Overview

This trial is active, not recruiting.

Conditions primary ovarian insufficiency, infertility
Treatments in vitro follicle activation (iva), follicle activation
Sponsor National Foundation for Fertility Research
Collaborator Fertility Laboratories Of Colorado
Start date July 2015
End date July 2017
Trial size 2 participants
Trial identifier NCT02496598, NFFR-IVA-2015

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(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.
in vitro follicle activation (iva)
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.
follicle activation
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.

Primary Outcomes

Measure
Antral follicle development measured by ultrasound examination
time frame: 1 year after auto-grafting
Recovery of oocytes by trans-vaginal ultrasound guided oocyte aspiration
time frame: 1 year after auto-grafting
Pregnancy
time frame: 1.5 years after auto-grafting

Secondary Outcomes

Measure
Offspring weight
time frame: 1 year after egg retrieval
Offspring gender
time frame: 1 year after egg retrieval
Development of good quality blastocysts using the Gardner morphological blastocyst grading system
time frame: 1 week after egg retrieval

Eligibility Criteria

Female participants from 18 years up to 45 years old.

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.

Additional Information

Official title In Vitro Activation of Primordial Follicles as a Method to Treat Infertility Caused by Primary Ovarian Insufficiency
Principal investigator Rebecca L Krisher, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by National Foundation for Fertility Research.