Diminished Ovarian Reserve, Premature Ovarian Insufficiency Primary Ovarian Insufficiency, Ovarian Reserve, Follicle Stimulating Hormone, Premature Menopause Infertility, Female
Conditions
Interventions
Ovarian Administration of PFC-FD
Sponsors
Kawamura Kazuhiro
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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 oocyte retrievals 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.
Exclusion criteria
Exclusion criteria: 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 or their partners who have undergone treatment with reproductive toxic chemotherapeutic agents or radiation therapy. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of increase in the number of developing follicles before and after the intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.) | — |
Contacts
Public ContactTsukasa Yoshida
Department of Obstetrics and Gynecology, Juntendo University Faculty of Medicine
Outcome results
None listed