Health TrialsbyHealthPanel

Safety Evaluation of the HyperSperm Sperm Preparation Procedure for In Vitro Fertilization

ConditionInfertility
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-45
SponsorFecundis Lab SL

About this trial

Prospective, multicenter, randomized clinical study evaluating the safety of a novel sperm preparation method for in vitro fertilization (IVF), compared to standard sperm preparation procedures.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Couples undergoing in vitro fertilization (IVF) treatment.

Planned use of fresh sperm samples obtained by masturbation.

Age between 20 and 42 years.

Antral follicle count ≥ 4.

Disqualifiers

Active sexually transmitted infection (STI).

Use of donor sperm.

Medical conditions contraindicating pregnancy or the IVF procedure.

Uterine anomalies associated with distortion of the uterine cavity.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard Sperm Preparation

    Device

    Standard sperm preparation

  • HyperSperm

    Device

    Multi-step sperm preparation

Treatment groups

202 Participants
are divided into 2 treatment groups
Group A: Standard Sperm PreparationActive comparator 1 intervention
Group B: HyperSpermExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Euploidy Rate

Proportion of embryos identified as euploid following preimplantation genetic testing (PGT) performed on embryos generated during the IVF cycle.

Time frame
From embryo biopsy and PGT analysis up to completion of genetic results, within the IVF cycle (approximately 5-7 days post-fertilization).

Secondary outcomes

1

Clinical Pregnancy Rate

Proportion of subjects with a clinical pregnancy, defined as the presence of an intrauterine gestational sac detected by ultrasound.

Time frame
5-7 weeks of gestation following embryo transfer.
2

Fertilization Rate

Proportion of oocytes successfully fertilized following insemination during IVF.

Time frame
Approximately 16-20 hours after insemination.
3

Cleavage Rate

Proportion of fertilized embryos progressing to the cleavage stage.

Time frame
Day 2-3 after fertilization.
4

Blastocyst Formation Rate

Proportion of embryos that develop to the blastocyst stage.

Time frame
Day 5-6 after fertilization.

Other outcomes

1

Ongoing Pregnancy Rate

Proportion of pregnancies progressing beyond the first trimester without pregnancy loss.

Time frame
Up to 12-14 weeks of gestation.
2

Live Birth Rate

Proportion of pregnancies resulting in the birth of a live neonate.

Time frame
At delivery. Approximately 38-42 weeks after embryo transfer.
3

Neonatal Sex Distribution

Sex of neonates born from pregnancies resulting from the study.

Time frame
At birth. Approximately 38-42 weeks after embryo transfer.
4

Birth Weight

Birth weight of neonates resulting from pregnancies in the study.

Time frame
At birth. Approximately 38-42 weeks after embryo transfer.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fecundis Lab SL

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: