In Vitro Maturation for Infertility

Overseen By Ye Yuan, PhD

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Colorado Center for Reproductive Medicine

Disqualifiers: More than 2 failed IVF cycles

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

50 Participants Needed

Trial Summary

What is the purpose of this trial?

CCRM Fertility, a global pioneer in fertility treatment, research and science, is seeking participants for a new study on in vitro maturation (IVM). IVM requires less hormones to stimulate the ovaries than IVF, making it more affordable than IVF with fewer side effects. Participants that qualify for the study will receive a free cycle of IVM treatment at CCRM Fertility and including a new patient consultation, fertility testing, preimplantation genetic testing for aneuploidies (PGT-A), anesthesia and some medication

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment In Vitro Maturation (IVM) for infertility?

Research shows that In Vitro Maturation (IVM) has led to approximately 5000 live births since the 1970s and is particularly beneficial for patients with polycystic ovary syndrome (PCOS) or those at risk of ovarian hyperstimulation syndrome. IVM can also prevent the cancellation of IVF cycles in patients who do not respond well to traditional hormone treatments. ^{1 2 3 4 5}

Is in vitro maturation (IVM) safe for humans?

In vitro maturation (IVM) is generally considered a safe procedure, especially for patients with polycystic ovary syndrome (PCOS). It reduces the risk of ovarian hyperstimulation syndrome (OHSS), and about 5000 live births have occurred with IVM, with children reported to be healthy. ^{2 4 6 7 8}

How is the treatment In Vitro Maturation (IVM) different from other infertility treatments?

In Vitro Maturation (IVM) is unique because it allows immature eggs to mature in the lab without the need for extensive hormone stimulation, which is often required in standard IVF treatments. This makes IVM a safer option for patients at risk of ovarian hyperstimulation syndrome and those with conditions like polycystic ovary syndrome (PCOS). ^{2 3 9 10 11}

Eligibility Criteria

This trial is for women facing infertility issues, particularly those with Polycystic Ovary Syndrome (PCOS), tubal factors, or a low ovarian reserve. Healthy individuals can also apply. To qualify, participants must be seeking fertility treatment and willing to undergo in vitro maturation (IVM).

Inclusion Criteria

I agree to embryo biopsy for genetic testing.

Intend to perform embryo transfer within 4 months after completing the IVM cycle

Antral follicle count (AFC) greater than 24

Exclusion Criteria

More than 2 failed IVF cycles

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a three-day low dose stimulation followed by egg retrieval and in vitro maturation of oocytes

1 week

Multiple visits for stimulation, retrieval, and laboratory procedures

Embryo Development and Transfer

Mature oocytes are fertilized and cultured to the blastocyst stage, followed by biopsy and frozen embryo transfer

2 weeks

Visits for embryo transfer and monitoring

Follow-up

Participants are monitored for pregnancy outcomes and live birth data collection

12 months

Regular follow-up visits and patient contact

Treatment Details

Interventions

• IVM

Trial Overview The study tests IVM, an alternative to IVF that uses fewer hormones to mature eggs outside the body. Qualified participants will receive a free IVM cycle at CCRM Fertility including consultation, testing, genetic screening of embryos (PGT-A), anesthesia, and some medications.

Participant Groups

Group I: Biphasic IVM Treatment Experimental Treatment 1 Intervention

Biphasic IVM of oocytes

IVM is already approved in United States, European Union, Canada for the following indications:

Approved in United States as IVM for:

• Infertility due to polycystic ovary syndrome (PCOS)
• Infertility due to ovarian hyperstimulation syndrome (OHSS) risk
• Fertility preservation before gonadotoxic cancer treatment

Approved in European Union as IVM for:

• Infertility due to PCOS
• Infertility due to OHSS risk
• Fertility preservation before gonadotoxic cancer treatment

Approved in Canada as IVM for:

• Infertility due to PCOS
• Infertility due to OHSS risk
• Fertility preservation before gonadotoxic cancer treatment

Who Is Running the Clinical Trial?

Colorado Center for Reproductive Medicine

Lead Sponsor

Trials

7

Recruited

700+

Findings from Research

In-vitro maturation (IVM) of immature oocytes, especially when combined with hormonal priming, has shown improved maturation rates and embryo quality, leading to pregnancy rates of 30-35% in women with polycystic ovaries or polycystic ovary syndrome.

Over 300 healthy infants have been born from IVM, demonstrating its efficacy as a viable alternative to traditional IVF methods, allowing for successful pregnancies without the need for ovarian stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

State of the art in in-vitro oocyte maturation. Chian, RC., Lim, JH., Tan, SL.[2019]

In vitro maturation (IVM) is a safer alternative to conventional IVF, particularly for patients at risk of ovarian hyperstimulation syndrome, with approximately 5000 live births reported since its inception.

While IVM shows lower live birth and implantation rates compared to conventional IVF, it significantly reduces the risk of ovarian hyperstimulation syndrome, making it a valuable option for carefully selected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro maturation and its role in clinical assisted reproductive technology. Sauerbrun-Cutler, MT., Vega, M., Keltz, M., et al.[2022]

In vitro maturation (IVM) is an effective technique for maturing immature oocytes, particularly beneficial for patients with polycystic ovary syndrome (PCOS) and those who do not respond well to traditional IVF treatments.

A case study demonstrated that IVM successfully salvaged an IVF cycle for a patient with poor response to gonadotrophin stimulation, suggesting its potential as a viable alternative for various patient profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro maturation may prevent the cancellation of in vitro fertilization cycles in poor responder patients: A case report. Yalçınkaya, E., Calışkan, E., Budak, O.[2021]

In vitro maturation (IVM) is a modified IVF technique that allows for the collection of immature oocytes, reducing the need for gonadotrophin stimulation and minimizing the risk of ovarian hyperstimulation syndrome (OHSS), especially in high-risk patients like those with polycystic ovary syndrome (PCOS).

Recent advancements in IVM, including pre-maturation protocols and new culture media additives, have improved success rates and demonstrated safety regarding neonatal and childhood outcomes, making it a promising option for fertility preservation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro maturation. Walls, ML., Hart, RJ.[2019]

Rescue in vitro maturation (IVM) can be an effective alternative for polycystic ovarian syndrome (PCOS) patients undergoing IVF who are at risk of ovarian hyperstimulation syndrome (OHSS) or have poor responses to ovarian stimulation, as demonstrated in a study of five patients.

In the study, IVM led to successful oocyte retrieval and resulted in live births for some patients, indicating that this approach can mitigate risks associated with traditional IVF methods while still achieving positive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rescue In Vitro Maturation in Polycystic Ovarian Syndrome Patients Undergoing In Vitro Fertilization Treatment who Overrespond or Underrespond to Ovarian Stimulation: Is It A Viable Option? A Case Series Study. Fatum, M., Bergeron, ME., Ross, C., et al.[2022]

In-vitro maturation (IVM) allows immature oocytes to mature from the germinal vesicle stage to metaphase 2 in about 28-36 hours, showing promise for patients with polycystic ovarian syndrome and normal menstruating women.

Approximately 300 healthy children have been born worldwide from IVM, indicating its potential as a safe alternative to standard ovarian stimulation, although further research is needed to fully understand its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons learned from introducing an in-vitro maturation programme into clinical practice. von Otte, S., Schöpper, B., Diedrich, K., et al.[2019]

In a study of 531 women with polycystic ovary syndrome (PCOS), switching from in vitro fertilization (IVF) to in vitro maturation (IVM) did not significantly change cumulative live birth rates, but natural IVM showed a higher clinical pregnancy rate (36.0% vs. 26.0%).

Both natural IVM and switching to IVF/M had no cases of ovarian hyperstimulation syndrome (OHSS), indicating that these procedures are safe and effective options for managing infertility in PCOS patients with unexpected poor ovarian response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness, Flexibility and Safety of Switching IVF to IVM as a Rescue Strategy in Unexpected Poor Ovarian Response for PCOS Infertility Patients. Guo, W., Zheng, X., Zheng, D., et al.[2023]

Oocyte in vitro maturation (IVM) is a well-established assisted reproductive technology that allows for the collection and maturation of immature oocytes, but its clinical use remains limited despite its non-experimental status.

This review aims to educate reproductive medicine professionals on the safe and effective application of IVM, highlighting its potential benefits for specific patient groups based on the latest evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives on the development and future of oocyte IVM in clinical practice. De Vos, M., Grynberg, M., Ho, TM., et al.[2021]

The study found that a specific combination of 15 μg/ml selenium, 10 μg/ml calcium, and 5 μg/ml calcium ionophore resulted in the highest rates of human oocyte maturation (68% MII), development beyond the morula stage (20.1%), and blastocyst formation (11.1%).

The research suggests that adjusting intracellular ion concentrations can effectively trigger oocyte maturation and activation, indicating that these combinations could enhance in vitro maturation (IVM) protocols in assisted reproductive technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of selenium, calcium and calcium ionophore on human oocytes in vitro maturation in a chemically defined medium. Makki, M., Saboori, E., Sabbaghi, MA., et al.[2021]

In vitro maturation (IVM) is a technique that allows immature oocytes to mature without the need for hormonal stimulation, making it a safer option for patients at high risk of ovarian hyperstimulation.

The results from IVM are comparable to standard IVF techniques, and there is currently no evidence of increased risk for fetal malformations, making it a suitable alternative for specific patients, particularly those with PCOS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro maturation (IVM) of human oocytes. Strowitzki, T.[2013]

In vitro maturation (IVM) is gaining recognition as a viable alternative to conventional in vitro fertilization (IVF), particularly in areas like fertility preservation and managing Ovarian Hyperstimulation Syndrome.

This systematic review highlights the extensive research supporting IVM's application across various fertility treatments, indicating its potential to be integrated more widely into assisted reproductive technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oocyte in vitro maturation: A sytematic review. Hatırnaz, Ş., Ata, B., Hatırnaz, ES., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

State of the art in in-vitro oocyte maturation. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

In vitro maturation and its role in clinical assisted reproductive technology. [2022]

3. Turkey pubmed.ncbi.nlm.nih.gov

In vitro maturation may prevent the cancellation of in vitro fertilization cycles in poor responder patients: A case report. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

In vitro maturation. [2019]

5. Iran pubmed.ncbi.nlm.nih.gov

Rescue In Vitro Maturation in Polycystic Ovarian Syndrome Patients Undergoing In Vitro Fertilization Treatment who Overrespond or Underrespond to Ovarian Stimulation: Is It A Viable Option? A Case Series Study. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Lessons learned from introducing an in-vitro maturation programme into clinical practice. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness, Flexibility and Safety of Switching IVF to IVM as a Rescue Strategy in Unexpected Poor Ovarian Response for PCOS Infertility Patients. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Perspectives on the development and future of oocyte IVM in clinical practice. [2021]

9. Iran pubmed.ncbi.nlm.nih.gov

Effects of selenium, calcium and calcium ionophore on human oocytes in vitro maturation in a chemically defined medium. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

In vitro maturation (IVM) of human oocytes. [2013]

11. Turkey pubmed.ncbi.nlm.nih.gov

Oocyte in vitro maturation: A sytematic review. [2020]