J-FOCAL study

JRCT ID: jRCTs071180015

Registered date:30/01/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Infertility
• Date of first enrollment: 17/05/2018
• Target sample size: 180
• Study type: Interventional
• Intervention(s): Management of FET schedules

Outcome(s)

• Primary Outcome: Clinical pregnancy rate per FET
• Secondary Outcome: Biochemical pregnancy rate per FET,Early miscarriage rate,Bleeding rate,Ongoing pregnancy rate,Safety

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: <= 42age old
• Gender: Female

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Katagiri Yukiko
• Source(s) of Monetary Support: Merck Biopharma Co., Ltd
• Secondary ID(s): UMIN000031115