Clinical trial NCT04695483: Reduction of Progesterone Elevation at Trigger in POR After Long Acting COS Compared With Daily COS: a Prospective Randomized Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 110
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Premature progesterone elevation
timeFrame: day 12
Secondary outcomes:
measure: Percentage of freeze-all cycles due to premature progesterone elevation
timeFrame: day 12
measure: Number of oocytes collected at ovum retrieval
timeFrame: day 14
measure: Fertilization rate
timeFrame: day 15
measure: Number of embryos available
timeFrame: Day 17
measure: Pregnancy rate
timeFrame: day 30
measure: Ongoing pregnancy
timeFrame: Up to 20 weeks
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Enrico Papaleo
Study officials:
affiliation: IRCCS San Raffaele
name: Enrico Papaleo, MD
role: PRINCIPAL_INVESTIGATOR
References: