Poor Ovarian ReservePhase 1/2PPOSNCT07736261
Drospirenone-Primed Ovarian Stimulation Versus GnRH Antagonist Protocol in Poor Ovarian Responders Undergoing Freeze-All IVF/ICSI
A Phase 1/2 study testing Drospirenone drug and Cetrorelix 0.25 mg in people with Poor Ovarian Reserve and Infertility (IVF Patients), run by Ahmed Saad at 1 site in Egypt.
Trial summary
Participants will: Take either drospirenone (a daily pill) or the standard daily injection during their ovarian stimulation cycle, alongside their regular fertility hormone injections Undergo egg retrieval, with all resulting embryos frozen (no fresh embryo transfer in this study) Have a frozen embryo transferred in a… Read more about this study
- Who is it for?
- Ages 20 to 42 years, women only
- Conditions the study is for
- Poor Ovarian Reserve, Infertility (IVF Patients)
- What is being tested?
- Drospirenone drug and Cetrorelix 0.25 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2026to Nov 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Spontaneous menstrual cycles (21-35 days)
- Poor ovarian response per Bologna criteria (≥2 of 3): advanced age ≥40 or risk factor for POR; previous poor response (≤3 oocytes with conventional stimulation); abnormal ovarian reserve (AFC <7 or AMH <1.1 ng/mL)
- POSEIDON group recorded at enrollment (1-4) for stratified randomization and pre-specified subgroup description - corrects a known limitation of Bologna-only classification, which pools biologically distinct POR phenotypes
- Indication for IVF/ICSI
- Willing and able to undergo mandatory freeze-all/FET protocol
- Signed informed consent, including explicit acknowledgment that fresh transfer is not offered in either study arm
Who cannot join
- Contraindication to ovarian stimulation
- Known müllerian anomaly
- Uncontrolled systemic disease
- 5 prior failed IVF attempts
- Known contraindication to drospirenone (per product labeling, e.g., renal impairment, adrenal insufficiency, conditions predisposing to hyperkalemia)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Hawaa Fertility Center
Banhā, Qalyubia Governorate, 13512
Ahmed s saad, phD, 01221709989 ext. 020, drahmedsaad@live.com
walid a abdelateef, phD, 0201100434632 ext. 020, waleedabdelateef@gmail.com
About this study
Official title: Drospirenone-Primed Ovarian Stimulation (PPOS) Versus Flexible GnRH Antagonist Protocol in Poor Ovarian Responders Undergoing a Freeze-All Strategy: A Pilot Randomized Controlled Trial
Participants will:
- Take either drospirenone (a daily pill) or the standard daily injection during their ovarian stimulation cycle, alongside their regular fertility hormone injections
- Undergo egg retrieval, with all resulting embryos frozen (no fresh embryo transfer in this study)
- Have a frozen embryo transferred in a later cycle
- Complete two short questionnaires about their treatment experience - once before starting the injections/pills, and once after the stimulation phase ends
- Be followed to determine if the embryo transfer results in a pregnancy
Read the detailed description
Single-center, open-label, 1:1 parallel-group pilot RCT, stratified by POSEIDON group. Superiority framing is not used - this pilot is not powered for hypothesis testing on efficacy outcomes; those are reported descriptively with 95% confidence intervals.
Freeze-all is mandated in both arms by protocol (not patient choice). No patient is offered fresh transfer in either arm, so no patient is excluded for requesting one; this is stated explicitly in the consent process so expectations are set at enrollment.
Both arms use a unified flexible start, triggered by leading follicle diameter reaching 14mm - not a fixed calendar day. Rather than fixing both arms to the same stimulation day (which would not account for individual variability in follicular growth rate, a particular concern in POR), both the antagonist and the drospirenone are initiated on the same physiological trigger: once the leading follicle reaches 14mm, whichever arm the patient is randomized to. This achieves genuine unification across arms (identical starting criterion, applied identically) while remaining individualized to each patient's own stimulation pace. This design has direct precedent, as described in Section 2, and retrospective evidence in POR specifically favors flexible-start over fixed-day dosing on oocyte and fertilization outcomes without increased LH-surge risk.
- Conditions
- Poor Ovarian Reserve, Infertility (IVF Patients)
- Being tested
- Drospirenone drug, Cetrorelix 0.25 mg
- Keywords
- poor ovarian response, diminished ovarian reserve, Drospirenone, progestin primed ovarian stimulation, GnRH antagonist, Freeze all
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drospirenone drugDrug
A drug drospirenone in the form of 1 tablet / d from 14 mm follicle till hCG trigger day
Cetrorelix 0.25 mgDrug
Cetrorelix a drug injection daily sc. from 14 mm follicle till hCG trigger day
| Study group | Role | What they receive |
|---|---|---|
| Drospirenone | Experimental | 50 cases will receive drospirenone in the form of 1 tablet / d when the leading follicle reaches 14 mm till hCG trigger day Receives: Drug: Drospirenone drug |
| cetrorelix | Active comparator | 50 cases will receive cetrorelix when the leading follicle reaches 14 mm till hCG trigger day Receives: Drug: Cetrorelix 0.25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metaphase II (Mii) oocytes
Number of mature (MII) oocytes retrieved between drospirenone-PPOS and GnRH antagonist protocols, both using a unified flexible start (leading follicle 14mm), in POR patients undergoing a mandatory freeze-all strategy,
Measured: Day 0
Secondary outcomes (8)
Number of oocytes retrieved
Total numbers
Measured: Day 0
Fertilization rate 2 pronuclei (2PN)
Fertilization rate (2PN) check
Measured: on day 1
Quality of day-3 embryos
Quality of day-3 embryos (gradeing)
Measured: on day 3
LH measure
LH measure to follow premature LH surge (LH >15 mIU/mL on trigger day) and premature LH rise (LH >10 mIU/mL)
Measured: on trigger day ( 2 days before day 0)
Patient burden score
Patient-reported treatment burden and satisfaction, measured using the validated Controlled Ovarian Stimulation Impact Measure (COSI; four domains - Interference in Daily Life, Injection Burden, Psychological Health, Compliance Worry), administered at day 0. each patient will give a score from 0-4
Measured: Day 0
CPR ( clinical pregnancy rate)
Clinical pregnancy rate per embryo transfer
Measured: At 6 wks of pregnancy
Cost per cycle
Cost per stimulation cycle (drug cost only) in EGP
Measured: at day 0
Number of Day 3 embryos
Measure the numbers of day 3 embryos
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Ovarian ReserveStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 100 cases in this novel trial. 50 in each group will be randomized after taking 5 days of ovarian stimulation to either drospirenone tablet/d or cetrorelix injection/d till the day of hCG.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed Saad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Saad, Benha University
- Investigators
- Ahmed s Saad, phD, Study director, Professor of OB & GYN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736261
- Sponsor's protocol ID
- Hawaa-11
- Acronym
- PPOS
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the protocol excel sheet
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drospirenone-Primed Ovarian Stimulation (PPOS) Versus Flexible GnRH Antagonist Protocol in Poor Ovarian Responders Undergoing a Freeze-All Strategy: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07736261
- Acronym / sponsor ID
- PPOS / Hawaa-11
- Conditions
- Poor Ovarian Reserve, Infertility (IVF Patients)
- Keywords
- poor ovarian response, diminished ovarian reserve, Drospirenone, progestin primed ovarian stimulation, GnRH antagonist, Freeze all
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ahmed SaadUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 30 Jul 2026 (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.
Participants will:
- Take either drospirenone (a daily pill) or the standard daily injection during their ovarian stimulation cycle, alongside their regular fertility hormone injections
- Undergo egg retrieval, with all resulting embryos frozen (no fresh embryo transfer in this study)
- Have a frozen embryo transferred in a later cycle
- Complete two short questionnaires about their treatment experience - once before starting the injections/pills, and once after the stimulation phase ends
- Be followed to determine if the embryo transfer results in a pregnancy
Detailed description
Single-center, open-label, 1:1 parallel-group pilot RCT, stratified by POSEIDON group. Superiority framing is not used - this pilot is not powered for hypothesis testing on efficacy outcomes; those are reported descriptively with 95% confidence intervals.
Freeze-all is mandated in both arms by protocol (not patient choice). No patient is offered fresh transfer in either arm, so no patient is excluded for requesting one; this is stated explicitly in the consent process so expectations are set at enrollment.
Both arms use a unified flexible start, triggered by leading follicle diameter reaching 14mm - not a fixed calendar day. Rather than fixing both arms to the same stimulation day (which would not account for individual variability in follicular growth rate, a particular concern in POR), both the antagonist and the drospirenone are initiated on the same physiological trigger: once the leading follicle reaches 14mm, whichever arm the patient is randomized to. This achieves genuine unification across arms (identical starting criterion, applied identically) while remaining individualized to each patient's own stimulation pace. This design has direct precedent, as described in Section 2, and retrospective evidence in POR specifically favors flexible-start over fixed-day dosing on oocyte and fertilization outcomes without increased LH-surge risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 100 cases in this novel trial. 50 in each group will be randomized after taking 5 days of ovarian stimulation to either drospirenone tablet/d or cetrorelix injection/d till the day of hCG.
| Arm | Type | Receives |
|---|---|---|
| Drospirenone | Experimental | Drug: Drospirenone drug50 cases will receive drospirenone in the form of 1 tablet / d when the leading follicle reaches 14 mm till hCG trigger day |
| cetrorelix | Active comparator | Drug: Cetrorelix 0.25 mg50 cases will receive cetrorelix when the leading follicle reaches 14 mm till hCG trigger day |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Spontaneous menstrual cycles (21-35 days)
- Poor ovarian response per Bologna criteria (≥2 of 3): advanced age ≥40 or risk factor for POR; previous poor response (≤3 oocytes with conventional stimulation); abnormal ovarian reserve (AFC <7 or AMH <1.1 ng/mL)
- POSEIDON group recorded at enrollment (1-4) for stratified randomization and pre-specified subgroup description - corrects a known limitation of Bologna-only classification, which pools biologically distinct POR phenotypes
- Indication for IVF/ICSI
- Willing and able to undergo mandatory freeze-all/FET protocol
Key exclusion criteria (5 listed)
- Contraindication to ovarian stimulation
- Known müllerian anomaly
- Uncontrolled systemic disease
- 5 prior failed IVF attempts
- Known contraindication to drospirenone (per product labeling, e.g., renal impairment, adrenal insufficiency, conditions predisposing to hyperkalemia)
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 |
|---|---|---|
| Drospirenone drugA drug drospirenone in the form of 1 tablet / d from 14 mm follicle till hCG trigger day | Drug | Drospirenone |
| Cetrorelix 0.25 mgCetrorelix a drug injection daily sc. from 14 mm follicle till hCG trigger day | Drug | cetrorelix |
Primary outcome
Metaphase II (Mii) oocytes
Time frame: Day 0
Number of mature (MII) oocytes retrieved between drospirenone-PPOS and GnRH antagonist protocols, both using a unified flexible start (leading follicle 14mm), in POR patients undergoing a mandatory freeze-all strategy,
8 secondary outcomes
Number of oocytes retrieved
Time frame: Day 0
Fertilization rate 2 pronuclei (2PN)
Time frame: on day 1
Quality of day-3 embryos
Time frame: on day 3
LH measure
Time frame: on trigger day ( 2 days before day 0)
Patient burden score
Time frame: Day 0
CPR ( clinical pregnancy rate)
Time frame: At 6 wks of pregnancy
Cost per cycle
Time frame: at day 0
Number of Day 3 embryos
Time frame: Day 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Yes. the protocol excel sheet
Related trials for Poor Ovarian Reserve
RecruitingPhase 3
Ovulation Trigger Strategies in Low Ovarian Reserve (TRIGGERBEST)
Low Ovarian Reserve, Poor Ovarian Response
Recruiting
Ovarian PRP Injections for Improved Embryo Quality Using Embryo Quality Score
Infertility, Poor Ovarian Reserve
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.
Ahmed s Saad, phD study director
Professor of OB & GYN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Drospirenone drug and Cetrorelix 0.25 mg in people with Poor Ovarian Reserve and Infertility (IVF Patients), run by Ahmed Saad 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 6 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: opening soon, as of the sponsor's last update on 30 Jul 2026. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed S Saad, phD (+201221709989 ext. 020, drahmedsaad@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metaphase II (Mii) oocytes (time frame: Day 0). 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 30 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.