A Pilot Study to Determine the Feasibility, Acceptance, and Effectiveness of In-vitro Maturation in Patients Without IVF Coverage

NCT05793931 | Terminated

• 1 other identifier: STU00213583
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

IVM; PCOS

Keywords

IVM; PCOS; PCAO

Outcome Measures

Primary Outcomes (1)

• Statistical analysis of live birth rates from IVM

  Measurements for analysis include: gestational age at delivery, mode of delivery, birth weight, gender, neonatal and obstetric complications

  From treatment start to live birth (~10 months)

Secondary Outcomes (4)

• Statistical analysis of IVM on oocyte retrieval and maturation

  From treatment start to day 3 or day 5 of blastocyst development (~3 weeks)

• Statistical analysis of IVM on embryo parameters

  From fertilization to day 3 or day 5 of blastocyst development (up to 1 week)

• Efficacy of IVM on pregnancy

  From treatment start to birth or loss (up to 10 months)

• Statistical analysis of IVM on endometrial response to hormones

  From treatment start to hCG trigger (~2 weeks)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

We seek to recruit 20 couples that fit the inclusion criteria as stated above.

You may qualify if:

• 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
• Male partner must be able to produce fresh semen sample
• Male partner with sperm concentration ≥ 5 million sperm/mL and sperm motility ≥ 25%
• English speaking

You may not qualify if:

• Frozen sperm source
• Presence of ovarian pathology (i.e., endometrioma, fibroma)
• History of HIV or acute hepatitis infection
• History of chemotherapy or pelvic radiation therapy
• Any active, uncontrolled, clinically significant medical condition as determined by the investigator
• Contradiction to pregnancy
• Adults unable to consent
• Pregnant women
• Prisoners

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 31, 2023
• Study Start: November 16, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

US (1)