PPOSPhase 3PPOS vs GnRHNCT06868576
PPOS Protocol Versus GnRH Anatagonist for Expected Normal Responder Patients Undergoing ART : a Randomized Clinical Trial
A Phase 3 study testing Dydrogesterone Oral Tablet and Cetrorelix (Cetrotide) in people with PPOS and GnRH Antagonist, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
The aim of this study is to compare the efficacy and safety of Progestin-Primed Ovarian Stimulation (PPOS) protocol versus the fixed GnRH antagonist protocol in expected normal responder patients undergoing intracytoplasmic sperm injection (ICSI) with frozen-thawed embryo transfer (FET). Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- PPOS, GnRH Antagonist, Assisted Reproductive Techniques
- What is being tested?
- Dydrogesterone Oral Tablet and Cetrorelix (Cetrotide)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2023to 28 Feb 2025
- Phase
- Phase 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 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • Women who had history of infertility for ≥1 year.
- Women whose age <40 years old by the end of the study.
- Anti-Mullerian hormone > 1.2 ng/ml.
- Antral follicle count ≥ 5.
Who cannot join
- • Age ≥ 40 years old.
- Women who are diagnosed as polycystic ovarian syndrome.
- Women with endometriosis stage 3 or 4.
- Documented previous IVF/ICSI cycles with no oocytes retrieved.
- Women with contraindications to controlled ovarian stimulation.
- Patients who refuse to share in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Progestin-Primed Ovarian Stimulation Versus Gonadotrophin-Releasing Hormone Antagonist for Patients Undergoing Assisted Reproductive Technology: a Randomized Clinical Trial
The aim of this study is to compare the efficacy and safety of Progestin-Primed Ovarian Stimulation (PPOS) protocol versus the fixed GnRH antagonist protocol in expected normal responder patients undergoing intracytoplasmic sperm injection (ICSI) with frozen-thawed embryo transfer (FET). By evaluating key clinical outcomes, including ovarian response, embryological parameters, and pregnancy rates, this study seeks to determine the relative advantages and limitations of each protocol.
Read the detailed description
In this prospective, non-inferiority trial, we will compare the efficacy and safety of the GnRH antagonist and PPOS protocols in 328 infertile women undergoing ICSI in Kasr Al-Ainy IVF department, Cairo University, Egypt. Before the trial, investigators were required to provide all information related to the clinical trial, including the possible benefits and risks, other therapeutic choices and the right to withdraw, via a written consent. After being provided with sufficient time to decide whether to participate and the opportunity to ask questions, all participants were required to provide written informed consent before study inclusion.
- Conditions
- PPOS, GnRH Antagonist, Assisted Reproductive Techniques
- Being tested
- Dydrogesterone Oral Tablet, Cetrorelix (Cetrotide)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dydrogesterone Oral TabletDrug
Dydrogesterone 20mg tablets daily in PPOS protocol in ovarian stimulation starting from day 2 or 3 of the menstrual cycle until the triggering day
Cetrorelix (Cetrotide)Drug
This will be the conventional antagonist in ovarian stimulation given from day 6 of the menstrual cycle until the triggering day
| Study group | Role | What they receive |
|---|---|---|
| patients that will undergo progestin primed ovarian stimulation (PPOS) protocol using dydrogesterone | Experimental | Not described Receives: Drug: Dydrogesterone Oral Tablet |
| patients that will receive the conventional GnRH antagonist. | Active comparator | Not described Receives: Drug: Cetrorelix (Cetrotide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy
The presence of fetal pulsations by ultrasound at 7 weeks of gestational age
Measured: 7 weeks of gestational age
Secondary outcomes (4)
Incidence of moderate/severe OHSS
Measured: before triggering injection and within 9 days after triggering injection
Number of metaphase 2 oocytes
Measured: within 1 day of ovum pick up
number of 2 PN embryos
Measured: within 1 day of ovum pick up
Biochemical pregnancy
Quantitative Beta chorinioic gonadotrophin (B-HCG) hormone levels in blood 2 to 3 weeks after embryo transfer.
Measured: 2-3 weeks 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 posted11 Mar 2025
- Study start3 Jan 2023
- Primary completion31 Oct 2024
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PPOSStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three hundred twenty-eight women will be divided into 2 groups (A and B), each group will consist of 164 patients: \*Group A (Study group): Includes 164 patients that will undergo progestin primed ovarian stimulation (PPOS) protocol using dydrogesterone. \*Group B (control group): Includes 164 patients that will receive the conventional GnRH antagonist.
- Masking
- None (open label)
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hassan Badawy Gadallah, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868576
- Sponsor's protocol ID
- MD-10-2023
- Acronym
- PPOS vs GnRH
- Status last verified
- Mar 2025
- First submitted
- 18 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progestin-Primed Ovarian Stimulation Versus Gonadotrophin-Releasing Hormone Antagonist for Patients Undergoing Assisted Reproductive Technology: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06868576
- Acronym / sponsor ID
- PPOS vs GnRH / MD-10-2023
- Conditions
- PPOS, GnRH Antagonist, Assisted Reproductive Techniques
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 11 Mar 2025 (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.
The aim of this study is to compare the efficacy and safety of Progestin-Primed Ovarian Stimulation (PPOS) protocol versus the fixed GnRH antagonist protocol in expected normal responder patients undergoing intracytoplasmic sperm injection (ICSI) with frozen-thawed embryo transfer (FET). By evaluating key clinical outcomes, including ovarian response, embryological parameters, and pregnancy rates, this study seeks to determine the relative advantages and limitations of each protocol.
Detailed description
In this prospective, non-inferiority trial, we will compare the efficacy and safety of the GnRH antagonist and PPOS protocols in 328 infertile women undergoing ICSI in Kasr Al-Ainy IVF department, Cairo University, Egypt. Before the trial, investigators were required to provide all information related to the clinical trial, including the possible benefits and risks, other therapeutic choices and the right to withdraw, via a written consent. After being provided with sufficient time to decide whether to participate and the opportunity to ask questions, all participants were required to provide written informed consent before study inclusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Three hundred twenty-eight women will be divided into 2 groups (A and B), each group will consist of 164 patients: *Group A (Study group): Includes 164 patients that will undergo progestin primed ovarian stimulation (PPOS) protocol using dydrogesterone. *Group B (control group): Includes 164 patients that will receive the conventional GnRH antagonist.
| Arm | Type | Receives |
|---|---|---|
| patients that will undergo progestin primed ovarian stimulation (PPOS) protocol using dydrogesterone | Experimental | Drug: Dydrogesterone Oral Tablet |
| patients that will receive the conventional GnRH antagonist. | Active comparator | Drug: Cetrorelix (Cetrotide) |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • Women who had history of infertility for ≥1 year.
Key exclusion criteria (6 listed)
- • Age ≥ 40 years old.
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 |
|---|---|---|
| Dydrogesterone Oral TabletDydrogesterone 20mg tablets daily in PPOS protocol in ovarian stimulation starting from day 2 or 3 of the menstrual cycle until the triggering day | Drug | patients that will undergo progestin primed ovarian stimulation (PPOS) protocol using dydrogesterone |
| Cetrorelix (Cetrotide)This will be the conventional antagonist in ovarian stimulation given from day 6 of the menstrual cycle until the triggering day | Drug | patients that will receive the conventional GnRH antagonist. |
Primary outcome
clinical pregnancy
Time frame: 7 weeks of gestational age
The presence of fetal pulsations by ultrasound at 7 weeks of gestational age
4 secondary outcomes
Incidence of moderate/severe OHSS
Time frame: before triggering injection and within 9 days after triggering injection
Number of metaphase 2 oocytes
Time frame: within 1 day of ovum pick up
number of 2 PN embryos
Time frame: within 1 day of ovum pick up
Biochemical pregnancy
Time frame: 2-3 weeks after embryo transfer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dydrogesterone Oral Tablet and Cetrorelix (Cetrotide) in people with PPOS and GnRH Antagonist, run by Kasr El Aini Hospital 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 6 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: finished, as of the sponsor's last update on 11 Mar 2025. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical pregnancy (time frame: 7 weeks of gestational age). 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 11 Mar 2025.