Clinical trial NCT03290911: Retrospective Trial on Low Prognosis Infertile Patients
Official title: An Observational Retrospective Cohort Trial on Low Prognosis Infertile Patient's Accessing IVF Cycle Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility, Female
Fertility Disorders
Keywords: low responders
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
Collaborators: name: Merck Serono International SA
First posted: 2017-09-25
Enrollment: 26883
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 26,883 consecutive fresh non-donors IVF cycles. Patients who underwent these cycles had consented in writing that their medical records could be used for research purposes, as long as the patients' anonymity was protected and confidentiality of the medical record was assured. Since both of these conditions were met, this study has been approved on March 2th 2017 with an expedited review and approval protocol by the center's Institutional Review Board (IRB).

At least 2,000 expected low prognosis patients in the Humanitas Fertility Center Database out of 12,545 cycles performed in the period 2010-2015 with completed pregnancy follow-up.

Brief summary: The main objective of this study is to analyze management of Controlled Ovarian Stimulation (COS) protocols in low prognosis patients, secondly to observe the clinical outcomes (Fertilization Rate, Pregnancy Rate, the Ongoing Pregnancy Rate and the Live birth Rate) and the total units of gonadotrophins consume per M2 oocyte retrieved in this subgroup.

Detailed description: Humanitas Fertility Center maintains an external audit anonymized electronic research queries system, exported from a certified only access web database, which at time of this analysis (cycles at December 31th 2016) include 26,883 consecutive fresh non-donors IVF cycles. Patients who underwent these cycles had consented in writing that their medical records could be used for research purposes, as long as the patients' anonymity was protected and confidentiality of the medical record was assured. Since both of these conditions were met, this study has been approved on March 2th 2017 with an expedited review and approval protocol by the center's Institutional Review Board (IRB).

At least 2,000 expected low prognosis patients in the Humanitas Fertility Center Database out of 12,545 cycles performed in the period 2010-2015 with completed pregnancy follow-up.

Eligibility criteria: Inclusion Criteria:

* Age ≤ 44
* Body Mass Index; 18 ≤ BMI ≥ 27
* Number of oocytes retrieved ≤ 9
* Cycles performed between January 2010 - December 2015

Exclusion Criteria:

* Age \> 44
* Number of oocytes retrieved ≥ 10
* Abnormal uterine cavity
* Endometriosis III-IV stage or adenomyosis
* Testicular spermatozoa PGS (Preimplantation Genetic Screening) cycles

Primary outcomes:
measure: induction protocol type
timeFrame: 6 years
Secondary outcomes:
measure: Fertilization Rate
timeFrame: 6 years
measure: Pregnancy Rate
timeFrame: 6 years
measure: Ongoing Pregnancy Rate
timeFrame: 6 years
measure: Live Birth Rate
timeFrame: 6 years
Other outcomes:
Locations:
Study officials:
References:
citation: Levi-Setti PE, Zerbetto I, Baggiani A, Zannoni E, Sacchi L, Smeraldi A, Morenghi E, De Cesare R, Drovanti A, Santi D. An Observational Retrospective Cohort Trial on 4,828 IVF Cycles Evaluating Different Low Prognosis Patients Following the POSEIDON Criteria. Front Endocrinol (Lausanne). 2019 May 8;10:282. doi: 10.3389/fendo.2019.00282. eCollection 2019.