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

NCT ID: NCT04695483

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-22
• Study Completion Date: 2024-05-06

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.

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Corifollitropin alpha group

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

Group Type: EXPERIMENTAL

Corifollitropin alfa

Intervention Type: DRUG

Controlled ovarian stimulation long-acting protocol

Follitropin Beta

Intervention Type: DRUG

Daily controlled ovarian stimulation protocol

FSH group

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

Group Type: ACTIVE_COMPARATOR

Follitropin Beta

Intervention Type: DRUG

Daily controlled ovarian stimulation protocol

Interventions

Corifollitropin alfa

Controlled ovarian stimulation long-acting protocol

Intervention Type: DRUG

Follitropin Beta

Daily controlled ovarian stimulation protocol

Intervention Type: DRUG

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Enrico Papaleo

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enrico Papaleo, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS San Raffaele

Locations

Enrico Papaleo

Milan, , Italy

Countries

Italy

Other Identifiers

2020-004329-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PE-PMA

Identifier Type: -

Identifier Source: org_study_id