Infertility
Conditions
Interventions
Management of FET schedules
Sponsors
Clinical Research Support Center Kyushu
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Japanese race 2)Patients wishing to undergo FET 3)Women with transplantable frozen blastocysts (blastocysts classified to grades other than C) who are indicated for FET in hormone replacement cycles 4)Healthy premenopausal woman under 42 years of age at the time of ET and wishing to conceive 5)Normal cervical cytology within 12 months prior to the date of informed consent [cervical cytology: Negative for Intraepithelial Lesion or Malignancy (NILM) or Atypical Squamous Cells of Undetermined Significance (ASC-US) and Human Papillomavirus (HPV) negative]. The test results can be reported by patients themselves (results must be recorded in the medical record). If results are not available, or if cytology was not performed during this period, cervical cytology and HPV test, if needed, will be performed during the screening period. 6)Written informed consent for participation obtained from the patient 7)First-time participation in this study
Exclusion criteria
Exclusion criteria: 1)Natural ovulation may be expected (mature follicles observed). 2)History of recurrent pregnancy loss (defined as 3 or more previous spontaneous abortions) 3)History of 3 or more consecutive cancelled or failed (no clinical pregnancy) ET cycles. 4)Underwent ovarian stimulation using clomiphene citrate in the previous cycle and not having menstruation following oocyte retrieval. 5)Abnormal hemorrhage of the reproductive tract of undetermined origin 6)Any contraindication to being pregnant and/or carrying a pregnancy to term 7)Endometriosis, uterine myoma, adenomyosis uteri, or uterine polyps requiring treatment 8)Extra-uterine pregnancy within the last 3 months prior to the date of informed consent 9)Ovarian enlargement or cyst of unknown etiology 10)Breast-feeding or lactation 11)Known Human Immunodeficiency Virus (HIV)-positive status, or a history of or current active infection with Hepatitis B or C. 12)History of allergy or hypersensitivity to progesterone preparations and/or their excipients, or any contraindication to receive progesterone preparations 13)History of or suspected alcohol or substance abuse within 5 years prior to the date of informed consent 14)Active thrombophlebitis, thromboembolic disorder or cerebral stroke, or a history of such conditions. 15)Judged as ineligible in the opinion of the site investigator or investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical pregnancy rate per FET | — |
Secondary
| Measure | Time frame |
|---|---|
| Biochemical pregnancy rate per FET,Early miscarriage rate,Bleeding rate,Ongoing pregnancy rate,Safety | — |
Countries
Japan
Contacts
Public ContactResearch Secretariat J-FOCAL study
Clinical Research Support Center Kyushu (CReS Kyushu) J-FOCAL study Research Secretariat
Outcome results
None listed