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OpenTrials
Completed

NCT Number: NCT03290911

Retrospective Trial on Low Prognosis Infertile Patients

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.

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Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fertility Disorders Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Age range

18 year–44 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. induction protocol type

    Time frame: 6 years

    number of antagonist and agonist protocols/ total numbers

Secondary outcomes

  1. Fertilization Rate

    Time frame: 6 years

    fertilized oocytes/ number of oocytes used

  2. Pregnancy Rate

    Time frame: 6 years

    number of gestational sacs/ number of embryos transferred

  3. Ongoing Pregnancy Rate

    Time frame: 6 years

    number of pregnancy > 20 weeks/ total pregnancies

  4. Live Birth Rate

    Time frame: 6 years

    number babies born/ total pregnancies

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Collaborators

  • Merck Serono International SA

Registry information

Official study title

An Observational Retrospective Cohort Trial on Low Prognosis Infertile Patient's Accessing IVF Cycle Management

Important dates

Study start
2010
Primary completion
2015
Study completion
2017
First posted
Sep 25, 2017
Registry last updated
Sep 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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