Status:
ACTIVE_NOT_RECRUITING
In Vitro Fertilisation Versus Intracytoplasmic Sperm Injection in Patients Without Severe Male Factor Infertility
Lead Sponsor:
Copenhagen University Hospital, Hvidovre
Conditions:
Infertility
Eligibility:
FEMALE
18-42 years
Phase:
NA
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 s...
Detailed Description
Background All over the world the use of intracytoplasmic sperm injection (ICSI) with the injection of a single spermatozoon into an oocyte has gradually increased since the first report of an ICSI c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 14 2027
Estimated Enrollment :
824 Patients enrolled
Trial Details
Trial ID
NCT04128904
Start Date
November 29 2019
End Date
December 14 2027
Last Update
February 11 2025
Active Locations (6)
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1
The Fertility Clinic, Rigshospitalet, Copenhagen University Hospital
Copenhagen, Denmark, 2100
2
The Fertility Clinic, Herlev Hospital, Copenhagen University Hospital
Herlev, Denmark, 2730
3
The Fertility Clinic, Nordsjællands Hospital, Hillerød
Hillerød, Denmark, 3400
4
The Fertility Clinic, the Reginal Hospital Horsens
Horsens, Denmark