NCT02792569

Follicle Activation by Inhibition of the Hippo Pathway

Auto-transplantation of Fragmented Ovarian Cortical Tissue in Infertile Patients With Premature Ovarian Oocyte Depletion - a Study to Promote Follicular Activation and Subsequent Fertility

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Anders Nyboe Andersen · Academic / Other
• Sex: Female
• Age: 25 Years – 39 Years
• Healthy volunteers: Not accepted

Summary

The aim of this project is to activate recruitment and growth of resting primordial follicles in the ovaries of women with diminished ovarian reserve, in attempt to increase the chance to become pregnant, either naturally or after assisted reproduction.

Detailed description

For this study investigators will carefully select 20 women with low AMH and imminent POI. They will be randomized to have cortical ovarian biopsies taken from either the left or right ovary. The biopsies will be fragmented in 1x1 mm2 pieces and immediately auto-transplanted in a peritoneal pocket under the right ovary. The contralateral untouched ovary will act as the control, making each woman their own control. Follow up: each week in 2,5 months the women will be assessed by transvaginal ultrasound and hormonal status. After 2,5-6 months the women will receive a FSH stimulation cycle (rFSH 300 IU or Corifollitropin) followed by standard IVF/ICSI, Hypothesis: the ovaries contain a pool of resting primordial follicles. By fragmentation of cortical ovarian tissue, manipulation of the local environment in the tissue will inhibit the Hippo Pathway and hereby active recruitment and growth of primordial follicles.

Conditions

• Infertility

Interventions

Type	Name	Description
PROCEDURE	Biopsy of ovarian cortical tissue	Biopsies will be taken from either right or left side. The cortical tissue will be isolated and fragmented in 1x1 mm2 pieces, followed by auto-transplantation to a peritoneal pocket.

Timeline

• Start date: 2016-04-01
• Primary completion: 2018-12-01
• Completion: 2019-01-01
• First posted: 2016-06-07
• Last updated: 2020-01-30

Locations

1 site across 1 country: Denmark