PCOS (Polycystic Ovary Syndrome)Phase 1/2PPOSNCT06608186
Can Drospirenone be Used to Prevent LH Surge in Controlled Ovarian Stimulation in PCOS?!
A Phase 1/2 study testing Cetrorelix drug and Drospirenone drug in people with PCOS (Polycystic Ovary Syndrome), run by Ahmed Saad at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if drospirenone can work to prevent LH surge in controlled ovarian stimulation in PCOS cases undergoing ART cycles. The main questions it aims to answer are: Can drospirenone prevent LH surge in controlled ovarian stimulation in PCOS cases ? Can it prevent the occurance of… Read more about this study
- Who is it for?
- Ages 20 to 38 years, women only
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome)
- What is being tested?
- Cetrorelix drug and Drospirenone drug
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 19 Jan 2025
- Phase
- Phase 1/2
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- PCOS was diagnosed according to the Rotterdam consensus criteria (two out of three of the following criteria):
- oligo- or anovulation
- clinical and/or biochemical signs of hyperandrogenism
- polycystic ovaries).
- A diagnosis of congenital adrenal hyperplasia, Cushing's syndrome, androgen-producing tumours, hyperprolactinemia and thyroid dysfunction were all rulled out.
Who cannot join
- age 38 years
- basal FSH level 12 mIU/mL
- previous ovarian surgery
- congenital uterine anomaly anomaly, intrauterine adhesion and male partner with non-obstructive azoospermia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Drospirenone be Used to Prevent LH Surge in Controlled Ovarian Stimulation in PCOS Cases
The goal of this clinical trial is to learn if drospirenone can work to prevent LH surge in controlled ovarian stimulation in PCOS cases undergoing ART cycles. The main questions it aims to answer are:
Can drospirenone prevent LH surge in controlled ovarian stimulation in PCOS cases ? Can it prevent the occurance of ovarian hyperstimulation?
Read more
Researchers will compare drospirenone to cetrorelix (A well known drug for such cases) to see if drospirenone works the same way.
Participants will:
Take drospirenone or cetrorelix from stimulation day 5 ( 5 days of ovarian stimulation) till day of hCG trigger
- monitoring will be done before the cycle and through the cycles with vaginal ultrasound assessment and lab testing
Read the detailed description
The goal of this novel clinical trial is to study if drospirenone can work to prevent LH surge in controlled ovarian stimulation in PCOS cases undergoing ART cycles in comparison to a gold standard drug cetrorelix:
All PCOS cases: 50 case in this novel trial. 25 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.
At the day of hCG, lab testing will be done in addition to ultrasound assessment by transvaginal probe. the tests are: progesterone, E2, LH.
Assesment will be done for the number quality of follicles and the number quality of embryos developed, development of OHSS, vitrification/thawing of embryos after 1 month then the clinical and chemical pregnancy rate.
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Being tested
- Cetrorelix drug, Drospirenone drug
- Keywords
- PCOS, PPOS, Drospirenone, Gn antagonist
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetrorelix drugDrug
Also called cetrorelix
a drug injection daily sc. from day 5 of stimulation till hCG trigger day
Drospirenone drugDrug
A drug drospirenone in the form of 1 tablet / d from day 5 of stimulation till hCG trigger day
| Study group | Role | What they receive |
|---|---|---|
| Drospirenone | Experimental | 25 cases will receive drospirenone in the form of 1 tablet / d from day 5 of stimulation till hCG trigger day Receives: Drug: Drospirenone drug |
| cetrorelix | Active comparator | 25 cases will receive cetrorelix from day 5 of stimualtion till hCG trigger day Receives: Drug: Cetrorelix drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of cases to develop OHSS
cases that will develop OHSS
Measured: 1 week
number of embryos
number of embryos developed
Measured: 5 days
Secondary outcomes (1)
clinical pregnancy rate
serum pregnancy test after thawing of the embryos and embryo transfer
Measured: 15 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 posted23 Sep 2024
- Study start1 Oct 2024
- Primary completion19 Jan 2025
- Study completion19 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOS (Polycystic Ovary Syndrome)Studies 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
- 50 case in this novel trial. 25 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
- 50 participants (actual)
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
- NCT06608186
- Sponsor's protocol ID
- Hawaa-10
- Acronym
- PPOS
- Status last verified
- Jan 2025
- First submitted
- 19 Sep 2024
- Last updated
- 22 Jan 2025
- 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 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Drospirenone be Used to Prevent LH Surge in Controlled Ovarian Stimulation in PCOS Cases
- ClinicalTrials.gov ID
- NCT06608186
- Acronym / sponsor ID
- PPOS / Hawaa-10
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Keywords
- PCOS, PPOS, Drospirenone, Gn antagonist
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ahmed SaadUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 19 Jan 2025 (actual)
- Study completion
- 19 Jan 2025 (actual)
- First posted
- 23 Sep 2024 (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 goal of this clinical trial is to learn if drospirenone can work to prevent LH surge in controlled ovarian stimulation in PCOS cases undergoing ART cycles. The main questions it aims to answer are:
Can drospirenone prevent LH surge in controlled ovarian stimulation in PCOS cases ? Can it prevent the occurance of ovarian hyperstimulation?
Researchers will compare drospirenone to cetrorelix (A well known drug for such cases) to see if drospirenone works the same way.
Participants will:
Take drospirenone or cetrorelix from stimulation day 5 ( 5 days of ovarian stimulation) till day of hCG trigger
- monitoring will be done before the cycle and through the cycles with vaginal ultrasound assessment and lab testing
Detailed description
The goal of this novel clinical trial is to study if drospirenone can work to prevent LH surge in controlled ovarian stimulation in PCOS cases undergoing ART cycles in comparison to a gold standard drug cetrorelix:
All PCOS cases: 50 case in this novel trial. 25 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.
At the day of hCG, lab testing will be done in addition to ultrasound assessment by transvaginal probe. the tests are: progesterone, E2, LH.
Assesment will be done for the number quality of follicles and the number quality of embryos developed, development of OHSS, vitrification/thawing of embryos after 1 month then the clinical and chemical pregnancy rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 50 case in this novel trial. 25 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 drug25 cases will receive drospirenone in the form of 1 tablet / d from day 5 of stimulation till hCG trigger day |
| cetrorelix | Active comparator | Drug: Cetrorelix drug25 cases will receive cetrorelix from day 5 of stimualtion till hCG trigger day |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- PCOS was diagnosed according to the Rotterdam consensus criteria (two out of three of the following criteria):
- A diagnosis of congenital adrenal hyperplasia, Cushing's syndrome, androgen-producing tumours, hyperprolactinemia and thyroid dysfunction were all rulled out.
Key exclusion criteria (4 listed)
- age 38 years
- basal FSH level 12 mIU/mL
- previous ovarian surgery
- congenital uterine anomaly anomaly, intrauterine adhesion and male partner with non-obstructive azoospermia.
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 |
|---|---|---|
| Cetrorelix drugAlso: cetrorelixa drug injection daily sc. from day 5 of stimulation till hCG trigger day | Drug | cetrorelix |
| Drospirenone drugA drug drospirenone in the form of 1 tablet / d from day 5 of stimulation till hCG trigger day | Drug | Drospirenone |
Primary outcome
number of cases to develop OHSS
Time frame: 1 week
cases that will develop OHSS
number of embryos
Time frame: 5 days
number of embryos developed
1 secondary outcome
clinical pregnancy rate
Time frame: 15 days 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 22 Jan 2025.
- Individual participant dataSharing planned: Yes. the protocol excel sheet
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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.
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 Cetrorelix drug and Drospirenone drug in people with PCOS (Polycystic Ovary Syndrome), 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 5 inclusion and 4 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 22 Jan 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 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?
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?
number of cases to develop OHSS (time frame: 1 week). 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 22 Jan 2025.