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Human Menopausal Gonadotropin (HMG) vs Recombinant Follicle Stimulating Hormone (rFSH) in Gonadotropin Releasing Hormone (GnRH) Antagonist Cycles

NCT ID: NCT00669786

Last Updated: 2008-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Ovarian Stimulation

Keywords

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Ongoing Pregnancy Rate

Study Groups

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HMG

Human Menopausal Gonadotropin (HMG)

Group Type ACTIVE_COMPARATOR

Human Menopausal Gonadotropin (HMG) & - Recombinant Follicle Stimulating Hormone (r-FSH)

Intervention Type DRUG

r-FSH

Recombinant Follicle Stimulating Hormone

Group Type ACTIVE_COMPARATOR

Human Menopausal Gonadotropin (HMG) & - Recombinant Follicle Stimulating Hormone (r-FSH)

Intervention Type DRUG

Interventions

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Human Menopausal Gonadotropin (HMG) & - Recombinant Follicle Stimulating Hormone (r-FSH)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role lead

Locations

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Instituto Valenciano de Infertilidad

Valencia, , Spain

Site Status

Countries

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Spain

References

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Bosch E, Vidal C, Labarta E, Simon C, Remohi J, Pellicer A. Highly purified hMG versus recombinant FSH in ovarian hyperstimulation with GnRH antagonists--a randomized study. Hum Reprod. 2008 Oct;23(10):2346-51. doi: 10.1093/humrep/den220. Epub 2008 Jun 25.

Reference Type DERIVED
PMID: 18583332 (View on PubMed)

Other Identifiers

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VLC-EB-0103-0408-1

Identifier Type: -

Identifier Source: org_study_id