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

Ibn Sina Hospital56 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Infertility

Interventions

LH SuppressionDRUG

Stimulation protocols

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (3)

Banon Fertility Center

Asyut, Egypt

IbnSina IVF Center, IbnSina Hospital

Sohag, Egypt

AlRahma Hospital

Sohag, Egypt

Outcomes

Primary Outcomes

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

Biochemical pregnancy

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

Time frame: 14 days after egg retrieval

Clinical pregnancy

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

Time frame: within 12 weeks of gestation

Ongoing pregnancy

continued viable pregnancy \> 20th weeks of gestation

Time frame: within 24 weeks of pregnancy

Miscarriage

loss of pregnancy ≤ 20th weeks of gestation

Time frame: Within 20 weeks of pregnancy

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

Preterm Birth

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

Time frame: Within 42 weeks of gestation

Very preterm birth

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

Time frame: Within 42 weeks of gestation

Data from ClinicalTrials.gov

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