Clinical trial NCT02496598: In Vitro Follicle Activation
Official title: In Vitro Activation of Primordial Follicles as a Method to Treat Infertility Caused by Primary Ovarian Insufficiency
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Primary Ovarian Insufficiency
Infertility
Keywords: Reproductive Techniques, Assisted
Ovarian Follicle
Lead sponsor: National Foundation for Fertility Research
Sponsor class: OTHER
Collaborators: name: Fertility Laboratories Of Colorado
First posted: 2015-07-14
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Antral follicle development measured by ultrasound examination
timeFrame: 1 year after auto-grafting
measure: Recovery of oocytes by trans-vaginal ultrasound guided oocyte aspiration
timeFrame: 1 year after auto-grafting
measure: Pregnancy
timeFrame: 1.5 years after auto-grafting
Secondary outcomes:
measure: Offspring weight
timeFrame: 1 year after egg retrieval
measure: Offspring gender
timeFrame: 1 year after egg retrieval
measure: Development of good quality blastocysts using the Gardner morphological blastocyst grading system
timeFrame: 1 week after egg retrieval
Other outcomes:
Locations:
city: Lone Tree
country: United States
facility: Fertility Laboratories of Colorado
state: Colorado
city: Lone Tree
country: United States
facility: National Foundation for Fertility Research
state: Colorado
Study officials:
affiliation: NFFR
name: Rebecca L Krisher, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Fertility Laboratories Of Colorado
name: William B Schoolcraft, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.