PCOSNCT05939284
Progesterone-Primed Ovarian Simulation in Controlled-ovarian Simulation of Infertile PCOS Patients
A study testing Injection of Cetrorelix and Oral insertion of dydrogeserone in people with PCOS, run by Zagazig University at 1 site in Egypt.
Trial summary
The study evaluated the safety and efficacy of the progesterone-primed ovarian stimulation (PPOS) coupled with gonadotropin (FSH) for infertile women with polycystic ovary syndrome (PCOS) who were assigned for ICSI and frozen blastocyst transfer. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- PCOS
- What is being tested?
- Injection of Cetrorelix and Oral insertion of dydrogeserone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 25 Jan 2023
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertile PCOS women;
- aged 20-35 years;
- had BMI <35 kg/m2.
Who cannot join
- Women who were younger than 20 or older than 35 years,
- obese of grade II or III,
- had poor OR, other causes of infertility,
- had previous attempts of IVF, had a history of repeated pregnancy loss.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Progesterone-Primed Ovarian Stimulation Might be a Safe and Effective Alternative to GnRH-antagonist Protocol for Controlled-Ovarian Stimulation of Infertile PCOS Women
The study evaluated the safety and efficacy of the progesterone-primed ovarian stimulation (PPOS) coupled with gonadotropin (FSH) for infertile women with polycystic ovary syndrome (PCOS) who were assigned for ICSI and frozen blastocyst transfer.
200 infertile women were divided randomly into Group C, which received Cetrorelix injection (0.25 mg daily) on day-6, and Group S, which received oral dydrogesterone (20 mg/day) on day-2 of the menstrual cycle till the trigger day. All patients received an FSH injection of 225 IU daily from day-2 till triggering day. ICSI was performed and day-5 blastocysts underwent vitrification ultra-rapid cryopreservation till being transferred. Outcomes included the ability of PPOS to suppress the premature luteinizing hormone (LH) surge and prevent the development of ovarian hyperstimulation syndrome (OHSS), the incidence of profound LH suppression, the number of retrieved M2 oocyte and fertilization, chemical and clinical pregnancy rates, and the miscarriage rate.
- Conditions
- PCOS
- Being tested
- Injection of Cetrorelix, Oral insertion of dydrogeserone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of CetrorelixDrug
Patients received Cetrorelix subcutaneous injection on the day-6 in a dose of 0.25 daily till the trigger day.
Oral insertion of dydrogeseroneDrug
Patients received dydrogesterone in an oral dose of 20 mg/day in parallel with gonadotropin injection from day-2 of the menstrual cycle till the trigger day
| Study group | Role | What they receive |
|---|---|---|
| Group C | Active comparator | Not described Receives: Drug: Injection of Cetrorelix |
| Group S | Active comparator | Not described Receives: Drug: Oral insertion of dydrogeserone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of PPOS in relation to Premature LH surge suppression
the success rate of PPOS as regards the suppression of premature LH surge and prevention of the development of OHSS.
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 posted11 Jul 2023
- Study start1 Jun 2021
- Primary completion14 Sep 2022
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOSStudies 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
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Walid Mohamed Elnagar, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939284
- Sponsor's protocol ID
- ZU-IRB #10874-25/6-2023
- Status last verified
- Jul 2023
- First submitted
- 3 Jul 2023
- Last updated
- 11 Jul 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 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progesterone-Primed Ovarian Stimulation Might be a Safe and Effective Alternative to GnRH-antagonist Protocol for Controlled-Ovarian Stimulation of Infertile PCOS Women
- ClinicalTrials.gov ID
- NCT05939284
- Acronym / sponsor ID
- ZU-IRB #10874-25/6-2023
- Conditions
- PCOS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 14 Sep 2022 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 11 Jul 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.
The study evaluated the safety and efficacy of the progesterone-primed ovarian stimulation (PPOS) coupled with gonadotropin (FSH) for infertile women with polycystic ovary syndrome (PCOS) who were assigned for ICSI and frozen blastocyst transfer.
200 infertile women were divided randomly into Group C, which received Cetrorelix injection (0.25 mg daily) on day-6, and Group S, which received oral dydrogesterone (20 mg/day) on day-2 of the menstrual cycle till the trigger day. All patients received an FSH injection of 225 IU daily from day-2 till triggering day. ICSI was performed and day-5 blastocysts underwent vitrification ultra-rapid cryopreservation till being transferred. Outcomes included the ability of PPOS to suppress the premature luteinizing hormone (LH) surge and prevent the development of ovarian hyperstimulation syndrome (OHSS), the incidence of profound LH suppression, the number of retrieved M2 oocyte and fertilization, chemical and clinical pregnancy rates, and the miscarriage rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group C | Active comparator | Drug: Injection of Cetrorelix |
| Group S | Active comparator | Drug: Oral insertion of dydrogeserone |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Infertile PCOS women;
- aged 20-35 years;
- had BMI <35 kg/m2.
Key exclusion criteria (4 listed)
- Women who were younger than 20 or older than 35 years,
- obese of grade II or III,
- had poor OR, other causes of infertility,
- had previous attempts of IVF, had a history of repeated pregnancy loss.
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 |
|---|---|---|
| Injection of CetrorelixPatients received Cetrorelix subcutaneous injection on the day-6 in a dose of 0.25 daily till the trigger day. | Drug | Group C |
| Oral insertion of dydrogeseronePatients received dydrogesterone in an oral dose of 20 mg/day in parallel with gonadotropin injection from day-2 of the menstrual cycle till the trigger day | Drug | Group S |
Primary outcome
Success rate of PPOS in relation to Premature LH surge suppression
Time frame: 12 months
the success rate of PPOS as regards the suppression of premature LH surge and prevention of the development of OHSS.
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 Jul 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.
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 study testing Injection of Cetrorelix and Oral insertion of dydrogeserone in people with PCOS, 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 3 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 11 Jul 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?
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?
Success rate of PPOS in relation to Premature LH surge suppression (time frame: 12 months). 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 Jul 2023.