---
title: In Vitro Follicle Activation in Patient With Premature Ovarian Failure Under 36 Years Old
nct_id: NCT04131244
overall_status: COMPLETED
phase: NA
sponsor: Hacettepe University
study_type: INTERVENTIONAL
primary_condition: Activation of Primordial Follicles
countries: Turkey (Türkiye)
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04131244.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04131244"
ct_last_update_post_date: 2020-02-12
last_seen_at: "2026-05-12T07:22:35.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# In Vitro Follicle Activation in Patient With Premature Ovarian Failure Under 36 Years Old

**Official Title:** In Vitro Follicle Activation of Dormant Follicles in Patient With Premature Ovarian Failure Under 36 Years Old

**NCT ID:** [NCT04131244](https://clinicaltrials.gov/study/NCT04131244)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 10
- **Lead Sponsor:** Hacettepe University
- **Collaborators:** St. Marianna University School of Medicine, Stanford University
- **Conditions:** Activation of Primordial Follicles
- **Start Date:** 2017-12-01
- **Completion Date:** 2019-12-15
- **CT.gov Last Update:** 2020-02-12

## Brief Summary

This is a clinical trial that the investigators aim to validate In-vitro Activation (IVA) treatment protocol, which was previously defined by Kazuhiro Kawamura (MD) and Aaron Hsueh (PhD), in Turkish patient with Premature Ovarian Insufficiency (POI) under age 36.

## Detailed Description

The objectives of the study is as following;

* Validation of the previously defined In-Vitro Activation Protocol approach in Turkish patients under 36 years old with Premature Ovarian Insufficiency (POI).
* Giving an opportunity to young POI patient in Turkey for having genetically own baby.
* Primary outcome measure would be live birth.
* For activation of primordial follicles, phosphatase and tensin homolog (PTEN) inhibitor and protein kinase B (AKT) stimulator will be used.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 36 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Patient with POI
* Short amenorrhea period (1 - 2 years)

Exclusion Criteria:

* Having been treated with chemotherapy and/or radiotherapy;
* Having been diagnosed with advanced stage of endometriosis (endometriomas)
* Having been diagnosed with the chronic diseases such as diabetes, cardiac failure, kidney insufficiency, morbid obesity etc..
* Presence of chromosomal abnormality (Turner, Fragile-X etc.)
* Previous multiple laparotomies
* Menopause \>10 years
* Accompanied azoospermia
```

## Interventions

- **In vitro activation of primordial follicles by PTEN inhibitor and AKT stimulator** (PROCEDURE) — After laparoscopic unilateral oophorectomy, ovarian medulla would be dissected from cortex. After fragmentation of 2 cm square ovarian cortex into smaller pieces they would be incubated PTEN inhibitor and AKT stimulator for 48 hours. Finally we will auto graft these fragments beneath to the fallopian tube peritoneal surface.

## Primary Outcomes

- **Live birth** _(time frame: 2 years)_ — The primary outcome is live birth, defined as the delivery of a live-born infant at 24 weeks of gestation

## Secondary Outcomes

- **Follicle growth rate** _(time frame: 1 year)_
- **M-II oocyte rate** _(time frame: 1 year)_
- **Day 2-3 good quality embryo rate** _(time frame: 1 year)_
- **Clinical pregnancy rate** _(time frame: 2 years)_

## Locations (1)

- Hacettepe University School of Medicine, Department of Ob/Gyn, Ankara, Turkey (Türkiye)

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hacettepe university school of medicine, department of ob/gyn|ankara||turkey (türkiye)` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04131244.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04131244*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*