnRH agonist protocol and Gonadotropins in people with Invitro Fertilization, run by Cairo University at 1 site in Egypt.
Trial summary
After detailed history and examination, long luteal protocol will be used for controlled ovarian hyperstimulation, so the patient will start treatment in day 21 of previous cycle, then in the early follicular phase of next cycle day 2-3 will have transvaginal sonography for assessment of total ovarian volume and… Read more about this study
- Who is it for?
- Ages 19 to 35 years, women only
- Conditions the study is for
- Invitro Fertilization
- What is being tested?
- Long luteal phase GnRH agonist protocol and Gonadotropins
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2018to Oct 2019
- Phase
- Interventional
- 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 19 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women between 20 and 35 age.
- BMI: 30 -35
Who cannot join
- Women less than 19 years or more than 35 years.
- BMI less than 30 or more than 35
- Women with Hypothyroidism.
- Women receiving any treatment may reduce their fertility e.g: chemotherapy.
- Women with recurrent IVF failure
Trial locations and contacts
1 site in 1 country.
Ameer Elsherief, MD contact
Egypt1 site
Ameer Elsherief
Minya
Ahmed Maged, MD, 01005227404, prof.ahmedmaged@gmail.com
Ameer elsherief, MD, 00201001204427, ameerelsherief@yahoo.com
About this study
After detailed history and examination, long luteal protocol will be used for controlled ovarian hyperstimulation, so the patient will start treatment in day 21 of previous cycle, then in the early follicular phase of next cycle day 2-3 will have transvaginal sonography for assessment of total ovarian volume and number of antral follicles measuring (2-10mm) in diameter. On the same day a venous sample will be obtained for the measurement of AMH, basal FSH and E2 levels
Read the detailed description
After detailed history and examination,A transvaginal ultrasound will be done using a transvaginal transducer with 7.5 MHz.
Each ovary will be measured in 3 planes maximal longitudinal, antero-posterior and transverse diameters, D1, D2 and D3 respectively. And ovarian volume will be calculated using the ellipsoid formula:
V = D1× D2 × D3 × 0.523 The volume of both ovaries will be added for the total basal ovarian volume (BOV).
The mean diameter of the antral follicles will be used by measuring the diameter of the follicle in two perpendicular directions.
The total AFC is calculated by counting the follicles with mean diameter 2-10mm in both ovaries.
- Ovulation induction protocol:- Long luteal phase agonist protocol will be used in all patients. Pituitary suppression will be done using daily subcutaneous injection of triptorelin acetate ( Decapeptyl 0.1mg, Ferring, Germany). Starting from day 21 of the previous cycle.
Controlled ovarian hyperstimulation will be done using daily intramuscular injection of highly purified Human Menopausal Gonadotrophins (Merional 75 IU/ml, IBSA, Switzerland), starting from day 2-3 of the stimulated cycle, total dose will be adjusted according to patient response.
Induction of oocyte maturation will be done using human chorionic gonadotrophins as an intramuscular injection of 10000 IU hCG (Choriomon 5000 i.u, IBSA, Switzerland). When there was sufficient ovarian response that defined as the presence of three or more ovarian follicles with mean diameter 18mm or more. [15]
- Monitoring of the cycle: The response to ovarian stimulation will be monitored by serial transvaginal ultrasound starting on day 6 of stimulation and onwards assessing the ovarian follicles number and diameter, as well as serum E2 level as indicated.
- Oocyte Retriveal: Oocyte retrieval will done (34-36 hours) after hCG injection, by transvaginal guided vacuumed oocyte aspiration using double lumen oocyte aspiration needle for flushing of the follicles.
- Measurement of FSH and E2 Levels: A blood sample will be withdrawn on day (2 - 3) of the menstrual cycle in which the patient will undergo stimulation, for estimation the basal FSH (mIU/ml) , E2 (pg/ml) and AMH (ng/ml) levels.
Both FSH and E2 will be tested using VIDAS equipment, both the FSH and E2 were measured by automated quantitative testing, using the ELFA technique (Enzyme Linked Fluorescent Assay). In the same way, AMH will be tested by Beckman Coulter, using GenII ELISA, USA.
- Conditions
- Invitro Fertilization
- Being tested
- Long luteal phase GnRH agonist protocol, Gonadotropins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long luteal phase GnRH agonist protocolDrug
Also called Decapeptyl 0.1mg amp
Pituitary suppression will be done using daily subcutaneous injection of triptorelin acetate ( Decapeptyl 0.1mg, Ferring, Germany). Starting from day 21 of the previous cycle
GonadotropinsDrug
Also called Merional 75 IU/ml, IBSA, Switzerland
Controlled ovarian hyperstimulation will be done using daily intramuscular injection of highly purified Human Menopausal Gonadotrophins (Merional 75 IU/ml, IBSA, Switzerland), starting from day 2-3 of the stimulated cycle, total dose will be adjusted according to patient response
| Study group | Role | What they receive |
|---|---|---|
| obese group | Other | 100 obese patients with BMI between 30 and 35 who are undergoing IVF/ICSI treatment for infertility Receives: Drug: Long luteal phase GnRH agonist protocol; Drug: Gonadotropins |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of retrieved oocytes
number of oocytes retrieved at day of ovum pick up
Measured: 34 hours after HCG triggering of ovulation
Secondary outcomes (1)
Clinical pregnancy rate
Ultrasound detection of intrauterine gestational sac
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 posted26 Sep 2018
- Study startSep 2018 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invitro FertilizationStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed maged, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684824
- Sponsor's protocol ID
- 39
- Status last verified
- Sep 2018
- First submitted
- 19 Sep 2018
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Ultrasound Markers Versus Biochemical Markers in Prediction of Ovarian Response in Obese Women Undergoing IVF/ICSI Treatment
- ClinicalTrials.gov ID
- NCT03684824
- Acronym / sponsor ID
- 39
- Conditions
- Invitro Fertilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 26 Sep 2018 (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.
After detailed history and examination, long luteal protocol will be used for controlled ovarian hyperstimulation, so the patient will start treatment in day 21 of previous cycle, then in the early follicular phase of next cycle day 2-3 will have transvaginal sonography for assessment of total ovarian volume and number of antral follicles measuring (2-10mm) in diameter. On the same day a venous sample will be obtained for the measurement of AMH, basal FSH and E2 levels
Detailed description
After detailed history and examination,A transvaginal ultrasound will be done using a transvaginal transducer with 7.5 MHz.
Each ovary will be measured in 3 planes maximal longitudinal, antero-posterior and transverse diameters, D1, D2 and D3 respectively. And ovarian volume will be calculated using the ellipsoid formula:
V = D1× D2 × D3 × 0.523 The volume of both ovaries will be added for the total basal ovarian volume (BOV).
The mean diameter of the antral follicles will be used by measuring the diameter of the follicle in two perpendicular directions.
The total AFC is calculated by counting the follicles with mean diameter 2-10mm in both ovaries.
- Ovulation induction protocol:- Long luteal phase agonist protocol will be used in all patients. Pituitary suppression will be done using daily subcutaneous injection of triptorelin acetate ( Decapeptyl 0.1mg, Ferring, Germany). Starting from day 21 of the previous cycle.
Controlled ovarian hyperstimulation will be done using daily intramuscular injection of highly purified Human Menopausal Gonadotrophins (Merional 75 IU/ml, IBSA, Switzerland), starting from day 2-3 of the stimulated cycle, total dose will be adjusted according to patient response.
Induction of oocyte maturation will be done using human chorionic gonadotrophins as an intramuscular injection of 10000 IU hCG (Choriomon 5000 i.u, IBSA, Switzerland). When there was sufficient ovarian response that defined as the presence of three or more ovarian follicles with mean diameter 18mm or more. [15]
- Monitoring of the cycle: The response to ovarian stimulation will be monitored by serial transvaginal ultrasound starting on day 6 of stimulation and onwards assessing the ovarian follicles number and diameter, as well as serum E2 level as indicated.
- Oocyte Retriveal: Oocyte retrieval will done (34-36 hours) after hCG injection, by transvaginal guided vacuumed oocyte aspiration using double lumen oocyte aspiration needle for flushing of the follicles.
- Measurement of FSH and E2 Levels: A blood sample will be withdrawn on day (2 - 3) of the menstrual cycle in which the patient will undergo stimulation, for estimation the basal FSH (mIU/ml) , E2 (pg/ml) and AMH (ng/ml) levels.
Both FSH and E2 will be tested using VIDAS equipment, both the FSH and E2 were measured by automated quantitative testing, using the ELFA technique (Enzyme Linked Fluorescent Assay). In the same way, AMH will be tested by Beckman Coulter, using GenII ELISA, USA.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| obese group | Other | Drug: Long luteal phase GnRH agonist protocol, Drug: Gonadotropins100 obese patients with BMI between 30 and 35 who are undergoing IVF/ICSI treatment for infertility |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women between 20 and 35 age.
- BMI: 30 -35
Key exclusion criteria (5 listed)
- Women less than 19 years or more than 35 years.
- BMI less than 30 or more than 35
- Women with Hypothyroidism.
- Women receiving any treatment may reduce their fertility e.g: chemotherapy.
- Women with recurrent IVF failure
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 |
|---|---|---|
| Long luteal phase GnRH agonist protocolAlso: Decapeptyl 0.1mg ampPituitary suppression will be done using daily subcutaneous injection of triptorelin acetate ( Decapeptyl 0.1mg, Ferring, Germany). Starting from day 21 of the previous cycle | Drug | obese group |
| GonadotropinsAlso: Merional 75 IU/ml, IBSA, SwitzerlandControlled ovarian hyperstimulation will be done using daily intramuscular injection of highly purified Human Menopausal Gonadotrophins (Merional 75 IU/ml, IBSA, Switzerland), starting from day 2-3 of the stimulated cycle, total dose will be adjusted according to patient response | Drug | obese group |
Primary outcome
number of retrieved oocytes
Time frame: 34 hours after HCG triggering of ovulation
number of oocytes retrieved at day of ovum pick up
1 secondary outcome
Clinical pregnancy rate
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 26 Sep 2018.
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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.
Ameer Elsherief, MD contact
Ahmed maged principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long luteal phase GnRH agonist protocol and Gonadotropins in people with Invitro Fertilization, 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 2 inclusion and 5 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 26 Sep 2018. 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.
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 (+2001005227404, prof.ahmedmaged@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of retrieved oocytes (time frame: 34 hours after HCG triggering of ovulation). 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 26 Sep 2018.