Reduction of Progesterone Elevation at Trigger in POR After Long Acting COS Compared With Daily COS: a Prospective Randomized Trial (PE-PMA)

May 14, 2024 updated by: Enrico Papaleo, IRCCS San Raffaele

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Each patient will receive a first visit for infertility where will be collected subject history and baseline information, and meet all the inclusion / exclusion criteria. Eligible patients who agreed to participate will be randomized to either long acting standard COS with corifollitropin alpha or standard COS with daily FSH in a fixed GnRH antagonist protocol. All patients will be allowed to participate in the study only once and a written informed consent will be obtained from all, following consultation and before the initiation of the treatment.

The endocrine profile of all the patients will be evaluated by analysis of serum progesterone, 17b-estradiol (E2), FSH and LH at different time points: basal condition, during stimulation, at the hCG day and at pick-up.

Transvaginal follicular aspiration will be performed by ultrasound guidance 36 hours after hCG administration. The day of pick up oocytes will be fertilized with partner's semen; after 3-5 days, on the base of its evolution, embryo will be transferred. 14 days after embryo-transfer a preg-nancy test will be performed. Follow up in case of obtained pregnancy will be done until 20 weeks of gestation and considered as ongoing pregnancy.

The entire duration of the study is 24 months, the follow up of the last patients enrolled will be 6 months.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20132
        • Enrico Papaleo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Corifollitropin alpha group
Patients treated with Corifollitropin-alpha in a long-acting controlled ovarian stimulation
Drug: Corifollitropin alfa
Controlled ovarian stimulation long-acting protocol
Drug: Follitropin Beta
Daily controlled ovarian stimulation protocol
Active Comparator: FSH group
Patients treated with Follitropin beta in a daily controlled ovarian stimulation protocol
Drug: Follitropin Beta
Daily controlled ovarian stimulation protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Premature progesterone elevation
Time Frame: day 12
Progesterone > or equal to 1.1 ng/mL at day of trigger
day 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of freeze-all cycles due to premature progesterone elevation
Time Frame: day 12
day 12
Number of oocytes collected at ovum retrieval
Time Frame: day 14
day 14
Fertilization rate
Time Frame: day 15
Percentage of oocytes fertilized
day 15
Number of embryos available
Time Frame: Day 17
Day 17
Pregnancy rate
Time Frame: day 30
Beta-HCG positive
day 30
Ongoing pregnancy
Time Frame: Up to 20 weeks
Vital fetus at 20 weeks of gestation
Up to 20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Investigators

  • Principal Investigator: ENRICO PAPALEO, MD, IRCCS San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2022

Primary Completion (Actual)

January 19, 2024

Study Completion (Actual)

May 6, 2024

Study Registration Dates

First Submitted

December 1, 2020

First Submitted That Met QC Criteria

January 3, 2021

First Posted (Actual)

January 5, 2021

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 14, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PE-PMA
  • 2020-004329-21 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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