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

NCT02322060 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-03-05

No results posted yet for this study

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.

Conditions

  • In Vitro Activation
  • Dormant Follicle
  • Primary Ovarian Insufficiency
  • Ovarian Resistance Syndrome

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

Sponsors & Collaborators

  • Stanford University

    collaborator OTHER
  • St. Marianna University School of Medicine

    collaborator OTHER
  • The First Affiliated Hospital of Zhengzhou University

    lead OTHER

Principal Investigators

  • Yingpu Sun, MD,PhD · The First Affiliated Hospital of Zhengzhou University

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2021-10-01
Completion
2021-10-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02322060 on ClinicalTrials.gov