NCT02496598

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

2 years

First QC Date

July 7, 2015

Last Update Submit

August 27, 2018

Conditions

Primary Ovarian InsufficiencyInfertility

Keywords

Reproductive Techniques, AssistedOvarian Follicle

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (3)

  • Offspring weight

    1 year after egg retrieval

  • Offspring gender

    1 year after egg retrieval

  • Development of good quality blastocysts using the Gardner morphological blastocyst grading system

    1 week after egg retrieval

Study Arms (1)

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.

Procedure: In Vitro Follicle Activation (IVA)Drug: Follicle Activation

Interventions

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.

In Vitro Follicle Activation (IVA)
Follicle ActivationDRUG

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.

In Vitro Follicle Activation (IVA)

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Minors are excluded from participation in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fertility Laboratories of Colorado

Lone Tree, Colorado, 80124, United States

Location

National Foundation for Fertility Research

Lone Tree, Colorado, 80124, United States

Location

Related 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.

    PMID: 24082083BACKGROUND

  • 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.

    PMID: 25567618BACKGROUND

MeSH Terms

Conditions

Primary Ovarian InsufficiencyInfertilityHelping Behavior

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesSocial BehaviorBehavior

Study Officials

  • Rebecca L Krisher, Ph.D.

    NFFR

    PRINCIPAL INVESTIGATOR

  • William B Schoolcraft, M.D.

    Fertility Laboratories Of Colorado

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2015

First Posted

July 14, 2015

Study Start

July 1, 2015

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

August 29, 2018

Record last verified: 2018-08

Locations

US(2)