Low Dose hCG in the Late Follicular Phase

Universitair Ziekenhuis Brussel

Status and phase: Completed; Phase 4

Conditions: Infertility

Treatments: Drug: recombinant gonadotropins; Drug: human chorionic gonadotropin

Study type: Interventional

Funder types: Other

Identifiers

NCT00750100

EC REF 2006-157

Details and patient eligibility

About

In this study,the investigators compared two protocols for controlled ovarian hyperstimulation in infertility patients requiring IVF. In the control group, the patient undergoes a standard antagonist protocol. In the study group, the administration of gonadotropins is stopped in the late follicular phase and replaced by low dose human chorionic gonadotropins. The primary endpoint of the study is the number of oocytes retrieved in both groups.

Enrollment: 70 patients

Sex: Female

Ages: 18 to 36 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• < 36 years on day of randomisation
• FSH < 12 in the early follicular phase
• Normal ultrasound scan
• BMI between 18 and 29 (both inclusive)
• Randomisation at outpatient clinic

Exclusion criteria

• Endometriosis ≥ grade 3
• PCO syndrome
• Poor responder
• Endocrine or metabolic abnormalities

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

A

Active Comparator group

Description:

Patients undergo a standard antagonist protocol for in-vitro fertilisation, and are stimulated with recombinant gonadotropins.

Treatment:

Drug: recombinant gonadotropins

B

Experimental group

Description:

Patients are undergo an antagonist protocol for in-vitro fertilisation and are stimulated with recombinant gonadotropins. When the patient has an estradiol value of 600 ng/L or more and when the patient has at least 6 follicles of 12 mm, the administration of gonadotropins is stopped and replaced by low dose human chorionic gonadotropins.

Treatment:

Drug: human chorionic gonadotropin