We propose a new controlled ovarian hyperstimulation (COH) protocol for polycystic ovary syndrome (PCOS).

UMIN ID: UMIN000045214

Registered date:21/08/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Polycystic ovary syndrome(PCOS)
• Date of first enrollment: 2021/08/06
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): From the third (or fifth) day of the period, 5mg (or 2.5mg) of Letrozole and 150iu of HMG were administered every day until the day of trigger administration. When the leading follicle reached 18mm in diameter, the injection of 0.25mg of GnRH antagonist started and continued until the day of the trigger shot. After confirmation that the largest follicle was 22-24 mm in diameter and E2 level was about 500-700pg/ml, 5000iu of HCG was administered as trigger and oocyte collection was performed 37 hours later under general anesthesia with Propofol. All embryos were cryopreserved after IVF or ICSI. 2.5mg of Letrozole, 0.5mg of Cabergoline and 0.25mg of GnRH antagonist were administered just after the oocyte retrieval for five days consecutively.

Outcome(s)

• Primary Outcome: To establish a new controlled ovarian stimulation (COS) protocol for polycystic ovary syndrome (PCOS) that does not cause ovarian hyper stimulation syndrome (OHSS) while maintaining egg quality.
• Secondary Outcome: 1)No adverse and after effect for ovarian function following using this COS 2)Comparison of proportions of fertilization, pregnancy and abortion with those of base line levels.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 40years-old
• Gender: Female
• Exclude criteria: 1)Patients with Severe Type2 diabetes. 2)Patients and Husband who can not obtain written informed consent. 3)Patients judged to be inappropriate for the study by the physicians.

Related Information

• Primary Sponsor: Saint Mother Clinic
• Source(s) of Monetary Support: Saint Mother Clinic