In Vitro Follicle Activation (IVA)

National Foundation for Fertility Research

Status: Terminated

Conditions: Infertility; Primary Ovarian Insufficiency

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02496598

NFFR-IVA-2015

Details and patient eligibility

About

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).

Full 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.

Enrollment: 2 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

In Vitro Follicle Activation (IVA)

Experimental group

Description:

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.

Treatment:

Drug: Follicle Activation

Procedure: In Vitro Follicle Activation (IVA)