Low Dose GnRHa Early Luteal Phase Down Regulation Versus GnRHa Ultra-short Protocol for Poor Ovarian Response

Navy General Hospital, Beijing

Status: Unknown

Conditions: Subfertility, Female; Ovulation Disorder

Treatments: Drug: human menopausal gonadotropin; Drug: Diphereline (Triptorelin embonate); Drug: Decapeptyl (Triptorelin); Drug: human chorionic gonadotropin

Study type: Interventional

Funder types: Other

Identifiers

NCT02940535

SW001

Details and patient eligibility

About

The management of the poor responder patients is very difficult. Currently, there is no any standard treatment for poor responder patients. The study is designed to test a modified GnRHa protocol for poor ovarian response, low dose GnRHa early luteal phase down regulation, compare with GnRHa ultra-short protocol. This is a randomized controlled trial.

Enrollment: 200 estimated patients

Sex: Female

Ages: 35 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least two of the following three features must be present: i. Advanced maternal age (≥40 years) or any other risk factor for POR (poor ovarian response); ii. A previous POR (≤3 oocytes with a conventional stimulation protocol); iii. An abnormal ovarian reserve test (i.e. AFC <7 follicles or AMH <1.1 ng/ml).

Exclusion criteria

• Contraindications for IVF/ICSI
• Contraindications for pregnancy
• Primary ovarian insufficiency
• AFC <3
• PGD/PGS

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Low Dose GnRHa

Experimental group

Description:

Diphereline 0.375mg was administered in the early-luteal-phase. Human menopausal gonadotropin/human chorionic gonadotropin (HMG/HCG) was administered start in the day 28.

Treatment:

Drug: Diphereline (Triptorelin embonate)

Drug: human menopausal gonadotropin

Drug: human chorionic gonadotropin

GnRHa Ultra-short Protocol

Active Comparator group

Description:

Decapeptyl 0.1mg was administered in the menstrual day 2 to 7. Human menopausal gonadotropin/human chorionic gonadotropin (HMG/HCG) was administered start in the menstrual day 2.

Treatment:

Drug: human menopausal gonadotropin

Drug: human chorionic gonadotropin

Drug: Decapeptyl (Triptorelin)