Clinical trial NCT04052607: Progestin Priming Ovarian Stimulation (PPOS) Compared With Antagonist Protocol for Freeze-all Cycles
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
Overall status: TERMINATED
Phase: NA
Conditions: Infertility
Lead sponsor: Ibn Sina Hospital
Sponsor class: OTHER_GOV
First posted: 2019-08-12
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Live Birth after first Vitrified-warmed cycle
timeFrame: 42 weeks of gestation
Secondary outcomes:
measure: Biochemical pregnancy
timeFrame: 14 days after egg retrieval
measure: Clinical pregnancy
timeFrame: within 12 weeks of gestation
measure: Ongoing pregnancy
timeFrame: within 24 weeks of pregnancy
measure: Miscarriage
timeFrame: Within 20 weeks of pregnancy
measure: Term live-birth for vitrified-warmed transfer
timeFrame: Within 42 weeks of gestation
measure: Preterm Birth
timeFrame: Within 42 weeks of gestation
measure: Very preterm birth
timeFrame: Within 42 weeks of gestation
measure: Low birth weight babies
timeFrame: Within 24 hours of delivery
measure: Congenital malformation
timeFrame: Within one month of delivery
measure: Still birth
timeFrame: Within 42 weeks of gestation
measure: Cumulative live birth
timeFrame: One year from randomization
measure: Fertilization
timeFrame: Within 6 days of culture
measure: Embryo cleavage
timeFrame: Within 6 days of culture
measure: Top-quality embryo on day 3
timeFrame: Within 6 days of culture
measure: Blastocyst formation on day 5 or 6
timeFrame: Within 6 days of culture
measure: Top-quality blastocyst on day 5
timeFrame: Within 6 days of culture
measure: Cryopreservation
timeFrame: Within 6 days of culture
measure: Live-birth-implantation rate
timeFrame: Within 42 weeks of gestation
measure: Utilized embryos
timeFrame: Within 6 days of culture
measure: Top-quality utilized embryos
timeFrame: Within 6 days of culture
measure: Metaphase II oocyte
timeFrame: Within 24 hours of oocyte retrieval
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Banon Fertility Center
city: Sohag
country: Egypt
facility: IbnSina IVF Center, IbnSina Hospital
city: Sohag
country: Egypt
facility: AlRahma Hospital
Study officials:
affiliation: Ibnsina Hospital
name: Mohamed Fawzy
role: PRINCIPAL_INVESTIGATOR
References: