ClinicalTrials.gg
TerminatedNCT04052607ANTA-PPOSUpdated Jun 15, 2022

Progestin Priming Ovarian Stimulation (PPOS) Compared With Antagonist Protocol for Freeze-all Cycles

An interventional study of LH Suppression in Infertility, sponsored by Ibn Sina Hospital. Terminated at 3 sites in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2022-06-15.

Sponsored by Ibn Sina Hospital · Not applicable, Interventional, and Treatment

Why this study was terminated
Due to COVID19 Pandemic effect on 2020.
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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. Alternative protocols using progestin suppressions appear options for consideration.

02

Conditions studied

  • Infertility

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03

In context

Infertility

2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.

This study's enrollment of 56 is below the median of 135 across 1,412 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Ibn Sina Hospital is the lead sponsor of 28 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Women age of ≥ 18 to ≤ 40;
  2. of ≤ 31;
  3. All indication for freeze-all
  4. PCOS;
  5. Women who have ≥ 1 year of primary or secondary infertility;
  6. Tubal factor (unilateral, bilateral obstruction or salpingectomy);
  7. Fresh ejaculate sperm of any count provided they have ≥ 1% normal forms and a motile fraction;
  8. Women undergoing their first ICSI cycle or following a previous successful attempt;
  9. Women undergoing only frozen-thawed embryo transfer;
  10. Women with > 8 mm endometrial thickness at the day of progesterone supplementation in the transfer cycle;
  11. Women with no detected uterine abnormality on transvaginal ultrasound (e.g. submucosal myomas, polyps or septa).

Exclusion criteria

Exclusion Criteria:

  1. Unilateral oophorectomy;
  2. Uterine pathology or abnormality;
  3. Abnormal karyotyping for them or their male partners;
  4. History of repeated abortions or implantation failure;
  5. Uncontrolled diabetes;
  6. Liver or renal disease;
  7. History of or borderline pathology;
  8. Endometriosis;
  9. Plan for PGD-A;
  10. Severe male factor includes surgical sperm retrieval or cryopreserved sperm.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    Dydrogesterone Suppression

    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.

    Drug: LH Suppression

  • Experimental
    Dydrogesterone Suppression with minimal stimulation

    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.

    Drug: LH Suppression

  • Active comparator
    Antagonist Suppression

    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.

    Drug: LH Suppression

Interventions

  • DrugLH Suppression

    Stimulation protocols

06

What researchers measure

Primary outcomes

  1. Live Birth after first Vitrified-warmed cycle

    Delivery of one or more viable infants \> 20th weeks of gestation

    Time frame: 42 weeks of gestation

Secondary outcomes

  1. Biochemical pregnancy

    positive human chorionic Gonadotrophin (βhCG) ≥ 10 IU/L

    Time frame: 14 days after egg retrieval

  2. Clinical pregnancy

    registered sacs with a heartbeat on ultrasound at 7th weeks of gestation

    Time frame: within 12 weeks of gestation

  3. Ongoing pregnancy

    continued viable pregnancy \> 20th weeks of gestation

    Time frame: within 24 weeks of pregnancy

  4. Miscarriage

    loss of pregnancy ≤ 20th weeks of gestation

    Time frame: Within 20 weeks of pregnancy

  5. Term live-birth for vitrified-warmed transfer

    Delivery of one or more viable infants ≥37 weeks of gestation

    Time frame: Within 42 weeks of gestation

  6. Preterm Birth

    delivery of one or more viable infants \< 37th weeks of gestation

    Time frame: Within 42 weeks of gestation

  7. Very preterm birth

    delivery of one or more viable infants \< 32nd weeks of gestation

    Time frame: Within 42 weeks of gestation

  8. Low birth weight babies

    Babies with \< 2500 gm

    Time frame: Within 24 hours of delivery

  9. Congenital malformation

    delivery of congenitally malformed babies

    Time frame: Within one month of delivery

  10. Still birth

    delivery of nonviable babies \> 20 weeks of gestation

    Time frame: Within 42 weeks of gestation

  11. Cumulative live birth

    Registered viable neonates after two vitrified-warmed transfers within one year of randomization

    Time frame: One year from randomization

  12. Fertilization

    presence of 2 pronuclei 17±1 hr after oocyte injection

    Time frame: Within 6 days of culture

  13. Embryo cleavage

    Cleaved embryos per fertilized oocyte

    Time frame: Within 6 days of culture

  14. Top-quality embryo on day 3

    (7-8 cells with appropriate-sizes blastomeres and less than 10% fragmentation by volume

    Time frame: Within 6 days of culture

  15. Blastocyst formation on day 5 or 6

    formed blastocysts per fertilized oocyte

    Time frame: Within 6 days of culture

  16. 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

    Time frame: Within 6 days of culture

  17. Cryopreservation

    Cryopreserved embryos per fertilized oocyte

    Time frame: Within 6 days of culture

  18. Live-birth-implantation rate

    Number of viable neonates per number of embryos transferred

    Time frame: Within 42 weeks of gestation

  19. Utilized embryos

    Number of cryopreserved plus transferred embryos per fertilized oocyte

    Time frame: Within 6 days of culture

  20. Top-quality utilized embryos

    Number of high-quality embryos transferred plus cryopreserved per fertilized oocyte

    Time frame: Within 6 days of culture

  21. Metaphase II oocyte

    Mature oocyte per oocyte collected

    Time frame: Within 24 hours of oocyte retrieval

07

Study locations

3 sites
  • Banon Fertility Center
    Assiut, Egypt
  • IbnSina IVF Center, IbnSina Hospital
    Sohag, 12345, Egypt
  • AlRahma Hospital
    Sohag, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2019 to primary completion in Apr 2020, 7 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 8, 2019
First posted
Aug 12, 2019
StartActual
Sep 10, 2019
Primary completionActual
Apr 30, 2020
CompletionActual
Apr 30, 2020
Last update
Jun 15, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04052607
Lead sponsor
Ibn Sina Hospital
Responsible party
Muhammad Fawzy (IVF Lab Director, Ibn Sina Hospital) — Principal investigator
First posted
Aug 12, 2019
Start date
Sep 10, 2019
Primary completion
Apr 30, 2020
Completion
Apr 30, 2020
Last update
Jun 15, 2022

Study contacts

Mohamed Fawzy
principal investigator · Ibnsina Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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