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

I

Ibn Sina Hospital

Status

Terminated

Conditions

Infertility

Treatments

Drug: LH Suppression

Study type

Interventional

Funder types

Other

Identifiers

NCT04052607
IbnSina-PPOS

Details and patient eligibility

About

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.

Enrollment

56 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

56 participants in 3 patient groups

Dydrogesterone Suppression
Experimental group
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.
Treatment:
Drug: LH Suppression
Dydrogesterone Suppression with minimal stimulation
Experimental group
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.
Treatment:
Drug: LH Suppression
Antagonist Suppression
Active Comparator group
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.
Treatment:
Drug: LH Suppression

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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