Polycystic Ovary SyndromeNCT05847660
Progesterone Primed Ovarian Stimulation Protocol Versus Antagonist Protocol for PCO Patient
A study testing Progesterone antagonist and conventional antagonist protocol in people with Polycystic Ovary Syndrome and Infertility, run by Fayoum University.
Trial summary
this study is designed to compare the Progesterone primed ovarian stimulation protocol versus the antagonist protocol as a method to stimulate PCO patients in ICSI cycles to decrease cost and decrease OHSS. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Infertility, IVF
- What is being tested?
- Progesterone antagonist and conventional antagonist protocol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 1 Jul 2024
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. PCO patients based on Rotterdam criteria (2003), including polycystic ovaries, oligo-anovulation, as well as the biochemical or clinical signs of hyperandrogenism (Rotterdam et al, 2003).
- 2. Age less than 40 years old. 3. Primary infertility for 2 years and secondary infertility for 1 year.
Who cannot join
- Non-PCO patients as:
- Congenital adrenal hyperplasia
- Hyperprolactinemia.
- Recurrent implantation failure.
- Hydrosalpinx.
- Uterine pathology.
- Uncontrolled medical disorder eg DM, HTN
- Male factor infertility.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled Study of Progesterone Primed Ovarian Stimulation Protocol Versus Antagonist Protocol for PCO Patients in Intracytoplasmic Sperm Injection Cycles
this study is designed to compare the Progesterone primed ovarian stimulation protocol versus the antagonist protocol as a method to stimulate PCO patients in ICSI cycles to decrease cost and decrease OHSS.
Read the detailed description
A Randomized controlled, non-blinded study (parallel-group study with 1:1 randomization) will be conducted at a Specialized Authorized IVF unit starting from January 2023 till completing the sample size. Randomization will be generated by a computer and held with one of the experimenters, and (n) of the black and red cards will be used for allocation concealment.
Participants: All PCO patients will be given informed consent about the study aims and written consent will be taken at the first visit to the infertility clinic of the Specialized Authorized IVF unit.
Patients will be categorized as (Group A) Progesterone primed ovarian stimulation protocol. (Group B) conventional antagonist protocol.
- Conditions
- Polycystic Ovary Syndrome, Infertility, IVF
- Being tested
- Progesterone antagonist, conventional antagonist protocol
- Keywords
- Polycystic ovary disease, ICSI, progesterone, antagonist protocol
- Medical subject headings
- Polycystic Ovary Syndrome, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progesterone antagonistDrug
Also called duphaston
Group (A): Women in progesterone primed (PPOS) will prescribed 30 mg oral dose of dydrogesterone (duphaston, Abbott, Egypt) from the 2nd day of the cycle and continued until triggering day. Vaginal sonography will be done for all patients since the 6th day of the cycle.
conventional antagonist protocolDrug
Also called 0.25 mg of cetrotide
Group (B): Women in the antagonist group will be monitored by transvaginal ultrasonography till the size of dominant follicles reached to 12-13 mm, 0.25 mg of cetrotide (Merck-Serono ,Germany) will be injected subcutaneously daily and continued until triggering day, follow up for all patients in both groups by transvaginal ultrasound every other day.
| Study group | Role | What they receive |
|---|---|---|
| Progesterone primed ovarian stimulation protocol. | Active comparator | Group (A): Women in progesterone primed (PPOS) will be prescribed a 30 mg oral dose of dydrogesterone (Duphaston, Abbott, Egypt) from the 2nd day of the cycle and continued until the triggering day. Vaginal sonography will be done for all patients since 6th day of the cycle. Receives: Drug: Progesterone antagonist |
| conventional antagonist protocol. | Active comparator | Group (B): Women in the antagonist group will be monitored by transvaginal ultrasonography till the size of dominant follicles reached to 12-13 mm, 0.25 mg of Cetrotide (Merck-Serono, Germany) will be injected subcutaneously daily and continued until triggering day, follow up for all patients in both groups by transvaginal ultrasound every other day. Receives: Drug: conventional antagonist protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of oocytes retrieved per patient
The number of oocyte retieved by ovum pick up after controlled ovarien stimulation
Measured: 12 months
The number of MII oocytes/per patient
the grade of maturity of oocyte under microscope
Measured: 12 months
The fertilization rate/per patient.
The number of fertilized oocyte by sperm
Measured: 12 months
Number of frozen embryos/per patient
the number of embryo frozen
Measured: 12 month
Secondary outcomes (2)
Incidence of early OHSS yes /no
size of th overies , presence of ascitis , pain and
Measured: 12 months
Pregnancy outcomes
- Chemical pregnancy will be determined by serum β hCG > 50 IU/L two weeks after ET.
- In addition, clinical pregnancy will be confirmed by detecting fetal heartbeats 2 weeks following the positive β hCG.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- 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
- Model description
- this is a randomized controlled non-blinded study. it will include 210 pt all of them PCO pt with infertility
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rehab abdelhamid aboshama, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847660
- Sponsor's protocol ID
- D 319
- Status last verified
- Apr 2023
- First submitted
- 27 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Progesterone Primed Ovarian Stimulation Protocol Versus Antagonist Protocol for PCO Patients in Intracytoplasmic Sperm Injection Cycles
- ClinicalTrials.gov ID
- NCT05847660
- Acronym / sponsor ID
- D 319
- Conditions
- Polycystic Ovary Syndrome, Infertility, IVF
- Keywords
- Polycystic ovary disease, ICSI, progesterone, antagonist protocol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 6 May 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.
this study is designed to compare the Progesterone primed ovarian stimulation protocol versus the antagonist protocol as a method to stimulate PCO patients in ICSI cycles to decrease cost and decrease OHSS.
Detailed description
A Randomized controlled, non-blinded study (parallel-group study with 1:1 randomization) will be conducted at a Specialized Authorized IVF unit starting from January 2023 till completing the sample size. Randomization will be generated by a computer and held with one of the experimenters, and (n) of the black and red cards will be used for allocation concealment.
Participants: All PCO patients will be given informed consent about the study aims and written consent will be taken at the first visit to the infertility clinic of the Specialized Authorized IVF unit.
Patients will be categorized as (Group A) Progesterone primed ovarian stimulation protocol. (Group B) conventional antagonist protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- this is a randomized controlled non-blinded study. it will include 210 pt all of them PCO pt with infertility
| Arm | Type | Receives |
|---|---|---|
| Progesterone primed ovarian stimulation protocol. | Active comparator | Drug: Progesterone antagonistGroup (A): Women in progesterone primed (PPOS) will be prescribed a 30 mg oral dose of dydrogesterone (Duphaston, Abbott, Egypt) from the 2nd day of the cycle and continued until the triggering day. Vaginal sonography will be done for all patients since 6th day of the cycle. |
| conventional antagonist protocol. | Active comparator | Drug: conventional antagonist protocolGroup (B): Women in the antagonist group will be monitored by transvaginal ultrasonography till the size of dominant follicles reached to 12-13 mm, 0.25 mg of Cetrotide (Merck-Serono, Germany) will be injected subcutaneously daily and continued until triggering day, follow up for all patients in both groups by transvaginal ultrasound every other day. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1. PCO patients based on Rotterdam criteria (2003), including polycystic ovaries, oligo-anovulation, as well as the biochemical or clinical signs of hyperandrogenism (Rotterdam et al, 2003).
- 2. Age less than 40 years old. 3. Primary infertility for 2 years and secondary infertility for 1 year.
Key exclusion criteria (8 listed)
- Non-PCO patients as:
- Congenital adrenal hyperplasia
- Hyperprolactinemia.
- Recurrent implantation failure.
- Hydrosalpinx.
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 |
|---|---|---|
| Progesterone antagonistAlso: duphastonGroup (A): Women in progesterone primed (PPOS) will prescribed 30 mg oral dose of dydrogesterone (duphaston, Abbott, Egypt) from the 2nd day of the cycle and continued until triggering day. Vaginal sonography will be done for all patients since the 6th day of the cycle. | Drug | Progesterone primed ovarian stimulation protocol. |
| conventional antagonist protocolAlso: 0.25 mg of cetrotideGroup (B): Women in the antagonist group will be monitored by transvaginal ultrasonography till the size of dominant follicles reached to 12-13 mm, 0.25 mg of cetrotide (Merck-Serono ,Germany) will be injected subcutaneously daily and continued until triggering day, follow up for all patients in both groups by transvaginal ultrasound every other day. | Drug | conventional antagonist protocol. |
Primary outcome
The number of oocytes retrieved per patient
Time frame: 12 months
The number of oocyte retieved by ovum pick up after controlled ovarien stimulation
The number of MII oocytes/per patient
Time frame: 12 months
the grade of maturity of oocyte under microscope
The fertilization rate/per patient.
Time frame: 12 months
The number of fertilized oocyte by sperm
Number of frozen embryos/per patient
Time frame: 12 month
the number of embryo frozen
2 secondary outcomes
Incidence of early OHSS yes /no
Time frame: 12 months
Pregnancy outcomes
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Progesterone antagonist and conventional antagonist protocol in people with Polycystic Ovary Syndrome and Infertility, run by Fayoum University.
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 8 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 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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 rehab A aboshama, Ass Professor (01156608221 ext. +2, ras07@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of oocytes retrieved per patient (time frame: 12 months). The study lists 4 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 6 May 2023.