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

NCT04128904 · tracked via the Priya Life Science Denmark tracker

Sponsor

Copenhagen University Hospital, Hvidovre

Phase

Not applicable

Started

2019-11-29

Last updated

2025-02-11

Condition(s) studied

Infertility

Investigational drug(s) / intervention(s)

IVFICSI

IVF: Fertilisation with standard in vitro fertilisation (IVF). For details please see "Project Description".

ICSI: Fertilisation with intracytoplasmic sperm injection (ICSI). For details please see "Project Description".

Study 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.

A total of 824 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.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

42 Years

Healthy volunteers

Inclusion Criteria: * Women 18-42 years of age (both included) at the beginning of the ovarian stimulation * BMI 18-35 kg/m2 * Indication for IVF due to tubal factor infertility, unexplained infertility, PCOS 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 with normal or non-severely decreased sperm parameters, where the sperm sample (purified) on the day of oocyte pick up is expected to contain a minimum of 2 million/mL progressive motile spermatozoa. Alternatively use of donorsperm. * Willing to sign the informed consent Exclusion Criteria: * Ovarian cysts \>4 cm * Known liver or kidney disease * Previous IVF or ICSI treatment with current partner * Use of donor oocytes or frozen oocytes * Unregulated thyroid disease * Endometriosis stage 3-4 * Hypogonadotropic hypogonadism * Severe comorbidity (e.g. diabetes or cardiovascular disease) * Not speaking / understanding Danish or English language * Not willing to sign the informed consent

Primary outcome measure(s)

Cumulative live birth rate from first live birth episode of a study cycle — Minimum follow-up time is one year after inclusion
The cumulative first live birth from the oocyte collection. Includes transfer of fresh embryos and frozen-thawed embryos.

Trial sites (6)

Facility	City	Region
The Fertility Clinic, Rigshospitalet, Copenhagen University Hospital	Copenhagen	Denmark
The Fertility Clinic, Herlev Hospital, Copenhagen University Hospital	Herlev	Denmark
The Fertility Clinic, Nordsjællands Hospital, Hillerød	Hillerød	Denmark
The Fertility Clinic, the Reginal Hospital Horsens	Horsens	Denmark
The Fertility Clinic, Hvidovre Hospital, Copenhagen University Hospital	Hvidovre	Denmark
The Fertility Clinic, Zealand University Hospital	Køge	Denmark

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04128904 on ClinicalTrials.gov ↗ ← All trials in Denmark