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Results were not promising
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| Name | Class |
|---|---|
| Fertility Laboratories Of Colorado | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In Vitro Follicle Activation (IVA) | Experimental | Ovarian tissue will be removed and cultured in vitro with compounds to activate dormant follicles. Following activation, ovarian tissue will be auto-grafted and the patient monitored for follicular growth. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In Vitro Follicle Activation (IVA) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Offspring weight | The birth weight of children born | 1 year after egg retrieval |
| Offspring gender | The gender of children born | 1 year after egg retrieval |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca L Krisher, Ph.D. | NFFR | Principal Investigator |
| William B Schoolcraft, M.D. | Fertility Laboratories Of Colorado | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fertility Laboratories of Colorado | Lone Tree | Colorado | 80124 | United States | ||
| National Foundation for Fertility Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24082083 | Background | 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. | |
| 25567618 |
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| ID | Term |
|---|---|
| D016649 | Primary Ovarian Insufficiency |
| D007246 | Infertility |
| D006379 | Helping Behavior |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| Follicle Activation | Drug | 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. |
|
| 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 |
| Lone Tree |
| Colorado |
| 80124 |
| United States |
| 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. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D012919 | Social Behavior |
| D001519 | Behavior |