NCT04695483

Brief Summary

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2022

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

February 22, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2024

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

1.9 years

First QC Date

December 1, 2020

Last Update Submit

May 14, 2024

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Premature progesterone elevation

    Progesterone \> or equal to 1.1 ng/mL at day of trigger

    day 12

Secondary Outcomes (6)

  • Percentage of freeze-all cycles due to premature progesterone elevation

    day 12

  • Number of oocytes collected at ovum retrieval

    day 14

  • Fertilization rate

    day 15

  • Number of embryos available

    Day 17

  • Pregnancy rate

    day 30

  • +1 more secondary outcomes

Study Arms (2)

Corifollitropin alpha group

EXPERIMENTAL

Patients treated with Corifollitropin-alpha in a long-acting controlled ovarian stimulation

Drug: Corifollitropin alfaDrug: Follitropin Beta

FSH group

ACTIVE COMPARATOR

Patients treated with Follitropin beta in a daily controlled ovarian stimulation protocol

Drug: Follitropin Beta

Interventions

Corifollitropin alfaDRUG

Controlled ovarian stimulation long-acting protocol

Corifollitropin alpha group
Follitropin BetaDRUG

Daily controlled ovarian stimulation protocol

Corifollitropin alpha groupFSH group

Eligibility Criteria

Age25 Years - 42 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Freeze all cycles for abnormal bleeding
  • PCOS
  • History of untreated autoimmune
  • Endocrine or metabolic disorders
  • Ovarian cystectomy or oophorectomy
  • FSH ≥ 20 lU/L

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Enrico Papaleo

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Infertility

Interventions

follicle stimulating hormone, human, with HCG C-terminal peptidefollitropin beta

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Enrico Papaleo, MD

    IRCCS San Raffaele

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 1, 2020

First Posted

January 5, 2021

Study Start

February 22, 2022

Primary Completion

January 19, 2024

Study Completion

May 6, 2024

Last Updated

May 16, 2024

Record last verified: 2024-05

Locations

IT(1)