IVFPhase 4NCT06396390
Comparison of Progestin Primed Ovarian Stimulation (PPOS) vs.GnRH Antagonist Methods on IVF Outcomes
A Phase 4 study testing Progestin and GnRH antagonist in people with IVF and Fertility Issues, run by Nesta Clinic at 1 site in Turkey (Türkiye).
Trial summary
The goal of this randomized clinical trial is to compare the effects of two different ovarian stimulation methods: Progestin Primed Ovarian Stimulation (PPOS) vs. GnRH Antagonist in embryologic outcomes of IVF Patients. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- IVF, Fertility Issues, Infertility
- What is being tested?
- Progestin and GnRH antagonist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 1 Aug 2026
- Phase
- Phase 4
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI > 18 kg/m2 ve <35 kg/m2
- Couples that accept being included in the study
- Couple accepting thawed embryo transfer
Who cannot join
- Known chromosomal abnormality in either member of the couple
- Couples with unexplained infertility
- BMI > 30 kg/m2
- Mullerian malformations
- Undergoing oocyte cryopreservation for medical reasons (such as malignancies)
- Couple insists on fresh embryo transfer
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Nesta Clinic
Istanbul, Sisli, 34349
Zuhal Yucel, B.N., +90 542 125 29 99, zuhal.yucel@nestaclinic.com
Seyma Aydiner, B.B.A, +90 212 219 99 29, seyma.aydiner@nestaclinic.com
About this study
Official title: The Comparative Results of Progestin Primed Ovarian Stimulation (PPOS) and GnRH Antagonist Ovarian Stimulation Methods on IVF Outcomes
The goal of this randomized clinical trial is to compare the effects of two different ovarian stimulation methods: Progestin Primed Ovarian Stimulation (PPOS) vs. GnRH Antagonist in embryologic outcomes of IVF Patients.
Read the detailed description
The goal of this randomized clinical trial is to compare the effects of two different ovarian stimulation methods: Progestin Primed Ovarian Stimulation (PPOS) vs. GnRH Antagonist in embryologic outcomes of IVF Patients.
Ovarian stimulation will be conducted according to the assigned arm protocol.
Both artificially prepared and modified natural cycles will be eligible to be included and the choice will be done according to the doctor's preference and the patient's menstrual cycle regularity.
- For artificially prepared transfers, Estradiol Hemihydrate (Estrofem©, 2mg, Novo Nordisk, Malov/Denmark) 3x1 PO will be started on the day 2 of the menstrual cycle. After 12-14 days of usage, in order not to cancel the cycle, endometrial thickness needs measured at least 7mm and serum progesterone level < 1.5 ng/mL.
- For luteal support in addition to Progesterone (Progestan Dex©, 25mg, Kocak Farma İlaç ve Kimya Sanayi A.Ş., Istanbul, Turkiye) 2x1 SC once, with a 12-hour interval at day 14 of the menstrual cycle; Progesterone (Progestan©, 200mg, Kocak Farma İlaç ve Kimya Sanayi A.Ş., Istanbul, Turkiye) 2x1 PV will be started and continued for 5 days. Embryo transfer will be performed at 6th day. Estradiol Hemihydrate will be stopped on week 2 and progesterone support will be continued until the 8th week of gestation.
- Conditions
- IVF, Fertility Issues, Infertility
- Being tested
- Progestin, GnRH antagonist
- Keywords
- GnRH Antagonist, Progestin Primed Ovarian Stimulation, Infertility, Ovarian Stimulation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgestinDrug
Also called Progestin Primed Ovarian Stimulation Protocol
In this regimen, Dydrogesterone (Duphaston©; 10mg; Deva Holding, Tekirdag/Turkiye) 3x1 PO will be started on day 2 of menstrual cycle and will be continued until the trigger day. The patient's dosage will be tailored based on their BMI, AMH value, and the number of follicles observed during the ultrasound examination on the 2nd day of the menstrual cycle. For triggering, Choriogonadotropin-α (Ovitrelle©, 250 mcg/0.5 mL, Merck Serono S.p.A., Bari/Italy) 1 amp SC + Triptorelin Acetate (Gonapeptyl©, 0.1mg/mL, Ferring GmbH, Kiel/Germany) 2 amp SC will be used. All oocytes picked-up will be frozen.
GnRH antagonistDrug
Also called GnRH Antagonist Ovarian Stimulation Protocol
In this regimen, Cetrorelix (Cetrotide©, 250 mcg/mL, Pierre Fabre Medicament Production, Idron, France) 1x1 SC will be started on day 7 of menstrual cycle and will be continued until the trigger day. For triggering, Choriogonadotropin-α (Ovitrelle©, 250 mcg/0.5 mL, Merck Serono S.p.A., Bari/Italy) 1 amp SC + Triptorelin Acetate (Gonapeptyl©, 0.1mg/mL, Ferring GmbH, Kiel/Germany) 2 amp SC will be used. All oocytes picked-up will be frozen.
| Study group | Role | What they receive |
|---|---|---|
| Progestin Primed Ovarian Stimulation (PPOS) | Experimental | In this patient group, progestin based protocol is going to be the main course of treatment. Receives: Drug: Progestin |
| GnRH Antagonist Stimulation | Active comparator | In this patient group, GnRH Antagonist treatment protocol is going to be the main course of treatment. Receives: Drug: GnRH antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blastulation Rate
number of blastocysts up to day 6 / the number of fertilized 2PN embryos
Measured: Day 5 or 6 after fertilization
Secondary outcomes (4)
PGT Results
Euploidy and aneuploidy rates
Measured: 14 days after blastocyte culture sampling
Ongoing pregnancy
Fetal heart rate examination via USG
Measured: on gestational week 12
Live Birth Rate
For pregnancies resulted within the study period, live birth/embryo transfer count
Measured: 9 months
Chemical Pregnancy
Serum ß-hcg level
Measured: on day 11 after transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nesta Clinic
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Emre Kar, Nesta Clinic
- Investigators
- Ercan Bastu, M.D., Study director, Owner
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396390
- Sponsor's protocol ID
- 2024001
- Status last verified
- Jul 2024
- First submitted
- 29 Apr 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be available upon request for at least 2 years after publication.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Results of Progestin Primed Ovarian Stimulation (PPOS) and GnRH Antagonist Ovarian Stimulation Methods on IVF Outcomes
- ClinicalTrials.gov ID
- NCT06396390
- Acronym / sponsor ID
- 2024001
- Conditions
- IVF, Fertility Issues, Infertility
- Keywords
- GnRH Antagonist, Progestin Primed Ovarian Stimulation, Infertility, Ovarian Stimulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Nesta ClinicResearch network
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 2 May 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 randomized clinical trial is to compare the effects of two different ovarian stimulation methods: Progestin Primed Ovarian Stimulation (PPOS) vs. GnRH Antagonist in embryologic outcomes of IVF Patients.
Detailed description
The goal of this randomized clinical trial is to compare the effects of two different ovarian stimulation methods: Progestin Primed Ovarian Stimulation (PPOS) vs. GnRH Antagonist in embryologic outcomes of IVF Patients.
Ovarian stimulation will be conducted according to the assigned arm protocol.
Both artificially prepared and modified natural cycles will be eligible to be included and the choice will be done according to the doctor's preference and the patient's menstrual cycle regularity.
- For artificially prepared transfers, Estradiol Hemihydrate (Estrofem©, 2mg, Novo Nordisk, Malov/Denmark) 3x1 PO will be started on the day 2 of the menstrual cycle. After 12-14 days of usage, in order not to cancel the cycle, endometrial thickness needs measured at least 7mm and serum progesterone level < 1.5 ng/mL.
- For luteal support in addition to Progesterone (Progestan Dex©, 25mg, Kocak Farma İlaç ve Kimya Sanayi A.Ş., Istanbul, Turkiye) 2x1 SC once, with a 12-hour interval at day 14 of the menstrual cycle; Progesterone (Progestan©, 200mg, Kocak Farma İlaç ve Kimya Sanayi A.Ş., Istanbul, Turkiye) 2x1 PV will be started and continued for 5 days. Embryo transfer will be performed at 6th day. Estradiol Hemihydrate will be stopped on week 2 and progesterone support will be continued until the 8th week of gestation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progestin Primed Ovarian Stimulation (PPOS) | Experimental | Drug: ProgestinIn this patient group, progestin based protocol is going to be the main course of treatment. |
| GnRH Antagonist Stimulation | Active comparator | Drug: GnRH antagonistIn this patient group, GnRH Antagonist treatment protocol is going to be the main course of treatment. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI > 18 kg/m2 ve <35 kg/m2
- Couples that accept being included in the study
- Couple accepting thawed embryo transfer
Key exclusion criteria (6 listed)
- Known chromosomal abnormality in either member of the couple
- Couples with unexplained infertility
- BMI > 30 kg/m2
- Mullerian malformations
- Undergoing oocyte cryopreservation for medical reasons (such as malignancies)
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 |
|---|---|---|
| ProgestinAlso: Progestin Primed Ovarian Stimulation ProtocolIn this regimen, Dydrogesterone (Duphaston©; 10mg; Deva Holding, Tekirdag/Turkiye) 3x1 PO will be started on day 2 of menstrual cycle and will be continued until the trigger day. The patient's dosage will be tailored based on their BMI, AMH value, and the number of follicles observed during the ultrasound examination on the 2nd day of the menstrual cycle. For triggering, Choriogonadotropin-α (Ovitrelle©, 250 mcg/0.5 mL, Merck Serono S.p.A., Bari/Italy) 1 amp SC + Triptorelin Acetate (Gonapeptyl©, 0.1mg/mL, Ferring GmbH, Kiel/Germany) 2 amp SC will be used. All oocytes picked-up will be frozen. | Drug | Progestin Primed Ovarian Stimulation (PPOS) |
| GnRH antagonistAlso: GnRH Antagonist Ovarian Stimulation ProtocolIn this regimen, Cetrorelix (Cetrotide©, 250 mcg/mL, Pierre Fabre Medicament Production, Idron, France) 1x1 SC will be started on day 7 of menstrual cycle and will be continued until the trigger day. For triggering, Choriogonadotropin-α (Ovitrelle©, 250 mcg/0.5 mL, Merck Serono S.p.A., Bari/Italy) 1 amp SC + Triptorelin Acetate (Gonapeptyl©, 0.1mg/mL, Ferring GmbH, Kiel/Germany) 2 amp SC will be used. All oocytes picked-up will be frozen. | Drug | GnRH Antagonist Stimulation |
Primary outcome
Blastulation Rate
Time frame: Day 5 or 6 after fertilization
number of blastocysts up to day 6 / the number of fertilized 2PN embryos
4 secondary outcomes
PGT Results
Time frame: 14 days after blastocyte culture sampling
Ongoing pregnancy
Time frame: on gestational week 12
Live Birth Rate
Time frame: 9 months
Chemical Pregnancy
Time frame: on day 11 after transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: Yes. IPD will be available upon request for at least 2 years after publication.
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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.
Ercan Bastu, M.D. study director
Owner
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Progestin and GnRH antagonist in people with IVF and Fertility Issues, run by Nesta Clinic at 1 site in Turkey (Türkiye).
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 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: status not confirmed, as of the sponsor's last update on 17 Jul 2024. 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 Turkey (Türkiye). 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zuhal Yucel, B.N. (+90 542 125 29 99, zuhal.yucel@nestaclinic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blastulation Rate (time frame: Day 5 or 6 after fertilization). 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 17 Jul 2024.