InfertilityANTA-PPOSNCT04052607
Progestin Priming Ovarian Stimulation (PPOS) Compared With Antagonist Protocol for Freeze-all Cycles
A study testing LH Suppression in people with Infertility, run by Ibn Sina Hospital at 3 sites in Egypt.
Trial summary
Stimulation protocols for IVF underwent several cycles of upgrading aiming to achieve reasonable outcomes with low-cost cycles. Antagonist protocols have been introduced as effective and comparable to long agonist regarding the outcomes. However, these protocols are still costly. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- LH Suppression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 3 sitesEgypt
- Study dates
- 10 Sep 2019to 30 Apr 2020
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women age of ≥ 18 to ≤ 40;
- BMI of ≤ 31;
- All indication for freeze-all
- PCOS;
- Women who have ≥ 1 year of primary or secondary infertility;
- Tubal factor (unilateral, bilateral obstruction or salpingectomy);
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- Fresh ejaculate sperm of any count provided they have ≥ 1% normal forms and a motile fraction;
- Women undergoing their first ICSI cycle or following a previous successful attempt;
- Women undergoing only frozen-thawed embryo transfer;
- Women with > 8 mm endometrial thickness at the day of progesterone supplementation in the transfer cycle;
- Women with no detected uterine abnormality on transvaginal ultrasound (e.g. submucosal myomas, polyps or septa).
Who cannot join
- Unilateral oophorectomy;
- Uterine pathology or abnormality;
- Abnormal karyotyping for them or their male partners;
- History of repeated abortions or implantation failure;
- Uncontrolled diabetes;
- Liver or renal disease;
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- History of malignancy or borderline pathology;
- Endometriosis;
- Plan for PGD-A;
- Severe male factor includes surgical sperm retrieval or cryopreserved sperm.
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
Banon Fertility Center
Asyut
IbnSina IVF Center, IbnSina Hospital
Sohag, 12345
AlRahma Hospital
Sohag
About this study
Official title: Progestin Priming Ovarian Stimulation (PPOS) Compared With Antagonist Protocol on Live Birth Rate for Freeze-all Cycles: Recruitment is Slow Due to COVID19
Stimulation protocols for IVF underwent several cycles of upgrading aiming to achieve reasonable outcomes with low-cost cycles. Antagonist protocols have been introduced as effective and comparable to long agonist regarding the outcomes. However, these protocols are still costly. Alternative protocols using progestin suppressions appear options for consideration.
- Conditions
- Infertility
- Being tested
- LH Suppression
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LH SuppressionDrug
Stimulation protocols
| Study group | Role | What they receive |
|---|---|---|
| Dydrogesterone Suppression | Experimental | Dydrogesterone 30 mg on stimulation day 5 till the trigger day to prevent luteinizing hormone (LH) surge. The stimulation is with 150-300 IU FSH/HMG starting on cycle day 2 and adjusted according to the AFC and AMH. Receives: Drug: LH Suppression |
| Dydrogesterone Suppression with minimal stimulation | Experimental | Dydrogesterone 30 mg on stimulation day 5 till the trigger day to prevent LH surge. The stimulation is with clomifene citrate 50 mg three times daily with150 IU FSH starting on cycle day 2 and continued every other day and adjusted according to the AFC and AMH. Receives: Drug: LH Suppression |
| Antagonist Suppression | Active comparator | cetrorelix acetate 0.25 started on stimulation day 6 till the trigger day to prevent LH surge. The stimulation is with150-300 IU FSH starting on cycle day 2 and continued daily and adjusted according to the AFC and AMH. Receives: Drug: LH Suppression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live Birth after first Vitrified-warmed cycle
Delivery of one or more viable infants > 20th weeks of gestation
Measured: 42 weeks of gestation
Secondary outcomes (21)
Biochemical pregnancy
positive human chorionic Gonadotrophin (βhCG) ≥ 10 IU/L
Measured: 14 days after egg retrieval
Clinical pregnancy
registered sacs with a heartbeat on ultrasound at 7th weeks of gestation
Measured: within 12 weeks of gestation
Ongoing pregnancy
continued viable pregnancy > 20th weeks of gestation
Measured: within 24 weeks of pregnancy
Miscarriage
loss of pregnancy ≤ 20th weeks of gestation
Measured: Within 20 weeks of pregnancy
Term live-birth for vitrified-warmed transfer
Delivery of one or more viable infants ≥37 weeks of gestation
Measured: Within 42 weeks of gestation
Preterm Birth
delivery of one or more viable infants < 37th weeks of gestation
Measured: Within 42 weeks of gestation
Very preterm birth
delivery of one or more viable infants < 32nd weeks of gestation
Measured: Within 42 weeks of gestation
Low birth weight babies
Babies with < 2500 gm
Measured: Within 24 hours of delivery
Congenital malformation
delivery of congenitally malformed babies
Measured: Within one month of delivery
Still birth
delivery of nonviable babies > 20 weeks of gestation
Measured: Within 42 weeks of gestation
Cumulative live birth
Registered viable neonates after two vitrified-warmed transfers within one year of randomization
Measured: One year from randomization
Fertilization
presence of 2 pronuclei 17±1 hr after oocyte injection
Measured: Within 6 days of culture
Embryo cleavage
Cleaved embryos per fertilized oocyte
Measured: Within 6 days of culture
Top-quality embryo on day 3
(7-8 cells with appropriate-sizes blastomeres and less than 10% fragmentation by volume
Measured: Within 6 days of culture
Blastocyst formation on day 5 or 6
formed blastocysts per fertilized oocyte
Measured: Within 6 days of culture
Top-quality blastocyst on day 5
Rounded and dense inner cell mass with many trophectodermal cells creating a connected zone and a blastocoel more than 100% by volume; ≥ 311 grade per fertilized oocyte
Measured: Within 6 days of culture
Cryopreservation
Cryopreserved embryos per fertilized oocyte
Measured: Within 6 days of culture
Live-birth-implantation rate
Number of viable neonates per number of embryos transferred
Measured: Within 42 weeks of gestation
Utilized embryos
Number of cryopreserved plus transferred embryos per fertilized oocyte
Measured: Within 6 days of culture
Top-quality utilized embryos
Number of high-quality embryos transferred plus cryopreserved per fertilized oocyte
Measured: Within 6 days of culture
Metaphase II oocyte
Mature oocyte per oocyte collected
Measured: Within 24 hours of oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start10 Sep 2019
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Why it stopped: Due to COVID19 Pandemic effect on 2020.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ibn Sina Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammad Fawzy, Ibn Sina Hospital
- Investigators
- Mohamed Fawzy, Principal investigator, Ibnsina Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052607
- Sponsor's protocol ID
- IbnSina-PPOS
- Acronym
- ANTA-PPOS
- Status last verified
- Jun 2022
- First submitted
- 8 Aug 2019
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progestin Priming Ovarian Stimulation (PPOS) Compared With Antagonist Protocol on Live Birth Rate for Freeze-all Cycles: Recruitment is Slow Due to COVID19
- ClinicalTrials.gov ID
- NCT04052607
- Acronym / sponsor ID
- ANTA-PPOS / IbnSina-PPOS
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to COVID19 Pandemic effect on 2020.
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ibn Sina HospitalOther government
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 12 Aug 2019 (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.
Stimulation protocols for IVF underwent several cycles of upgrading aiming to achieve reasonable outcomes with low-cost cycles. Antagonist protocols have been introduced as effective and comparable to long agonist regarding the outcomes. However, these protocols are still costly. Alternative protocols using progestin suppressions appear options for consideration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dydrogesterone Suppression | Experimental | Drug: LH SuppressionDydrogesterone 30 mg on stimulation day 5 till the trigger day to prevent luteinizing hormone (LH) surge. The stimulation is with 150-300 IU FSH/HMG starting on cycle day 2 and adjusted according to the AFC and AMH. |
| Dydrogesterone Suppression with minimal stimulation | Experimental | Drug: LH SuppressionDydrogesterone 30 mg on stimulation day 5 till the trigger day to prevent LH surge. The stimulation is with clomifene citrate 50 mg three times daily with150 IU FSH starting on cycle day 2 and continued every other day and adjusted according to the AFC and AMH. |
| Antagonist Suppression | Active comparator | Drug: LH Suppressioncetrorelix acetate 0.25 started on stimulation day 6 till the trigger day to prevent LH surge. The stimulation is with150-300 IU FSH starting on cycle day 2 and continued daily and adjusted according to the AFC and AMH. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Women age of ≥ 18 to ≤ 40;
- BMI of ≤ 31;
- All indication for freeze-all
- PCOS;
- Women who have ≥ 1 year of primary or secondary infertility;
Key exclusion criteria (10 listed)
- Unilateral oophorectomy;
- Uterine pathology or abnormality;
- Abnormal karyotyping for them or their male partners;
- History of repeated abortions or implantation failure;
- Uncontrolled diabetes;
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 |
|---|---|---|
| LH SuppressionStimulation protocols | Drug | Antagonist Suppression, Dydrogesterone Suppression, Dydrogesterone Suppression with minimal stimulation |
Primary outcome
Live Birth after first Vitrified-warmed cycle
Time frame: 42 weeks of gestation
Delivery of one or more viable infants > 20th weeks of gestation
21 secondary outcomes
Biochemical pregnancy
Time frame: 14 days after egg retrieval
Clinical pregnancy
Time frame: within 12 weeks of gestation
Ongoing pregnancy
Time frame: within 24 weeks of pregnancy
Miscarriage
Time frame: Within 20 weeks of pregnancy
Term live-birth for vitrified-warmed transfer
Time frame: Within 42 weeks of gestation
Preterm Birth
Time frame: Within 42 weeks of gestation
Very preterm birth
Time frame: Within 42 weeks of gestation
Low birth weight babies
Time frame: Within 24 hours of delivery
Congenital malformation
Time frame: Within one month of delivery
Still birth
Time frame: Within 42 weeks of gestation
Cumulative live birth
Time frame: One year from randomization
Fertilization
Time frame: Within 6 days of culture
Embryo cleavage
Time frame: Within 6 days of culture
Top-quality embryo on day 3
Time frame: Within 6 days of culture
Blastocyst formation on day 5 or 6
Time frame: Within 6 days of culture
Top-quality blastocyst on day 5
Time frame: Within 6 days of culture
Cryopreservation
Time frame: Within 6 days of culture
Live-birth-implantation rate
Time frame: Within 42 weeks of gestation
Utilized embryos
Time frame: Within 6 days of culture
Top-quality utilized embryos
Time frame: Within 6 days of culture
Metaphase II oocyte
Time frame: Within 24 hours of oocyte retrieval
Results and safety
The study was stopped early (reason given: Due to COVID19 Pandemic effect on 2020.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Mohamed Fawzy principal investigator
Ibnsina Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LH Suppression in people with Infertility, run by Ibn Sina Hospital at 3 sites 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 11 inclusion and 10 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: stopped early, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 was stopped early (reason given: Due to COVID19 Pandemic effect on 2020.). Results are not available in the source record.
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?
Live Birth after first Vitrified-warmed cycle (time frame: 42 weeks of gestation). 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 15 Jun 2022.