Fertilo In Vitro Research Study and Trial
ConditionIn Vitro Maturation of Oocytes
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorGameto, Inc.
About this trial
The goal of this clinical trial is to evaluate the safety and efficacy of using Fertilo for In vitro maturation (IVM) in participants 18-35 years of age. The main question it aims to answer is whether the use of Fertilo is superior to using Medicult IVM for In vitro maturation.
Researchers will compare the number of ongoing pregnancies at 12 weeks gestation for participants in each arm.
* Arm 1 participants will have all cumulus oocyte complexes (COCs), or eggs surrounded by helper cells, cultured in Fertilo for 30 hours. * Arm 2 participants will have all cumulus oocyte complexes (COCs), or eggs surrounded by helper cells, cultured in Medicult IVM for 30 hours.
Eligibility criteria
Qualifiers
Written informed consent.
Premenopausal, Age 18-35.
Body mass index (BMI) 21-40.
Candidate for IVF according to the ASRM definition (infertile for ≥12 months, require the use of donor sperm, or the inability to achieve a successful pregnancy based on a patient's medical, sexual, and reproductive history, age, physical findings, diagnostic testing, or any combination of those factors).
Disqualifiers
History of recurrent pregnancy loss (defined as >2 clinical pregnancies without live birth).
Baseline prolactin levels greater than 30 ng/ml
Male: requirement for retrograde ejaculation procedures or surgical sperm retrievals.
Any clinically relevant pathology that in the judgment of the investigator could impair embryo implantation or pregnancy continuation.
Trial design
Treatments tested in this trial
- Fertilo
- Medicult IVM
Treatment groups
500 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov