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

Infertility Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04052607
• Other study ID #: IbnSina-PPOS
• Status: Terminated
• Phase: N/A
• Start date: September 10, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: June 2022
• Source: Ibn Sina Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 56
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• LH Suppression
Stimulation protocols

Locations

Country	Name	City	State
Egypt	Banon Fertility Center	Assiut
Egypt	AlRahma Hospital	Sohag
Egypt	IbnSina IVF Center, IbnSina Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Ibn Sina Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

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