In Vitro Follicle Activation

Infertility Clinical Trial

— IVA  

Official title:

In Vitro Activation of Primordial Follicles as a Method to Treat Infertility Caused by Primary Ovarian Insufficiency

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02496598
• Other study ID #: NFFR-IVA-2015
• Status: Terminated
• Phase: N/A
• Start date: July 2015
• Est. completion date: July 2017

Study information

• Verified date: August 2018
• Source: National Foundation for Fertility Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of an experimental treatment, known as in vitro activation (IVA) of dormant ovarian follicles, for infertility in women diagnosed with primary ovarian insufficiency (POI).

Description:

The purpose of this study is to evaluate the effectiveness of an experimental treatment, known as in vitro activation (IVA) of dormant ovarian follicles, for infertility in women diagnosed with primary ovarian insufficiency (POI; also known as premature ovarian failure). Patients diagnosed with POI are infertile due to a lack of follicle growth and ovulation; oocyte donation is the only treatment option currently available to enable these women to have a child. IVA treatment may result in the rescue of the remaining primordial follicles within the ovary, thus making oocytes available for IVF, embryo production, transfer and pregnancy. In this experimental treatment, ovarian tissue is removed from the patient and cultured in vitro for 48 hours with specific compounds to activate dormant primordial follicles. Following activation ovarian tissue is auto-grafted to the serosa of the fallopian tube, and the patient is monitored for signs of follicle growth. Growing follicles are stimulated with exogenous hormones, followed by oocyte retrieval and IVF.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Women diagnosed with primary ovarian insufficiency (POI), seeking pregnancy and eligible for IVF at Colorado Center for Reproductive Medicine (Lone Tree, CO).

• Patients can be of any race, culture, sexual orientation or ethnicity.

Exclusion Criteria:

• Minors are excluded from participation in this study.

Related Conditions & MeSH terms

• Gonadal Dysgenesis
• Infertility
• Menopause, Premature
• Primary Ovarian Insufficiency
• Turner Syndrome

Intervention

Procedure:
• In Vitro Follicle Activation (IVA)
Laparoscopic removal of ovarian tissue, followed by in vitro activation of dormant ovarian follicles and autografting back to the patient for follicle growth and egg retrieval.

Drug:
• Follicle Activation
Ovarian cortical pieces will be treated in vitro with a PTEN activator (bpV(hopic)) and a PI3K inhibitor (740YP) in vitro to activate primordial ovarian follicles, prior to autografting.

Locations

Country	Name	City	State
United States	Fertility Laboratories of Colorado	Lone Tree	Colorado
United States	National Foundation for Fertility Research	Lone Tree	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
National Foundation for Fertility Research	Fertility Laboratories Of Colorado

Country where clinical trial is conducted

United States, 

References & Publications (2)

Kawamura K, Cheng Y, Suzuki N, Deguchi M, Sato Y, Takae S, Ho CH, Kawamura N, Tamura M, Hashimoto S, Sugishita Y, Morimoto Y, Hosoi Y, Yoshioka N, Ishizuka B, Hsueh AJ. Hippo signaling disruption and Akt stimulation of ovarian follicles for infertility treatment. Proc Natl Acad Sci U S A. 2013 Oct 22;110(43):17474-9. doi: 10.1073/pnas.1312830110. Epub 2013 Sep 30. — View Citation

Suzuki N, Yoshioka N, Takae S, Sugishita Y, Tamura M, Hashimoto S, Morimoto Y, Kawamura K. Successful fertility preservation following ovarian tissue vitrification in patients with primary ovarian insufficiency. Hum Reprod. 2015 Mar;30(3):608-15. doi: 10.1093/humrep/deu353. Epub 2015 Jan 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antral follicle development measured by ultrasound examination	Ultrasound analysis of the number of follicles developing in the grafted ovarian tissue following activation in vitro	1 year after auto-grafting
Primary	Recovery of oocytes by trans-vaginal ultrasound guided oocyte aspiration	The number of oocytes recovered from follicles developing in the grafted ovarian tissue following in vitro activation	1 year after auto-grafting
Primary	Pregnancy	The incidence of implantation and pregnancy following transfer of embryos produced from oocytes recovered from follicles developing in the activated ovarian tissue.	1.5 years after auto-grafting
Secondary	Offspring weight	The birth weight of children born	1 year after egg retrieval
Secondary	Offspring gender	The gender of children born	1 year after egg retrieval
Secondary	Development of good quality blastocysts using the Gardner morphological blastocyst grading system	The proportion of good quality blastocyst stage embryos developed during in vitro fertilization (IVF) cycle(s), of the total number of fertilized eggs	1 week after egg retrieval