Clinical trial

Reduction of Progesterone Elevation at Trigger in Poor Responder Bologna' Criteria Patients After Controlled Ovarian Stimulation With Long Acting Standard Stimulation Protocol Compared With Conventional Daily Protocol: a Single Center Prospective Randomized Fase IV Trial

Name

PE-PMA

Description

The overarching objective of this research is to generate clinical evidence to argue the benefits of long acting stimulation protocol compared to the daily stimulation protocol in poor ovarian responder bologna' criteria patients after controlled ovarian stimulation. Reduction in the proportion of subjects with progesterone \> 1.1 ng/ml on the day of triggering (day + 13) in the experimental group compared to the control group is expected.

Trial arms

Trial start

2022-02-22

Estimated PCD

2024-01-19

Trial end

2024-05-06

Status

Completed

Phase

Early phase I

Treatment

Corifollitropin alfa

Controlled ovarian stimulation long-acting protocol

Arms:

Corifollitropin alpha group

Follitropin Beta

Daily controlled ovarian stimulation protocol

Arms:

Corifollitropin alpha group, FSH group

Size

110

Primary endpoint

Premature progesterone elevation

day 12

Eligibility criteria

Inclusion Criteria: * Indication to IVF treatment * Normal BMI (18.5-24.9 kg/m2) * AMH level \< 1.1 ng/ml and/or AFC \< 5 follicles and/or \< 3 oo-cytes retrieved in previous cycle * Regular menstrual cycles * Signed informed consent Exclusion Criteria: * Freeze all cycles for abnormal bleeding * PCOS * History of untreated autoimmune * Endocrine or metabolic disorders * Ovarian cystectomy or oophorectomy * FSH ≥ 20 lU/L

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 110, 'type': 'ACTUAL'}}

Updated at

2024-05-16

1 organization

2 products

1 indication

Organization

Product

Indication

Product