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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

Official Title
-----------------
Effect of Ovarian Stimulation Using Recombinant FSH and GHRH Antagonist in Alternate Days on ICSI Outcomes

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: Triptorelin
* Drug: Cetrorelix


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GnRH agonist<br>Administration of GnRH agonist in alternate days, recombinant FSH and hCG microdose for ovarian stimulation. | Drug: Triptorelin<br>* Triptorelin (0.1 mg, Gonapeptyl® Daily; Ferring, Kiel, Germany) in alternate-days from Day 1 of the menstrual cycle until the day of hCG administration.<br>* Other names: Gonapeptyl;|
| Active Comparator: GnRH antagonist<br>Daily administration of GnRH antagonist, recombinant FSH and hCG microdose for ovarian stimulation. | Drug: Cetrorelix<br>* When patients presented at least two follicles ≥ 14mm upon scan on days 7- 9, GnRH antagonist (cetrorelix, 0.25 mg/day, Cetrotide®; EMD Serono, Inc, Rockland, MA, USA) administration is started and continued until hCG administration.<br>* Other names: Cetrotide;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cost of treatment |  | One month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation and pregnancy rates |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ovarian stimulation, GnRH agonist, GnRH antagonist, hCG microdose, ICSI