Human Menopausal Gonadotropin (HMG) vs Recombinant Follicle Stimulating Hormone (rFSH) in Gonadotropin Releasing Hormone (GnRH) Antagonist Cycles
A randomized controlled trial comparing the ongoing pregnancy rate (primary end-point) in 280 patients undergoing IVF/ICSI after stimulation with hp-hMG or rFSH controlled with a GnRH antagonist. Non significant differences were observed between hp-hMG and rFSH in terms of the ongoing pregnancy rate per started cycle (35.0% vs. 32.1%; p=0.61); R.R: 1.09 (95% CI: 0.78-1.51; Risk Difference: 2.9%)...
Brief Summary
Official Title: “Highly Purified Human Menopausal Gonadotropin Versus Recombinant Follicle Stimulating Hormone in Ovarian Hyperstimulation With Gonadotropin Releasing Hormone Antagonists. A Randomized Study.”
A randomized controlled trial comparing the ongoing pregnancy rate (primary end-point) in 280 patients undergoing IVF/ICSI after stimulation with hp-hMG or rFSH controlled with a GnRH antagonist. Non significant differences were observed between hp-hMG and rFSH in terms of the ongoing pregnancy rate per started cycle (35.0% vs. 32.1%; p=0.61); R.R: 1.09 (95% CI: 0.78-1.51; Risk Difference: 2.9%). No differences were observed for implantation, clinical pregnancy and pregnancy loss rates. Patients receiving rFSH obtained more oocytes (14.4 ± 8.1 vs. 11.3 ± 6.0; p=0.001). Estradiol was higher at the end of stimulation in the hp-hMG group, while Progesterone was higher in patients stimulated with rFSH.
- Study Type: Interventional
- Study Design: N/A
Intervention(s) in this Clinical Trial
- Drug: Human Menopausal Gonadotropin (HMG) & - Recombinant Follicle Stimulating Hormone (r-FSH)
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: HMG
- Human Menopausal Gonadotropin (HMG)
- Active Comparator: r-FSH
- Recombinant Follicle Stimulating Hormone
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- women with good physical and mental health
- aged 18-37 years
- regular menstrual cycles ranging from 25 to 35 days; body mass index (BMI) < 30 kg/m2
- normal basal serum FSH (≤ 10 IU/L) and E2 (≤ 75 pg/mL) levels determined on the day 3 of the cycle previous to COH
- no uterine (fibroids, adenomyosis, mullerian malformations), ovarian (endometrioma, polycystic ovaries) or adnexa (hydrosalpinx) abnormalities assessed by vaginal ultrasound.
Exclusion Criteria:
- patients with a history of recurrent pregnancy loss
- any significant systemic disease, endocrine or metabolic disorder
- having concomitant medication interfering with the purposes of the study
- patients who have received any ovulation induction drug within one month before their inclusion in the study.
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 37 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: Instituto Valenciano de Infertilidad, Spain Other
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00669786
Study ID Number: VLC-EB-0103-0408-1
ClinicalTrials.gov Identifier: NCT00669786
Health Authority: Spain: Ethics Committee
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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00669786
