Ovary CystNCT05751681
Dydrogesterone-Primed Ovarian Stimulation Protocol Versus Gonadotropin Releasing Hormone Antagonist Protocol in ICSI
A study testing progestin primed ovarian stimulation protocol, dydrogesterone (Duphaston, Abbott) and Cetrotide in people with Ovary Cyst and Fertility Issues, run by Zagazig University at 1 site in Egypt.
Trial summary
GnRH antagonist protocol is currently a good strategy for controlled ovarian stimulation in women with PCOS undergoing IVF/ICSI cycles. Finding a protocol that can be a better alternative will help in improving the success rate of IVF/ICSI cycles Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Ovary Cyst, Fertility Issues
- What is being tested?
- progestin primed ovarian stimulation protocol, dydrogesterone (Duphaston, Abbott) and Cetrotide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2023to 20 Mar 2025
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All patients should be candidates for ICSI.
- Age between 20-40 years.
- Body mass index 18-35 kg/m2.
- Diagnosis of PCOS according to modified Rotterdam's criteria
Who cannot join
- 1) Any patient with contraindication to IVF treatment or pregnancy 2) Women with history of intra-uterine abnormality. 3) Severe endometriosis (grade 3 or 4) 4) Clinically significant systemic disease or other endocrinopathy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Zagazig University
Zagazig, 44511
mustapha fahmy, mcs, 01065644434, mafahmy21@gmail.com
About this study
Official title: Dydrogesterone-Primed Ovarian Stimulation Protocol Versus Gonadotropin Releasing Hormone Antagonist Protocol in Patients With Polycystic Ovary Syndrome Undergoing Intra-Cytoplasmic Sperm Injection
GnRH antagonist protocol is currently a good strategy for controlled ovarian stimulation in women with PCOS undergoing IVF/ICSI cycles. Finding a protocol that can be a better alternative will help in improving the success rate of IVF/ICSI cycles
Read the detailed description
Progesterone has potent restraint on hypothalamus-pituitary-ovarian axis. It acts on unidentified hypothalamic pulse oscillator neurons. In turn, it acts on gonadotropins releasing hormone (GnRH) secreting neurons leading to inhibition of GnRH secretion. This results in inhibition of both luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion from anterior pituitary. The effect of progesterone appears to decrease GnRH pulse frequency which results in slowing down LH pulse frequency and reducing LH plasma concentrations
- Conditions
- Ovary Cyst, Fertility Issues
- Being tested
- progestin primed ovarian stimulation protocol, dydrogesterone (Duphaston, Abbott), Cetrotide
- Keywords
- IVF,ICSI,success rate
- Medical subject headings
- Ovarian Cysts, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progestin primed ovarian stimulation protocolOther
progestin primed ovarian stimulation protocol
dydrogesterone (Duphaston, Abbott)Drug
20 mg oral dose of dydrogesterone (Duphaston, Abbott)
CetrotideDrug
Also called cetrorelix
0.25 mg of Cetrotide (gonadotropin releasing hormone (GnRH) antagonist)
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | Experimental | will be subjected to progestin primed ovarian stimulation protocol Women in group (A), will be prescribed 20 mg oral dose of dydrogesterone (Duphaston, Abbott) from the 2nd day of the cycle and continued until the trigger day. Transvaginal follicular monitoring will be done for all patients starting the 6th day of cycle. Receives: Other: progestin primed ovarian stimulation protocol; Drug: dydrogesterone (Duphaston, Abbott) |
| group (B) | Active comparator | Gonadotropin Releasing Hormone Antagonist Protocol when the size of dominant follicles reaches 12-13 mm, 0.25 mg of cetrotide (Merck-Serono Germany) will be injected subcutaneously daily and continued until the day of trigger shot. Receives: Other: progestin primed ovarian stimulation protocol; Drug: Cetrotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy (Number of MII oocytes retrieved)
this outcome means to measure Percentage (number) of MII oocytes retrieved During our study
Measured: 3 months
Efficacy (Maturation index)
Maturation index will be calculated: Rate of metaphase-II oocytes (MII) to total oocytes
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start20 Feb 2023
- Primary completion20 Apr 2024 (estimated)
- Study completion20 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovary CystStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- mostafa fahmy, mcs, Principal investigator, zagazig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751681
- Sponsor's protocol ID
- 9736-20-9-2022
- Status last verified
- Mar 2023
- First submitted
- 14 Dec 2022
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- 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 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dydrogesterone-Primed Ovarian Stimulation Protocol Versus Gonadotropin Releasing Hormone Antagonist Protocol in Patients With Polycystic Ovary Syndrome Undergoing Intra-Cytoplasmic Sperm Injection
- ClinicalTrials.gov ID
- NCT05751681
- Acronym / sponsor ID
- 9736-20-9-2022
- Conditions
- Ovary Cyst, Fertility Issues
- Keywords
- IVF,ICSI,success rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 20 Apr 2024 (estimated)
- Study completion
- 20 Mar 2025 (estimated)
- First posted
- 2 Mar 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.
GnRH antagonist protocol is currently a good strategy for controlled ovarian stimulation in women with PCOS undergoing IVF/ICSI cycles. Finding a protocol that can be a better alternative will help in improving the success rate of IVF/ICSI cycles
Detailed description
Progesterone has potent restraint on hypothalamus-pituitary-ovarian axis. It acts on unidentified hypothalamic pulse oscillator neurons. In turn, it acts on gonadotropins releasing hormone (GnRH) secreting neurons leading to inhibition of GnRH secretion. This results in inhibition of both luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion from anterior pituitary. The effect of progesterone appears to decrease GnRH pulse frequency which results in slowing down LH pulse frequency and reducing LH plasma concentrations
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A) | Experimental | Other: progestin primed ovarian stimulation protocol, Drug: dydrogesterone (Duphaston, Abbott)will be subjected to progestin primed ovarian stimulation protocol Women in group (A), will be prescribed 20 mg oral dose of dydrogesterone (Duphaston, Abbott) from the 2nd day of the cycle and continued until the trigger day. Transvaginal follicular monitoring will be done for all patients starting the 6th day of cycle. |
| group (B) | Active comparator | Other: progestin primed ovarian stimulation protocol, Drug: CetrotideGonadotropin Releasing Hormone Antagonist Protocol when the size of dominant follicles reaches 12-13 mm, 0.25 mg of cetrotide (Merck-Serono Germany) will be injected subcutaneously daily and continued until the day of trigger shot. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All patients should be candidates for ICSI.
- Age between 20-40 years.
- Body mass index 18-35 kg/m2.
- Diagnosis of PCOS according to modified Rotterdam's criteria
Key exclusion criteria (1 listed)
- 1) Any patient with contraindication to IVF treatment or pregnancy 2) Women with history of intra-uterine abnormality. 3) Severe endometriosis (grade 3 or 4) 4) Clinically significant systemic disease or other endocrinopathy.
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 |
|---|---|---|
| progestin primed ovarian stimulation protocolprogestin primed ovarian stimulation protocol | Other | Group (A), group (B) |
| dydrogesterone (Duphaston, Abbott)20 mg oral dose of dydrogesterone (Duphaston, Abbott) | Drug | Group (A) |
| CetrotideAlso: cetrorelix0.25 mg of Cetrotide (gonadotropin releasing hormone (GnRH) antagonist) | Drug | group (B) |
Primary outcome
Efficacy (Number of MII oocytes retrieved)
Time frame: 3 months
this outcome means to measure Percentage (number) of MII oocytes retrieved During our study
Efficacy (Maturation index)
Time frame: 3 months
Maturation index will be calculated: Rate of metaphase-II oocytes (MII) to total oocytes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: No
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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.
mostafa fahmy, mcs principal investigator
zagazig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing progestin primed ovarian stimulation protocol, dydrogesterone (Duphaston, Abbott) and Cetrotide in people with Ovary Cyst and Fertility Issues, run by Zagazig 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 1 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 2 Mar 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.
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 mostafa fahmy, mcs (01065644434, mafahmy21@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (Number of MII oocytes retrieved) (time frame: 3 months). The study lists 2 primary outcomes in all. 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 2 Mar 2023.