Human Menopausal Gonadotropin (HMG) vs Recombinant Follicle Stimulating Hormone (rFSH) in Gonadotropin Releasing Hormone (GnRH) Antagonist Cycles
Information source: Instituto Valenciano de Infertilidad, Spain
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ovarian Stimulation
Intervention: Human Menopausal Gonadotropin (HMG) & - Recombinant Follicle Stimulating Hormone (r-FSH) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Instituto Valenciano de Infertilidad, Spain
Summary
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.
Clinical Details
Official title: Highly Purified Human Menopausal Gonadotropin Versus Recombinant Follicle Stimulating Hormone in Ovarian Hyperstimulation With Gonadotropin Releasing Hormone Antagonists. A Randomized Study.
Study design: N/A
Eligibility
Minimum age: 18 Years.
Maximum age: 37 Years.
Gender(s): Female.
Criteria:
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.
Locations and Contacts
Instituto Valenciano de Infertilidad, Valencia 46117, Spain
Additional Information
Last updated: April 30, 2008
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