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Clinical Trials/NCT02496598
NCT02496598TerminatedNot Applicable

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

National Foundation for Fertility Research2 sites in 1 country2 target enrollmentStarted: July 2015Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
2
Locations
2
Primary Endpoint
Recovery of oocytes by trans-vaginal ultrasound guided oocyte aspiration

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Arms & Interventions

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.

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

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.

Intervention: Follicle Activation (Drug)

Outcomes

Primary Outcomes

Recovery of oocytes by trans-vaginal ultrasound guided oocyte aspiration

Time Frame: 1 year after auto-grafting

The number of oocytes recovered from follicles developing in the grafted ovarian tissue following in vitro activation

Pregnancy

Time Frame: 1.5 years after auto-grafting

The incidence of implantation and pregnancy following transfer of embryos produced from oocytes recovered from follicles developing in the activated ovarian tissue.

Antral follicle development measured by ultrasound examination

Time Frame: 1 year after auto-grafting

Ultrasound analysis of the number of follicles developing in the grafted ovarian tissue following activation in vitro

Secondary Outcomes

  • Offspring gender(1 year after egg retrieval)
  • Development of good quality blastocysts using the Gardner morphological blastocyst grading system(1 week after egg retrieval)
  • Offspring weight(1 year after egg retrieval)

Investigators

Sponsor
National Foundation for Fertility Research
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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