NCT03914651

CLBR Per Initial Cycle With Different Starting Dose in Aged Patients With Poor Ovarian Reservation: 300IU Versus 150IU

Comparison of Cumulative Live Birth Rate Per Initial Cycle Between 300 IU and 150IU Starting Dose of rFSH Among Aged Patients With Poor Ovarian Reservation: a Randomized Controlled Trail

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya · Academic / Other
• Sex: Female
• Age: 35 Years – 42 Years
• Healthy volunteers: Not accepted

Summary

Among aged patients with poor ovarian reservation(defined as age 35 to 42 years; antral follicle count（AFC）≤ 5 or anti-mullerian hormone（AMH）≤ 1.2 ng/ml), cumulative live birth rate(CLBR) and time to live birth(TTLB) of the first stimulation cycle were compared between a starting dose of 300IU or 150IU rFSH in controlled ovarian stimulation with gonadotropin-releasing hormone（GnRH）antagonist protocol. This study is a prospective randomized controlled trial.

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	300IU rFSH Gonal-F® starting dose during controlled ovarian stimulation	On menstrual cycle day 2 or day 3, 300IU rFSH Gonal-F® will be administrated daily till the day of trigger. The dosage of rFSH can be adjusted only if there is a risk of ovarian hyperstimulation syndrome（OHSS）.
DRUG	150IU rFSH Gonal-F® starting dose during controlled ovarian stimulation	On menstrual cycle day 2 or day 3, 150IU rFSH Gonal-F® will be administrated daily till the day of trigger. The dosage of rFSH can be adjusted only if there is a risk of OHSS or insufficient follicular growth.

Timeline

• Start date: 2019-04-23
• Primary completion: 2022-12-30
• Completion: 2022-12-30
• First posted: 2019-04-16
• Last updated: 2022-01-12

Locations

1 site across 1 country: China