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COMPLETED
NCT02322060

In Vitro Activation of Dormant Follicles for Patients With Primary Ovarian Insufficiency

Sponsor: The First Affiliated Hospital of Zhengzhou University

View on ClinicalTrials.gov

Summary

In this study, the investigators used the newly developed technique i.e. in vitro activation of dormant follicles (IVA) to promote ovarian follicle growth much more efficiently than natural, in vivo process for women with Primary Ovarian Insufficiency (POI).Firstly, the investigators remove one ovary under laparoscopic surgery. Then, we dissect ovarian cortex from the ovarian medulla. The ovarian cortex is cut into small cubes and cultured with medium containing drugs to activate dormant follicles. After 2 days of culture, the ovarian cubes are transplanted mainly beneath the membrane of Fallopian tubes under laparoscopic surgery. The ovarian cortex could be cryopreserve for future re-transplantation and in some cases, for convenience to arrange second surgery. Once frozen, the ovary can be preserved semipermanently. After transplantation, patients receive ultrasound monitoring together with measurement of serum hormone levels for 10-12 months. If growing follicles are detected, follicle growth is stimulated by injection of hormones (gonadotropins). Using the same "ovum pick up" approach used in IVF (in vitro fertilization), we pick up oocytes from the follicles and fertilize them. Fertilized eggs are cultured and then cryopreserved for future embryo transfer. Currently, we recurit patients diagnosed with POI, or Ovarian resistance syndrome (ORS). The procedure can also be: Only superficial cut of the ovarian cortex by laparoscopy or laparotomy, without taking ovary outside or cultured with medium.

Official title: Ovarian Tissue Cryopreservation and Auto-transplantation for in Vitro Activation of Dormant Follicles for Patients With Primary Ovarian Insufficiency

Key Details

Gender

FEMALE

Age Range

18 Years - 39 Years

Study Type

OBSERVATIONAL

Enrollment

35

Start Date

2014-09

Completion Date

2021-10

Last Updated

2026-05-27

Healthy Volunteers

No

Interventions

PROCEDURE

Ovariotomy

Remove one ovary (maybe both ovaries depending on the condition) by laparoscopic surgery or by laparotomy in some cases.

PROCEDURE

Activate dormant follicles

Cut ovary into small cubes, which are then cultured with medium containing BPV(pic), a PTEN inhibitor, and 740YP, an activator of phosphoinositol 3 kinase, to activate dormant follicles for 2 days before transplantation.

PROCEDURE

Ovary tissue transplantation

After extensive washing to remove drugs, the ovary cubes are transplanted beneath the membrane of both Fallopian tubes and the remaining ovary under laparoscopic surgery.

PROCEDURE

Ovarian superficial cut

Superficial cut of the ovarian cortex by laparoscopy or laparotomy

Locations (1)

Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China