Double Pick up in Poor Prognosis Women

Study Overview
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Brief Summary
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The purpose of this randomized pilot study is to compare the efficacy of double oocyte retrieval vs. conventional antagonist ovarian stimulation protocol in poor prognosis patients undergoing IVF/ICSI.

Official Title
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Double Trigger and Ovum Retrieval vs. Conventional Antagonist Ovarian Stimulation Protocol in Poor Prognosis Women Undergoing IVF/ICSI: A Pilot Randomized Study

Conditions
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Fertility Disorders

Intervention / Treatment
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* Drug: CFA-double pick up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 25-40 years BMI ≤ 35 and ≥ 19 Antimüllerian hormone (AMH) level of ≤1.5 ng/mL or antral follicular count of ≤6 follicles or ≤5 oocytes retrieved in a previous cycle following standard conventional ovarian stimulation. Exclusion Criteria: Testicular sperm extraction History of > 3 three consecutive previous unsuccessful IVF cycles BMI >35 or <19 Use of oral contraceptives <3 months before start of the treatment PCOS according to the Rotterdam criteria Ovarian stimulation for pre-implantation genetic testing (PGT-A/M) Medical/social freezing In vitro maturation (IVM) History of untreated autoimmune, endocrine or metabolic disorders, Ovarian cystectomy or oophorectomy

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 40 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br> | |
| Experimental: double pick up group<br> | Drug: CFA-double pick up<br>* In the study group, 225 IU of rFSH will continue after the first oocyte retrieval (OR). Antagonist administration will be initiated when at least one follicle measuring ≥14 mm will be present in the ultrasound. If one or more follicles ≥17 mm are observed, patients will undergo a second triggering with hCG 5000 IU and a second OR will be performed. In case of patients with no follicular development following 10 additional days of rFSH post-OR<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of oocytes retrieved (metaphase II oocytes) between the two arms | number | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of preovulatory follicles |  | 1 month | 
| number of cumulus oocyte complexes (COCs) retrieved |  | 1 month | 
| number of oocytes fertilized |  | 1 month | 
| total number of available embryos |  | 1 month | 
| duration of ovarian stimulation |  | 1 month | 
| total dose of gonadotropins administered |  | 1 month | 
| clinical pregnancy rates |  | 4 months | 
| live birth rates |  | 12 months | 
| cumulative live birth rates | defined as the first live birth following the transfer of fresh and subsequent frozen-thawed embryos | 24 months |