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

Infertility Clinical Trial

— PE-PMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04695483
• Other study ID #: PE-PMA
• Secondary ID: 2020-004329-21
• Status: Completed
• Phase: Phase 4
• Start date: February 22, 2022
• Est. completion date: May 6, 2024

Study information

• Verified date: May 2024
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 6, 2024
• Est. primary completion date: January 19, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Corifollitropin alfa
Controlled ovarian stimulation long-acting protocol
• Follitropin Beta
Daily controlled ovarian stimulation protocol

Locations

Country	Name	City	State
Italy	Enrico Papaleo	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Premature progesterone elevation	Progesterone > or equal to 1.1 ng/mL at day of trigger	day 12
Secondary	Percentage of freeze-all cycles due to premature progesterone elevation		day 12
Secondary	Number of oocytes collected at ovum retrieval		day 14
Secondary	Fertilization rate	Percentage of oocytes fertilized	day 15
Secondary	Number of embryos available		Day 17
Secondary	Pregnancy rate	Beta-HCG positive	day 30
Secondary	Ongoing pregnancy	Vital fetus at 20 weeks of gestation	Up to 20 weeks