Ovarian Stimulation Using Recombinant Follicle-stimulating Hormone (FSH) and Gonadotrophin Releasing Hormone (GnRH) Agonist in Alternate Days (Gonapeptyl)

Fertility - Assisted Fertilization Center

Status: Completed

Conditions: Infertility

Treatments: Drug: Cetrorelix; Drug: Triptorelin

Study type: Interventional

Funder types: Other

Identifiers

NCT01468441

Fert-LG-Doutorado

Details and patient eligibility

About

The present prospective study was designed to compare the effects of administering a daily dose of gonadotrophin releasing hormone (GnRH) antagonist vs. an alternate-day dosage of GnRH agonist on ovarian response and in vitro fertilization (IVF) outcome in patients stimulated with recombinant follicle-stimulating hormone (FSH) and human chorionic gonadotrophin (hCG) microdose.

Full description

Inclusion criteria were as follows: women of good physical and mental health, under 37 years old, with regular menstrual cycles of 25-35 days, normal basal FSH and luteinizing hormone (LH) levels, body mass index (BMI) less than 30 kg/m2, presence of both ovaries and intact uterus, absence of polycystic ovaries, endometriosis, or gynaecological / medical disorders and a negative result in a screening for sexually transmitted diseases.

No patient had received any hormone therapy for at least 60 days preceding the study. Eligible patients who agreed to participate were randomized in two treatment groups. Patients were allocated to a GnRH analogue treatment group according to a computer-generated randomization table.

Enrollment: 96 patients

Sex: Female

Ages: Under 35 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• women of good physical and mental health
• under 37 years old, with regular menstrual cycles of 25-35 days
• normal basal FSH and LH levels
• BMI less than 30 kg/m2
• presence of both ovaries and intact uterus
• absence of polycystic ovaries
• endometriosis, or gynaecological / medical disorders and a negative result in a screening for sexually transmitted diseases
• all patients signed a written informed consent form
• no patient had received any hormone therapy for at least 60 days preceding the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 2 patient groups

GnRH agonist

Experimental group

Description:

Administration of GnRH agonist in alternate days, recombinant FSH and hCG microdose for ovarian stimulation.

Treatment:

Drug: Triptorelin

GnRH antagonist

Active Comparator group

Description:

Daily administration of GnRH antagonist, recombinant FSH and hCG microdose for ovarian stimulation.

Treatment:

Drug: Cetrorelix