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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-10

Study Completion Date

2020-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Dydrogesterone Suppression

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.

Group Type EXPERIMENTAL

LH Suppression

Intervention Type DRUG

Stimulation protocols

Dydrogesterone Suppression with minimal stimulation

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.

Group Type EXPERIMENTAL

LH Suppression

Intervention Type DRUG

Stimulation protocols

Antagonist Suppression

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.

Group Type ACTIVE_COMPARATOR

LH Suppression

Intervention Type DRUG

Stimulation protocols

Interventions

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LH Suppression

Stimulation protocols

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No