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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01468441
Acronym
Gonapeptyl
Enrollment
96
Registered
2011-11-09
Start date
2011-09-30
Completion date
2012-03-31
Last updated
2012-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

ovarian stimulation, GnRH agonist, GnRH antagonist, hCG microdose, ICSI

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.

Interventions

DRUGTriptorelin

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.

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.

Sponsors

Fertility - Assisted Fertilization Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
No minimum to 35 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
cost of treatmentOne month

Secondary

MeasureTime frame
Implantation and pregnancy rates2 months

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026