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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Infertility

Intervention / Treatment
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* Drug: Corifollitropin alfa
* Drug: Follitropin Beta


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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