Ovarian Stimulation With Recombinant Gonadotropins vs. Human Menopausal Gonadotropin in In Vitro Fertilization
NCT ID: NCT02322398
Last Updated: 2014-12-23
Study Results
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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COMPLETED
848 participants
OBSERVATIONAL
2010-03-31
2014-08-31
Brief Summary
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Detailed Description
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Patients in Group A (n=398) had been stimulated either with a starting dose of 150-300 International Units per day (IU/d) recombinant Follicle Stimulating Hormone (rFSH) plus 75-150 IU/d recombinant Luteinising Hormone (rLH) in 2:1 ratio. On day 6-7 of ovarian stimulation, the gonadotropin dose had been adapted according to the ovarian response, always maintaining the same rFSH:rLH ratio.
Patients in Group B (n=450) had received 150-300 IU/d human Menopausal Gonadotropin, eventually adjusting the dose on day 6-7 of ovarian stimulation.
Either medication had been administered within a "long" protocol with Gonadotropin-releasing Hormone (GnRH)-agonist or a "short" protocol with GnRH-antagonist. The COS regimen (type of protocol and type of medication) had been prescribed in the absence of any pre-fixed criteria at the time of prescription by different physicians of the Unit, basing the choice of appropriate dosages on the clinical experience, considering parameters such as age, small antrall follicle count and basal day 3 FSH.
The classical "long" protocol had been performed administering the GnRH-agonist buserelin (900 mcg/d intranasally) from day 21 of the preceding cycle. In the "short" protocol, the GnRH-antagonist cetrorelix had been started at a subcutaneous dose of 0.25 mg/d according to a flexible schedule, when at least one follicle ≥14 mm diameter was observed at ultrasound (US).
COS had been monitored by transvaginal US plus serum estradiol (E2) measurement performed every second day from stimulation day 6-7. From stimulation day 6-7 onward, checkpoints had been performed until at least one dominant follicle had reached 18 mm diameter, with appropriate E2 levels. At this point, ovulation had been triggered by injecting subcutaneously 10,000 IU of human Chorionic Gonadotropin, and transvaginal US-guided oocyte aspiration (OPU) had been performed approximately 36-37 hours after hCG injection under local anesthesia (paracervical block).
Classical IVF or ICSI had followed, according to the clinical indication. After two days of in vitro culture, embryos had been scored and 1-3 of them had been transferred in uteri using a soft catheter under US guidance.
The luteal phase had been supported administering 180 mg/d natural progesterone for 15 days. Pregnancy had been assessed by serum hCG assay after 15 days from embryo transfer and then confirmed if at least one gestational sac was visualized at transvaginal US after two further weeks.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Group A
Patients who had been stimulated with a starting dose of 150-300 IU/d rFSH plus 75-150 IU/d rLH in 2:1 ratio.
rFSH plus rLH
150-300 IU/d rFSH plus 75-150 IU/d rLH in 2:1 ratio
Group B
Patients who had been stimulated with a starting dose of 150-300 IU/d hMG.
hMG
150-300 IU/d hMG
Interventions
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rFSH plus rLH
150-300 IU/d rFSH plus 75-150 IU/d rLH in 2:1 ratio
hMG
150-300 IU/d hMG
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* need to undergo IVF
* circulating basal FSH above 6.5 UI/l
* circulating AMH 0.1-2 ng/ml
* basal antral follicle count between 3 and 15
Exclusion Criteria
* circulating AMH below 0.1 ng/ml or above 2 ng/ml
* basal antral follicle count below 3 or above 15
20 Years
45 Years
FEMALE
No
Sponsors
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University of Turin, Italy
OTHER
Responsible Party
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Alberto Revelli
Director Physiopathology of Reproduction and IVF Unit, S. Anna Hospital
Principal Investigators
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Alberto Revelli, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Physiopathology of Reproduction and IVF Unit, S. Anna Hospital
Locations
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Physiopathology of Reproduction and IVF Unit, S. Anna Hospital
Torino, , Italy
Countries
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Other Identifiers
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FDR-1-2014
Identifier Type: -
Identifier Source: org_study_id