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Efficacy of Platelet-Derived Factor Concentrate Freeze-Dry (PFC-FD) Ovarian Injection Therapy for Cases of Ovarian Dysfunction (PFC-FD before and after study)

Evaluating the Effectiveness of PFC-FD Ovarian Injection Therapy (PFC-FD before and after study)

Kawamura Kazuhiro

Department of Obstetrics and Gynecology, Juntendo University Faculty of Medicine

3-1-3 Hongo, Bunkyo-ku Tokyo, Japan

kazuhironanami@gmail.com

Yoshida Tsukasa

Department of Obstetrics and Gynecology, Juntendo University Faculty of Medicine

3-1-3 Hongo, Bunkyo-ku Tokyo, Japan

+81-3-3813-3111

t.yoshida.wa@juntendo.ac.jp

Recruiting

July. 07, 2025

Interventional

single arm study

open(masking not used)

historical control

single assignment

treatment purpose

1. Women with infertility undergoing in vitro fertilization (IVF).
2. Patients aged 45 years or younger at the time of obtaining consent.
3. Patients with ovarian reserve function indicated by an AMH level under 0.50 ng/mL.
4. Patients receiving outpatient care at the participating medical institution.
5. Patients who have undergone two control ovarian stimulations within the past 6 months prior to enrollment.
6. Patients capable of providing informed consent and able to give written consent of their own free will.
7. Patients who, based on the inclusion and exclusion criteria, are deemed by the principal (or sub-investigator) to allow for an appropriate assessment of the efficacy and safety of this study.

1. Patients whose infertility is believed to be caused by severe spermatogenic dysfunction or diabetes in the partner or associated with the patients diabetes.
2. Patients who are judged to have impaired reproductive function due to gonadotoxic chemotherapy and/or radiotherapy received by themselves or their partner.
3. Patients unable to understand the content of this study due to mental illness or cognitive impairment.
4. Patients with prior participation in this study.
5. Other patients deemed unsuitable for participation in this study by the principal investigator or subinvestigator.

Female

Diminished Ovarian Reserve, Premature Ovarian Insufficiency

Ovarian Administration of PFC-FD

Primary Ovarian Insufficiency, Ovarian Reserve, Follicle Stimulating Hormone, Premature Menopause Infertility, Female

D008594

The rate of increase in the number of developing follicles before and after the intervention

1, Rate of increase in the number of developing follicles during the post observation period
(Defined as the proportion of cases showing an increase versus no increase in developing follicles when comparing pre and postobservation. The determination of increase or no increase is based on a comparison of the number of developing follicles at the first and second observations within each observation period.)

2, Change in the number of developing follicles
(The average values from two measurements within each observation period are compared.)

3, Number of oocytes retrieved
(The average values from two measurements within each observation period are compared.)

4, Fertilization rate
(Number of normally fertilized oocytes / Number of retrieved oocytes)
(The average values from two measurements within each observation period are compared.)

5, Rate of good-quality early embryos
(Number of embryos classified as Veeck Grade G1, G2, or G3 with over 4 cells / Total number of early embryos)
(The average values of the proportions from two measurements within each observation period are compared.)

6, Blastocyst formation rate at Day 5
(Number of blastocysts / Number of normally fertilized oocytes)
(The average values of the proportions from two measurements within each observation period are compared.)

7, Rate of good-quality blastocysts
(Number of blastocysts graded over Gardner 3BB / Total number of blastocysts)
(The average values of the proportions from two measurements within each observation period are compared.)

8, Change in ovarian reserve
(a. AMH levels, b. Antral Follicle Count (AFC))
(Change between the two measurements taken during the screening period and the fourth ovarian stimulation cycle)
(The average values of the changes from two measurements within each observation period are compared.)

+81-3-5802-1584

June. 25, 2025

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