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Trial record 3 of 444 for:    Recruiting, Not yet recruiting Studies | Infertility

In Vitro Fertilisation Versus Intracytoplasmic Sperm Injection in Patients Without Severe Male Factor Infertility (INVICSI)

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ClinicalTrials.gov Identifier: NCT04128904
Recruitment Status : Recruiting
First Posted : October 16, 2019
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Nina la Cour Freiesleben, Copenhagen University Hospital, Hvidovre

Brief Summary:

Over recent decades, the use of intracytoplasmic sperm injection (ICSI) has increased, even among patients without severe male factor infertility. Despite the increasing use, there is no evidence to support that ICSI results in a higher live birth rate compared to conventional in vitro fertilisation (IVF) in cases without severe male factor infertility. The primary objective of this trial is to determine whether ICSI is superior to standard IVF in patients without severe male factor infertility. The primary outcome measure is live birth rate.

Seven hundred and eighty-four participants with infertility without severe male factor will be included in the study and allocated randomly into two groups (IVF or ICSI). The main inclusion criteria for the women are age 18-42 years, normal to slightly decreased male partner sperm/ use of donor sperm and no prior fertility treatment. In addition to live birth rate, outcome measures include fertilisation rate, total fertilisation failure, embryo quality, clinical pregnancy, miscarriage rate, preterm delivery, birth weight and congenital anomalies of the child.

The study will be performed in accordance with the ethical principles in the Helsinki Declaration. The study is approved by the Scientific Ethical Committee of the Capital Region of Denmark and the Knowledge Centre on Data Protection Compliance. Study findings will be presented in international conferences and submitted for publication in peer-reviewed journals.


Condition or disease Intervention/treatment Phase
Infertility Procedure: IVF Procedure: ICSI Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 784 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: In Vitro Fertilisation Versus Intracytoplasmic Sperm Injection in Patients Without Severe Male Factor Infertility (INVICSI): a Randomised, Controlled, Multicentre Trial
Actual Study Start Date : November 15, 2019
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Active Comparator: Standard in vitro fertilisation (IVF)
Oocytes are fertilised with standard IVF. For details please see "Project Description".
Procedure: IVF
Fertilisation with standard in vitro fertilisation (IVF). For details please see "Project Description".

Active Comparator: Intracytoplasmic sperm injection (ICSI)
Oocytes are fertilised with ICSI. For details please see "Project Description".
Procedure: ICSI
Fertilisation with intracytoplasmic sperm injection (ICSI). For details please see "Project Description".




Primary Outcome Measures :
  1. Cumulative live birth rate [ Time Frame: Follow-up ends one year after inclusion af the last patient. ]

    The totality of live births following successive treatments in each of the two groups (IVF and ICSI).

    This includes transfer of fresh embryos and up to all cryopreserved-thawed embryos from the first stimulation cycle if pregnancy is not achieved by the initial fresh transfer or in case of freeze-all. Live birth rate is defined as the delivery of one or more living infants ≥22 weeks' gestation.



Secondary Outcome Measures :
  1. Fertilisation rate [ Time Frame: 16-20 hours after IVF/ICSI ]
    Fertilisation rate per aspirated oocyte retrieved. Defined as the appearance of 2 pronuclei (PN)

  2. Total fertilisation failure [ Time Frame: 16-20 hours after IVF/ICSI ]
    Cycles with total fertilisation failure

  3. Embryo quality [ Time Frame: Up to six days after oocyte pick-up ]
    Good quality blastocysts according to Gardner classification

  4. Time-lapse kinetics [ Time Frame: Follow-up ends one year after inclusion af the last patient ]
    Embryo time-lapse kinetics including cleavage patterns

  5. Embryo utilisation rate [ Time Frame: Up to six days after oocyte pick-up ]
    Number of transferred + cryopreserved embryos per number of 2 PN zygotes

  6. Cryopreservation [ Time Frame: Up to six days after oocyte pick-up ]
    Number of cryopreserved blastocysts

  7. Clinical pregnancy [ Time Frame: 11-21 days after embryo transfer ]
    Positive urine or serum hCG

  8. Multiple pregnancy [ Time Frame: Up to 12 weeks after embryo transfer ]
    Number of intrauterine gestations

  9. Ongoing pregnancy per transfer [ Time Frame: In gestational week 7-8 ]
    Fetal heart beat on ultrasound

  10. Cumulative pregnancy rates [ Time Frame: Follow-up ends one year after inclusion af the last patient ]
    The totality of clinical pregnancies following successive treatments. This includes transfer of fresh embryos and up to all cryopreserved-thawed embryos from the first stimulation cycle if pregnancy is not achieved by the initial fresh transfer.

  11. Biochemical pregnancy [ Time Frame: 11-21 days after embryo transfer ]
    Positive urine or serum hCG without any clinical signs of intra- or extrauterine pregnancy

  12. Miscarriage rate [ Time Frame: Follow-up ends one year after inclusion af the last patient ]
    Spontaneous or planned abortions

  13. PUL [ Time Frame: Follow-up ends one year after inclusion af the last patient ]
    Pregnancy of unknown location

  14. Ectopic pregnancy [ Time Frame: Follow-up ends one year after inclusion af the last patient ]
    Pregnancy outside the uterus

  15. Preterm delivery [ Time Frame: Follow-up ends one year after inclusion af the last patient ]
    Delivery before gestational week 37.

  16. Birth weight /weight for gestational age. [ Time Frame: Follow-up ends one year after inclusion af the last patient ]
    Weight of the baby

  17. Congenital anomaly [ Time Frame: Follow-up ends one year after inclusion af the last patient ]
    Diagnosed congenital anomalies. Diagnosed at birth.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women 18-42 years of age (both included) at the beginning of the ovarian stimulation
  • Regular natural menstrual cycle 21-35 days
  • BMI 18-35 kg/m2
  • Indication for IVF due to tubal factor infertility, unexplained infertility or light to moderate decreased semen quality
  • Women treated with gonadotrophin in a standard short or long protocol and receiving ovulation trigger for oocyte pick up
  • First treatment cycle for the couple
  • Male partner sperm with a minimum concentration of 5 mill. progressive motile after purification per ml (minimum 5 mill. progressive motile spermatozoa in the diagnostic semen sample) and minimum 4 % morphological normal spermatozoa. Alternatively use of donorsperm.
  • Willing to sign the informed consent

Exclusion Criteria:

  • Less than 5 mill. progressive motile spermatozoa per ml in the purified diagnostic semen sample or <4 % morphological normal spermatozoa
  • Ovarian cysts >4 cm
  • Known liver or kidney disease
  • Previous IVF or ICSI treatment
  • Use of donor oocytes or frozen oocytes
  • Unregulated thyroid disease
  • Endometriosis stage 3-4
  • Hypogonadotropic hypogonadism
  • Severe comorbidity (diabetes, cardiovascular, liver or kidney disease)
  • Not speaking / understanding Danish or English language
  • Previous inclusion in the study
  • Not willing to fulfil the inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04128904


Contacts
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Contact: Nina la Cour Freiesleben, PhD +45 38625414 nina.la.cour.freiesleben@regionh.dk

Locations
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Denmark
The Fertility Clinic, Rigshospitalet, Copenhagen University Hospital Not yet recruiting
Copenhagen, Denmark, 2100
Contact: Anja Pinborg, DMSc         
The Fertility Clinic, Herlev Hospital, Copenhagen University Hospital Not yet recruiting
Herlev, Denmark, 2730
Contact: Bugge Nøhr, PhD         
The Fertility Clinic, Nordsjællands Hospital, Hillerød Not yet recruiting
Hillerød, Denmark, 3400
Contact: Lars Franch Andersen, PhD         
The Fertility Clinic, Hvidovre Hospital, Copenhagen University Hospital Recruiting
Hvidovre, Denmark, 2650
Contact: Nina la Cour Freiesleben, PhD    +4538625414    nina.la.cour.freiesleben@regionh.dk   
Contact: Sine Berntsen, MD    +4538623281      
Sponsors and Collaborators
Copenhagen University Hospital, Hvidovre
Investigators
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Principal Investigator: Nina la Cour Freiesleben, ph.d. The Fertility Clinic, Hvidovre Hospital, Copenhagen University Hospital
Publications:

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Responsible Party: Nina la Cour Freiesleben, Chief Consultant, Ph.D., Clinical Associate Professor, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier: NCT04128904    
Other Study ID Numbers: INVICSI2019
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

All the individual participant data collected during the trial will be shared after deidentification upon request.

Study protocol, Statistical analysis plan, informed consent forms, clinical study report and analytic code will be available upon request.

Data will be available from 3 months following first publication and ending 5 years after the study has been concluded.

Individual participant data will be shared with researches who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available from 3 months following first publication and ending 5 years after the study has been concluded.
Access Criteria: Individual participant data will be shared with researches who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nina la Cour Freiesleben, Copenhagen University Hospital, Hvidovre:
Infertility
Non-male factor infertility
In vitro fertilisation (IVF)
Intracytoplasmic sperm injection (ICSI)
Assisted reproductive technologies (ART)
Live birth rate
Reproductive outcome
Additional relevant MeSH terms:
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Infertility