A Pilot Study to Determine the Feasibility, Acceptance, and Effectiveness of In-vitro Maturation … (NCT05793931) | Clinical Trial Compass
TerminatedNot Applicable
A Pilot Study to Determine the Feasibility, Acceptance, and Effectiveness of In-vitro Maturation in Patients Without IVF Coverage
Stopped: Funding expired 03/01/2023
United States40 participantsStarted 2021-11-16
Plain-language summary
The specific aim of this pilot study is to test the hypothesis that estrogen stimulated IVM will be non-inferior to traditional IVF, to determine the feasibility and acceptance of estrogen-stimulated in vitro maturation (IVM) among couples and if couples find value and satisfaction with IVM.
This project will determine the feasibility, acceptance, and cost-benefit of in vitro maturation (IVM) among 20 couples who have had unsuccessful attempts at pregnancy using oral medications or whose only option to achieve pregnancy is through in vitro fertilization (IVF) due to blocked fallopian tubes or low sperm counts.
Who can participate
Age range18 Years – 40 Years
SexALL
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Inclusion criteria
✓. Patients without insurance coverage for IVF
✓. Female partner between age 18-3540
✓. Female partner with a diagnosis of polycystic ovarian syndrome (PCOS) or polycystic appearing ovaries (PCAO) as defined by an antral follicle count ≥ 15
✓. Presence of both ovaries
✓. Female partner with body mass index (BMI) of 19-4035 kg/m2
✓. Female partner with a normal uterine cavity as assessed by hysteroscopy, hysterosalpingography, or sonohysterography within the last 12 months
✓. Female partner with a history of tubal sterilization OR Blocked fallopian tubes without evidence of a hydrosalpinx OR History of 3 or more previously failed cycles of ovulation induction with oral medications OR where IVF is recommended for the treatment of mild or moderate male factor infertility OR evidence of a polyp and infertility
✓. Male partner between age 18-45
Exclusion criteria
✕
What they're measuring
1
Statistical analysis of live birth rates from IVM
Timeframe: From treatment start to live birth (~10 months)