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

June 12, 2022 updated by: Muhammad Fawzy, Ibn Sina Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Women age of ≥ 18 to ≤ 40;
  2. BMI 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:

  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 malignancy or borderline pathology;
  8. Endometriosis;
  9. Plan for PGD-A;
  10. Severe male factor includes surgical sperm retrieval or cryopreserved sperm.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Stimulation protocols
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
Stimulation protocols
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
Stimulation protocols

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Live Birth after first Vitrified-warmed cycle
Time Frame: 42 weeks of gestation
Delivery of one or more viable infants > 20th weeks of gestation
42 weeks of gestation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Biochemical pregnancy
Time Frame: 14 days after egg retrieval
positive human chorionic Gonadotrophin (βhCG) ≥ 10 IU/L
14 days after egg retrieval
Clinical pregnancy
Time Frame: within 12 weeks of gestation
registered sacs with a heartbeat on ultrasound at 7th weeks of gestation
within 12 weeks of gestation
Ongoing pregnancy
Time Frame: within 24 weeks of pregnancy
continued viable pregnancy > 20th weeks of gestation
within 24 weeks of pregnancy
Miscarriage
Time Frame: Within 20 weeks of pregnancy
loss of pregnancy ≤ 20th weeks of gestation
Within 20 weeks of pregnancy
Term live-birth for vitrified-warmed transfer
Time Frame: Within 42 weeks of gestation
Delivery of one or more viable infants ≥37 weeks of gestation
Within 42 weeks of gestation
Preterm Birth
Time Frame: Within 42 weeks of gestation
delivery of one or more viable infants < 37th weeks of gestation
Within 42 weeks of gestation
Very preterm birth
Time Frame: Within 42 weeks of gestation
delivery of one or more viable infants < 32nd weeks of gestation
Within 42 weeks of gestation
Low birth weight babies
Time Frame: Within 24 hours of delivery
Babies with < 2500 gm
Within 24 hours of delivery
Congenital malformation
Time Frame: Within one month of delivery
delivery of congenitally malformed babies
Within one month of delivery
Still birth
Time Frame: Within 42 weeks of gestation
delivery of nonviable babies > 20 weeks of gestation
Within 42 weeks of gestation
Cumulative live birth
Time Frame: One year from randomization
Registered viable neonates after two vitrified-warmed transfers within one year of randomization
One year from randomization
Fertilization
Time Frame: Within 6 days of culture
presence of 2 pronuclei 17±1 hr after oocyte injection
Within 6 days of culture
Embryo cleavage
Time Frame: Within 6 days of culture
Cleaved embryos per fertilized oocyte
Within 6 days of culture
Top-quality embryo on day 3
Time Frame: Within 6 days of culture
(7-8 cells with appropriate-sizes blastomeres and less than 10% fragmentation by volume
Within 6 days of culture
Blastocyst formation on day 5 or 6
Time Frame: Within 6 days of culture
formed blastocysts per fertilized oocyte
Within 6 days of culture
Top-quality blastocyst on day 5
Time Frame: Within 6 days of culture
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
Within 6 days of culture
Cryopreservation
Time Frame: Within 6 days of culture
Cryopreserved embryos per fertilized oocyte
Within 6 days of culture
Live-birth-implantation rate
Time Frame: Within 42 weeks of gestation
Number of viable neonates per number of embryos transferred
Within 42 weeks of gestation
Utilized embryos
Time Frame: Within 6 days of culture
Number of cryopreserved plus transferred embryos per fertilized oocyte
Within 6 days of culture
Top-quality utilized embryos
Time Frame: Within 6 days of culture
Number of high-quality embryos transferred plus cryopreserved per fertilized oocyte
Within 6 days of culture
Metaphase II oocyte
Time Frame: Within 24 hours of oocyte retrieval
Mature oocyte per oocyte collected
Within 24 hours of oocyte retrieval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ibn Sina Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mohamed Fawzy, Ibnsina Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IbnSina-PPOS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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