Japanese study of the outcome of hormonally controlled FET cycles using OneCrinone as luteal support

Phase 4

• Conditions: Infertility

• Registration Number: JPRN-UMIN000031115
• Lead Sponsor: Clinical Research Support Center Kyushu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-02
• Study Completion: 2020-06-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate per FET

Secondary Outcome Measures

Name	Time	Method
Biochemical pregnancy rate per FET,Early miscarriage rate,Bleeding rate,Ongoing pregnancy rate,Safety