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

Primary Purpose

Infertility

Status
Terminated
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
LH Suppression
Sponsored by
Ibn Sina Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Banon Fertility Center
  • IbnSina IVF Center, IbnSina Hospital
  • AlRahma Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Dydrogesterone Suppression

Dydrogesterone Suppression with minimal stimulation

Antagonist Suppression

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Live Birth after first Vitrified-warmed cycle
Delivery of one or more viable infants > 20th weeks of gestation

Secondary Outcome Measures

Biochemical pregnancy
positive human chorionic Gonadotrophin (βhCG) ≥ 10 IU/L
Clinical pregnancy
registered sacs with a heartbeat on ultrasound at 7th weeks of gestation
Ongoing pregnancy
continued viable pregnancy > 20th weeks of gestation
Miscarriage
loss of pregnancy ≤ 20th weeks of gestation
Term live-birth for vitrified-warmed transfer
Delivery of one or more viable infants ≥37 weeks of gestation
Preterm Birth
delivery of one or more viable infants < 37th weeks of gestation
Very preterm birth
delivery of one or more viable infants < 32nd weeks of gestation
Low birth weight babies
Babies with < 2500 gm
Congenital malformation
delivery of congenitally malformed babies
Still birth
delivery of nonviable babies > 20 weeks of gestation
Cumulative live birth
Registered viable neonates after two vitrified-warmed transfers within one year of randomization
Fertilization
presence of 2 pronuclei 17±1 hr after oocyte injection
Embryo cleavage
Cleaved embryos per fertilized oocyte
Top-quality embryo on day 3
(7-8 cells with appropriate-sizes blastomeres and less than 10% fragmentation by volume
Blastocyst formation on day 5 or 6
formed blastocysts per fertilized oocyte
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
Cryopreservation
Cryopreserved embryos per fertilized oocyte
Live-birth-implantation rate
Number of viable neonates per number of embryos transferred
Utilized embryos
Number of cryopreserved plus transferred embryos per fertilized oocyte
Top-quality utilized embryos
Number of high-quality embryos transferred plus cryopreserved per fertilized oocyte
Metaphase II oocyte
Mature oocyte per oocyte collected

Full Information

First Posted
August 8, 2019
Last Updated
June 12, 2022
Sponsor
Ibn Sina Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04052607
Brief Title
Progestin Priming Ovarian Stimulation (PPOS) Compared With Antagonist Protocol for Freeze-all Cycles
Acronym
ANTA-PPOS
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Due to COVID19 Pandemic effect on 2020.
Study Start Date
September 10, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ibn Sina Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dydrogesterone Suppression
Arm Type
Experimental
Arm Description
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.
Arm Title
Dydrogesterone Suppression with minimal stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Antagonist Suppression
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
LH Suppression
Intervention Description
Stimulation protocols
Primary Outcome Measure Information:
Title
Live Birth after first Vitrified-warmed cycle
Description
Delivery of one or more viable infants > 20th weeks of gestation
Time Frame
42 weeks of gestation
Secondary Outcome Measure Information:
Title
Biochemical pregnancy
Description
positive human chorionic Gonadotrophin (βhCG) ≥ 10 IU/L
Time Frame
14 days after egg retrieval
Title
Clinical pregnancy
Description
registered sacs with a heartbeat on ultrasound at 7th weeks of gestation
Time Frame
within 12 weeks of gestation
Title
Ongoing pregnancy
Description
continued viable pregnancy > 20th weeks of gestation
Time Frame
within 24 weeks of pregnancy
Title
Miscarriage
Description
loss of pregnancy ≤ 20th weeks of gestation
Time Frame
Within 20 weeks of pregnancy
Title
Term live-birth for vitrified-warmed transfer
Description
Delivery of one or more viable infants ≥37 weeks of gestation
Time Frame
Within 42 weeks of gestation
Title
Preterm Birth
Description
delivery of one or more viable infants < 37th weeks of gestation
Time Frame
Within 42 weeks of gestation
Title
Very preterm birth
Description
delivery of one or more viable infants < 32nd weeks of gestation
Time Frame
Within 42 weeks of gestation
Title
Low birth weight babies
Description
Babies with < 2500 gm
Time Frame
Within 24 hours of delivery
Title
Congenital malformation
Description
delivery of congenitally malformed babies
Time Frame
Within one month of delivery
Title
Still birth
Description
delivery of nonviable babies > 20 weeks of gestation
Time Frame
Within 42 weeks of gestation
Title
Cumulative live birth
Description
Registered viable neonates after two vitrified-warmed transfers within one year of randomization
Time Frame
One year from randomization
Title
Fertilization
Description
presence of 2 pronuclei 17±1 hr after oocyte injection
Time Frame
Within 6 days of culture
Title
Embryo cleavage
Description
Cleaved embryos per fertilized oocyte
Time Frame
Within 6 days of culture
Title
Top-quality embryo on day 3
Description
(7-8 cells with appropriate-sizes blastomeres and less than 10% fragmentation by volume
Time Frame
Within 6 days of culture
Title
Blastocyst formation on day 5 or 6
Description
formed blastocysts per fertilized oocyte
Time Frame
Within 6 days of culture
Title
Top-quality blastocyst on day 5
Description
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
Title
Cryopreservation
Description
Cryopreserved embryos per fertilized oocyte
Time Frame
Within 6 days of culture
Title
Live-birth-implantation rate
Description
Number of viable neonates per number of embryos transferred
Time Frame
Within 42 weeks of gestation
Title
Utilized embryos
Description
Number of cryopreserved plus transferred embryos per fertilized oocyte
Time Frame
Within 6 days of culture
Title
Top-quality utilized embryos
Description
Number of high-quality embryos transferred plus cryopreserved per fertilized oocyte
Time Frame
Within 6 days of culture
Title
Metaphase II oocyte
Description
Mature oocyte per oocyte collected
Time Frame
Within 24 hours of oocyte retrieval

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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); 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). Exclusion Criteria: 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; History of malignancy or borderline pathology; Endometriosis; Plan for PGD-A; Severe male factor includes surgical sperm retrieval or cryopreserved sperm.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Fawzy
Organizational Affiliation
Ibnsina Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banon Fertility Center
City
Assiut
Country
Egypt
Facility Name
IbnSina IVF Center, IbnSina Hospital
City
Sohag
ZIP/Postal Code
12345
Country
Egypt
Facility Name
AlRahma Hospital
City
Sohag
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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